Single-cell Gastric Epigenomics and Transcriptomics in Humans
Gastric Epigenome and Transcriptome in Humans
- Male or female patients, aged 18 years and older.
- Scheduled to undergo gastric surgery for obesity.
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Individuals < 18 years old.
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.
- Medications. Opiates and high doses of anticholinergic agents (e.g., amitriptyline greater than 50 mg daily).
- Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.
Eligibility last updated 9/1/21. Questions regarding updates should be directed to the study team contact.
BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy (UH3BLIS)
• individuals between 18
•60 years who weigh at least 50kg
• pass pre-donation screening using the NBSG standardized donor screening questionnaire
• vital signs meet the NBSG requirement for blood donation
• non-contact forehead temperature not exceeding 37.5°C
• meeting acceptable requirements for skin lesions, needle marks and physical appearance.
• willingness and ability to consent
• understands one of English, Twi, Ewe, or Ga
• deferred for low haemoglobin
• intend to remain in the study during the entire length of the study
• persons who have used iron supplementation within the past one month
• potential donors who are found to have haemoglobin Hb < 10g/dl (females) and Hb<11g/dl (males) at screening
Is EPO Staining on Esophageal Sponge Samples a Simple Reliable Method of Accessing Esophageal Eosinophilia?
Sponge and Eosinophil Peroxidase (EPO) Staining
- 18 to 70 years of age
- Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy
- Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk
- Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
- Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- Esophageal minimal diameter < 13 mm on structured barium esophagram
Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty
Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient TJA
- Adult patients age ≥ 18.
- Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.
- Individuals < 18 years of age.
Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.
Impact of Dermoscopy with TADA – Triage Amalgamated Dermoscope Algorithm – Utilization within Primary Care
Dermoscopy Impact with TADA in Primary Care
- Primary care clinicians in Rochester/Kasson who complete the pre/posttests, dermoscopy education and conducts skin lesion visits in their practice.
- Patient refusal for dermoscopy skin lesion photo (skin lesion would then be excluded), dermoscopy image not captured by clinician at visit.
Eligibility last updated 8/18/22. Questions regarding updates should be directed to the study team contact.
Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion
Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion
- Adults
- Standard exclusion criteria for clinical MRI; e.g. cardiac pacemaker, claustrophobia, an implanted device that has been determined to be MR conditional at 1.5T but not at 3T, anticipated considerable susceptibility artifact from hip prosthesis, etc.
- previous rectal surgery which may preclude tolerance of an endorectal coil
Stress Echocardiography in Mixed and Multi Valvular Heart Disease
Stress Echocardiography in Mixed and Multi Valvular Heart Disease
- All adult patients with at least moderate mx/ml-VHD and those with at least moderate single valve disease who had underwent a clinically indicated stress echocardiography study for their VHD prior to the date of IRB submission.
- All adult patients who would be scheduled for a clinically indicated stress echo study in the future (from the date of IRB submission, up to 31st Dec 2022).
- Patients < 18 years old
Body Composition and Fluid Status Using Non-Invasive Impedance
Body Composition and Fluid Status Using Non-Invasive Impedance
- Patient at Mayo Clinic – Rochester
- 18 years of age or older
- None
Associations between asymmetrical spinal loading, age, and disc degeneration
Asymmetrical Spinal Loading, Age, and Disc Degeneration Associations
- Patients will be recruited if they already have MRI scans, DXA scans for bone mineral density, and radiographs of the lumbar spine within the last year.
- Three patient groups will be recruited; the first group includes twenty healthy patients with no history of spine disorders or low back pain. The second group includes twenty patients with symptomatic DD, according to the Pfirrmann grading system. The third group includes scoliotic patients (with deformity ≥ 15°).
-
Individuals with prior spine, knee, or hip surgery within the last year will be excluded. Patients without imaging data will be excluded. Patients who are not able to perform the physical activities will be excluded. BMI ≥ 35.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/11/23. Questions regarding updates should be directed to the study team contact.
Role of 3D Echocardiography Volumetric Measurements in Patients with or without Valvular Heart Disease
3D Echocardiography Volumetric Measurements in Patients with or without Valvular Heart Disease
Patients undergoing routine echocardiography
- Subjects with poor apical images
- Patients with congenital heart anomalies
- Patients with multivalvular disease
Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock
• Age 18-75 years
• SCAI D/E CS requiring VA-ECMO support based on treating team's judgement.
• MAP >65 mmHg on <3 vasopressors/inotropes at the time of consent
• Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice
• VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension
• CS due to other (non-ACS) etiologies
• Known patient with severe left ventricular dysfunction and stage IV NYHA heart failure being evaluated for or with a history of LVAD and transplantation prior to commencement of VA-ECMO
• Profound vasoplegia with MAP <65 mmHg on 3 vasopressors/inotropes
• Moderate to severe aortic regurgitation (contraindication to VA-ECMO)
• Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter)
• Bleeding complications requiring ongoing transfusions of blood products
• Ischemic lower extremities
• Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation)
• Evidence of sepsis or septic shock
• Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)
Feasibility of Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension (PAH)
Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension
- Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).
- Age ≥ 18 years.
- On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
- NYHA class II-III symptoms.
- able to complete a six-minute walk test.
- Patients experiencing syncope or exertional syncope.
- Patients not experiencing exertional dyspnea.
- Inability to walk.
- Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).
Eligibility last updated 3/14/22. Questions regarding updates should be directed to the study team contact.
Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel
• 18- 80 years of age
• One of the following histologies:
• Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or
• Primary mediastinal B-cell lymphoma, or
• High grade B-cell lymphoma, or
• DLBCL arising from follicular lymphoma
• Disease status:
• Chemotherapy refractory disease after ≥2 lines of chemotherapy, or
• Relapsed with no remission after ≥1 lines of salvage chemotherapy, or
• Relapsed following autologous hematopoeitic stem cell transplantation (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post auto HCT, the subject must have no complete response, or relapse after the last line of therapy
• Performance Status
• ECOG performance status 0-2
• Adequate organ function defined as:
• Renal function defined as:
• eGFR ≥ 30 mL/min/1.73 m^2
• Liver function defined as:
• ALT and AST ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA
• Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment as outlined in axi-cel protocol.
• Able to provide written voluntary consent (or LAR consent for adults with diminished capacity) prior to the performance of any research related tests or procedures
• Availability of a certified practitioner to perform the lumbar punctures
• Allergies, or intolerance to simvastatin or dexamethasone
• Already receiving a statin drug for hypercholesterolemia and unwilling to change medication to 40 mg/day of simvastatin
• Active uncontrolled CNS lymphoma. Patients with history of CNS lymphoma who have been adequately treated are eligible
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD).
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection
• Unstable angina and/or myocardial infarction
• Risk factors that preclude a safe lumbar puncture (high intracranial pressure, bleeding diathesis that cannot be reversed or corrected, need for uninterrupted anticoagulation, platelets < 50K that cannot be corrected with transfusional support
• Pregnant or breastfeeding as agents used in this study are Pregnancy Category C (dexamethasone) and X (simvastatin). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of study registration.
Novel Structural and functional connectivity MRI Markers in Multiple Sclerosis
MRI Markers in Multiple Sclerosis
- age >18
- Healthy control volunteers
- Patients with Multiple Sclerosis (Relapsing remitting multiple sclerosis and progressive multiple sclerosis)
Exclusion criteria:
Patients with anxiety or claustrophobia
Visual Function and Corneal Health Status in Fuchs Dystrophy II
Visual Function and Corneal Health Status in Fuchs Dystrophy II
- Participants undergoing corneal endothelial transplantation because of corneal endothelial dysfunction
- Any age (expected range will be 40-90 in FECD)
- Any sex or race
-
Corneal disease other than FECD
Erectile Restoration Outcomes and Satisfaction (EROS) Penile Prosthesis Registry (EROS)
Erectile Restoration Outcomes and Satisfaction (EROS) Penile Prosthesis Registry
- Patients must be considered suitable candidates for a penile prostheses as dictated by the surgeon.
- All stages of PP surgery will be included: primary implants, revision, salvage, infected.
- Patients with prior histories of penile prostheses will have data obtained about their prior devices where available. This information will include the number of devices, penile prostheses-related surgeries, and complications relating to these procedures.
- Each time a new device or new component is placed (revision, salvage) will result in a new data entry point.
Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository- HS PROGRESS
Hidradenitis Suppurativa Registry
- Male or female, ≥ 10 years of age.
- Diagnosis of Hidradenitis Suppurativa (HS) by a dermatologist or practitioner experienced in making a diagnosis of HS.
- Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study.
- Immediate family members (for saliva and genetics data).
- Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
• Ages 12 to = 20 years at study entry
• Obesity (BMI >/= the 95th percentile for age and sex)
• HgbA1c >/= 6.5% at type 2 diabetes diagnosis
• Negative diabetes auto-antibodies
• English-speaking
• For participants of child-bearing potential: when sexually active, agreement to use two forms of highly effective contraception (oral contraceptive pill, IUD, implant, and/or condoms) during study participation
• Pregnancy or lactation
• Newly-initiated or change in dose of weight altering medication within past 6 months, including SGLT-2 inhibitors and DPP-IV inhibitors
• Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination PHN/TPM, liraglutide, semaglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
• Current use of sulfonylureas
• Previous metabolic/bariatric surgery
• Current use of a stimulant medication
• History of glaucoma
• Current or recent (< 14 days) use of monoamine oxidase inhibitor or carbonic anhydrase inhibitors
• Known hypersensitivity to sympathomimetic amines
• Any history of treatment with growth hormone
• any history of bulimia nervosa
• Major psychiatric disorder as determined by the local medical monitor
• Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression or PHQ-9 score of >/= 15
• Any history of active suicide attempt, a "yes" answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) on the "Suicidal Ideation" portion of the C-SSR, or a "yes" to answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS
• History of suicidal ideation or self-harm within the previous 30 days or a "yes" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the C-SSRS and the ideation or behavior occurred within the past month.
• Current pregnancy or plans to become pregnant during study participation
• Current tobacco use
• ALT or AST >/= 3 times the upper limit of normal
• Moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15)
• Bicarbonate <18 mmol/L
• Moderate (creatinine clearance [CrCl] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment
• Any history of seizures • BP for ages 13 and older of > 130/80 on 3 separate measurements and for age 12 > 95th percentile on 3 separate measurements
• HR ≥120 bpm on 3 separate measurements
• History of structural heart defect or clinically significant arrhythmia
• Diagnosed monogenic obesity
• Any history of cholelithiasis
• Any history of nephrolithiasis
• Clinically diagnosed hyperthyroidism
• Untreated thyroid disorder or TSH below the lower laboratory limit of normal
• Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion may put the participant at risk
REST/NRSF, miRNAs and Tissue Remodeling in Adenomyosis Pathophysiology (REST.NSRF)
Tissue Remodeling in Adenomyosis Pathophysiology
Inclusion Criteria;
- Pre-menopausal (21
•50 years of age). - Study group will consist of women seeking hysterectomy for possible adenomyosis adenomyomectomy.
- Controls will consist of women seeking hysterectomy for uterine prolapse or pelvic pain or transgender men prior to androgen treatment and whose pathology shows a uterus < 100 grams with no evidence of adenomyosis, endometriosis, or leiomyomas.
- No ua\se of GnRH analogues, aromatase inhimitors, selective E2 or P4 receptor modulators, oral contraceptives, or immunotherapy within 3 months prior to surgery in any patient.
- No history /confirmation or suspicion of autoimmune disease, fibromyalgia, endometriosis, or leiomyomas in any patient.
- No current or previous history of STDs, pelvic inflammatory disease, endometrial/cervical cancer in any patient.
- Women who do not exhibit menstrual cycles.
Eligibility last updated 10/21/21. Questions regarding updates should be directed to the study team contact.
Improving Carpediem Outcomes in Neonates and Infants Through Collaboration (ICONIC)
ICONIC: Improving Carpediem Outcomes in Neonates and Infants Through Collaboration
- Treated with CARPEDIEM as part of standard of care at a participating institution.
- Within the United States.
- Parents/legally authorized representative unable or unwilling to provide consent.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/12/22. Questions regarding updates should be directed to the study team contact.
Measuring Endoscopic Stone Size in Ureteroscopic Renal Surgery (MESSURES)
Real-Time Ureteroscopic Stone Measurement Impact and Decision Making
Inclusion Criteria:
- Must be ≥ 18 years old.
- Individual undergoing elective ureteroscopy and laser lithotripsy for renal or ureteral stones.
- Under 18 years of age.
- Individual cannot be undergoing elective ureteroscopy and laser lithotripsy for renal or ureteral stones.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/20/23. Questions regarding updates should be directed to the study team contact.
Reliability of a Modified King Devick Balance Test in Hockey Players While Wearing Skates (KD)
Balance Test in Hockey Players While Wearing Skates
- Male and female participants.
- Age 14-20 years old.
- No diagnosed concussion within the past 3 months.
- Participating in organized traveling, high school, or junior hockey.
- Any medical restriction or injury that would limit the ability to perform a balance screen.
- Diagnosed concussion within the past 3 months.
Optimizing Outcomes of Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
A Study Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
Inclusion Criteria:
- Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies.
- Have radiographically measurable disease by RECIST.
- Eligible for atezolizumab/bevacizumab front line therapy.
- Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent.
- Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan.
- Patients with higher than the weight/size limitations of PET/CT scanner.
Autotransfusion During Intralesional Tumor Resection: Effectiveness of Leukocyte Reduction Filtration in Removing Neoplastic Cells (CSDTR)
Cell Saver During Tumor Resection
- Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.
- Patients undergoing surgery with an expected blood loss of less than 135cc.
- Provisions for inclusion of minorities:
- Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.
Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.
North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC) (NAMDC)
North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)
- Patients diagnosed with or suspected to have a mitochondrial disorder
- Adult carriers of known mitochondrial DNA mutations
- Patients with laboratory analysis indicative of a mitochondrial disorder.
- Medical information and tissue samples are also accepted from deceased individuals who fulfill the above criteria.
- Patients not suspected of having a mitochondrial disorder
- Patients not suspected of carrying a mitochondrial DNA or nuclear DNA mutation that affects mitochondrial function.
ASCEND-ARDS in Children and ECMO Initiation Strategies Impact on Neuro-Development
ARDS in Children and ECMO Impact on Neuro-Development (ASCEND)
- Children aged 14 days
•17 years. - At least moderate PARDS, bilateral lung disease, intubated within four days of severe PARDS and no exclusion criteria.
- Children will be excluded if they have any of the following at the start of mechanical ventilation: perinatal related lung disease, congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis, respiratory failure explained by cardiac failure or fluid overload, cyanotic heart disease, cardiomyopathy, unilateral lung disease, primary pulmonary hypertension, status asthmaticus (patient with a severe asthma exacerbation. A previous history of asthma or the use of bronchodilators is NOT an exclusion if the primary disease process is not considered to be obstructive airway disease), obstructive airway disease (e.g., severe airways disease without parenchymal involvement or disease characterized by hypercapnia with FiO2 < 0.30 and/or evidence of increased resistance visible on the flow – time scalar and/or presence of intrinsic PEEP), bronchiolitis obliterans, post Hematopoietic Stem Cell Transplant, post lung transplant, home ventilator (including noninvasive) dependent, neuromuscular respiratory failure, critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass), facial surgery or trauma in previous 15 days, head trauma, intracranial bleeding, unstable spine, femur or pelvic fractures, acute abdominal process/open abdomen, supported on ECMO, previously enrolled in current study, family/medical team deciding not to provide full support, enrolled in any other critical care interventional clinical trial concurrently and known pregnancy.
Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.
Optimizing Pancreatic Cancer Management with Next Generation Imaging and Liquid Biopsy
Optimizing Pancreatic Cancer Management Using Next Generation Imaging and Liquid Biopsy
- Adults ≥ 18 years with treatment-naïve biopsy-proven PDA or with findings diagnostic for PDA on baseline imaging (CT, MRI or PET).
- Localized disease expected to undergo surgical resection following NAT.
- ECOG performance status of 0-2.
- Ability to provide informed consent.
- Non-PDA histology on biopsy.
- No baseline PET/CT or PET/MRI.
- Histopathologically proven metastatic PDA.
- Non-FDG avid PDA on baseline PET/CT or PET/MRI.
- Pregnant women.
Eligibility last updated8/25/21. Questions regarding updates should be directed to the study team contact.
Evaluating Raised Intracranial Pressure Using MR Elastography and/or ultrasound elastography
Evaluating Raised Intracranial Pressure Using MR Elastography
- Male or female, ≥ 18 year of age.
- Group 1: : Papilledema from idiopathic intracranial hypertension and others suspected of elevated intracranial pressure, including obstructive hydrocephalus, or suspected biomechanical changes to the eye, such as choroidal fold.
- Group 2: Patients without raised intracranial pressure.
- Age < 18.
- Pregnancy (self-reported).
- Individuals for whom MR is contraindicated.
Eligibility last updated 10/27/21. Questions regarding updates should be directed to the study team contact.
Mayo Clinic HeartShare
Heartshare Heart Failure and Heart Failure With Preserved Ejection Fraction Registry
HF Inclusion Criteria (HeartShare Registry):
- Age ≥ 30 years.
- Prior diagnosis of HF in the EHR (any left ventricular ejection fraction).
Non-HF Group Inclusion Criteria (HeartShare Registry):
- Age ≥ 30 years.
- No known prior diagnosis of HF or use of loop diuretics.
- No known prior history of BNP >100 pg/ml or NTproBNP > 300 pg/ml, if prior laboratory tests are available in the EHR.
Exclusion Criteria (HeartShare Registry):
- For non-HF group: any prior known left ventricular ejection fraction <50%.
- Prior history of solid organ transplantation.
- Prior history of mechanical circulatory support.
- Prior history of non-cardiac cirrhosis.
- Inability to provide written consent to the study.
HFpEF Inclusion for the HeartShare Deep Phenotyping Cohort:
- Age ≥ 30 years.
- Left ventricular ejection fraction ≥ 50% measured by echocardiography.
- Definition of HFpEF: signs and symptoms of HF, NYHA functional class II-IV, and at least one of the following:
- Elevated BNP (> 100 pg/ml in sinus rhythm or > 300 pg/ml in atrial fibrillation/flutter) or NTproBNP (> 300 pg/ml in sinus rhythm or > 900 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center;
- Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels [using the thresholds listed above], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography);
- Elevated pulmonary capillary wedge pressure (PCWP) at rest (≥ 15 mmHg) or during exercise (≥ 25 mmHg for supine exercise or PCWP/cardiac output ratio ≥ 2 mmHg/L/min for upright exercise);
- Elevated H2FPEF score26 (≥ 5) or HFA-PEFF27 score (≥ 5).
Non-HFpEF Group Inclusion Criteria (HeartShare Deep Phenotyping Cohort):
- Age ≥ 30 years.
- Left ventricular ejection fraction ≥ 50% measured by echocardiography.
- No known prior diagnosis of HF or use of diuretics for fluid management.
- No known prior history of BNP > 100 pg/ml or NTproBNP > 300 pg/ml, if prior laboratory tests are available in the EHR.
- BNP < 100 pg/ml or NTproBNP < 300 pg/ml at the time of screening. Choice of BNP or NTproBNP is based on availability at each clinical center.
Exclusion Criteria (HeartShare Deep Phenotyping Cohort):
- Life expectancy estimated to be < 1 year.
- Primary cardiomyopathy (including amyloid, hypertrophic cardiomyopathy, cardiac sarcoidosis, hemochromatosis, or other infiltrative cardiomyopathies) or pulmonary arterial hypertension (WHO Group I, III, or IV pulmonary hypertension).
- Any prior known left ventricular ejection fraction <40%, except if this occurred only in the setting of an acute tachycardia episode (e.g., acute atrial fibrillation).
- Clinically significant valvular heart disease defined as:
- Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis;
- Any mitral stenosis;
- Moderate or greater aortic regurgitation;
- Greater than moderate mitral regurgitation.
- Any planned cardiac surgery or cardiac intervention in the next 3 months.
- Alternative primary reason for symptoms of shortness of breath and exercise intolerance in HFpEF participants in the opinion of the enrolling investigator.
- Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention, stroke, transient ischemic attack, or carotid intervention in the preceding 6 months prior to enrollment.
- Known symptomatic epicardial coronary artery disease that is not revascularized.
- Any non-elective hospitalization in the preceding 2 weeks.
- Prior history of solid organ transplantation.
- Prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator.
- Prior history of mechanical circulatory support.
- Prior history of non-cardiac cirrhosis.
- Estimated GFR < 20 ml/min/1.73m^2 or currently on dialysis.
- Any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator.
- Inability to provide written consent to the study.
- Current acute decompensated heart failure.
- Currently pregnant.
- Uncontrolled heart rate (> 110 bpm) at time of screening.
Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.
Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?
Pulmonary Rehabilitation in End-Stage Liver Disease
- Wait listed for liver transplantation with poor 6 MWT
- Age < 18 years
- Recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month
- Large esophageal varices without primary prophylaxis
- Active excessive alcohol intake (in the previous 3 months)
- Current overt uncontrolled hepatic encephalopathy
- Hepatopulmonary syndrome with uncontrolled hypoxia
- Portopulmonary hypertension
- Inability to perform exercise
- Marked symptomatic comorbidities (cardiac, pulmonary, renal)