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HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets

HeartShare Deep Phenotyping Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

HeartShare studies health records, heart images, and blood data to better group types of heart failure and help guide future treatments. It includes adults age 30 and older with or without heart failure, a condition where the heart cannot keep up with the body’s needs.

HeartShare is a comprehensive study of heart failure, a common and serious medical condition which occurs when the heart is unable to keep up with the demands of the body, resulting in shortness of breath, fluid retention, and fatigue. HeartShare aims to better classify heart failure into subtypes to help develop more personalized treatments for patients, with the hope that this will improve the lives of heart failure patients. To do this, HeartShare is bringing together a large amount of data (including images, such as heart ultrasounds and MRIs and molecular data from the blood, such as genetics) from previously conducted studies and electronic health records, and is gathering new data through participants enrolled in the HeartShare Deep Phenotyping Study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All groups: You must be age 30 or older. Other rules depend on which study group you join.
  • Registry heart failure group: Your electronic health record must show a past heart failure diagnosis. Any heart pumping strength is allowed.
  • Registry group without heart failure: You must have no known heart failure or use of loop diuretics, a type of water pill. Past blood tests, if available, must not show BNP above 100 or NTproBNP above 300. These tests measure signs of heart strain.
  • Detailed study, both groups: A heart ultrasound must show an ejection fraction of at least 50%. This is the share of blood the heart pumps out with each beat.
  • Detailed study, heart failure group: You must have heart failure signs and symptoms that limit activity or occur at rest, even though your heart’s pumping strength is preserved.
  • Detailed study, heart failure group: You also need at least one qualifying finding: high heart-strain blood tests, a past heart failure hospital stay, high pressure measured inside the heart, or a high heart failure assessment score.
  • Detailed study, group without heart failure: You must have no known heart failure or use of water pills to manage fluid. Past tests, if available, must not show BNP of 75 or higher or NTproBNP of 225 or higher. At screening, BNP must be below 75 or NTproBNP below 225.

Who can't join

  • Both studies: Past solid organ transplant, use of a device to support blood flow, liver scarring not caused by heart disease, or inability to give written consent.
  • Registry group without heart failure: Any known past ejection fraction below 50%.
  • Detailed study: Certain heart muscle diseases, certain types of high blood pressure in the lungs, or significant heart valve disease.
  • Detailed study: Past ejection fraction below 40%, unless it happened only during a sudden fast heartbeat episode; current sudden worsening of heart failure; or untreated artery blockages on the heart’s surface that cause symptoms.
  • Detailed study: Planned heart surgery or procedure within 3 months; certain heart or neck artery procedures, a sudden heart artery problem, stroke, or mini-stroke within 6 months; or an unplanned hospital stay within 2 weeks.
  • Detailed study: Life expectancy under 1 year, very poor kidney function or dialysis, or pregnancy.
  • Detailed study: Past HIV, hepatitis B or C, or tuberculosis, unless treated and judged inactive by the study doctor.
  • Detailed study: Another main cause of breathing or exercise problems in the heart failure group, or any condition the study doctor believes would prevent participation or following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: HF Inclusion Criteria (HeartShare Registry) 1. Age ≥30 years. 2. Prior diagnosis of HF in the EHR (any left ventricular ejection fraction). Non-HF Group Inclusion Criteria (HeartShare Registry) 1. Age ≥30 years. 2. No known prior diagnosis of HF or use of loop diuretics. 3. No known prior history of BNP \>100 pg/ml or NTproBNP \>300 pg/ml, if prior laboratory tests are available in the EHR. HFpEF Inclusion Criteria (HeartShare Deep Phenotyping Cohort) 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography. 3. Definition of HFpEF: signs and symptoms of HF, NYHA functional class II-IV, and at least one of the following: 1. Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrial fibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center. 2. 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). 3. 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). 4. Elevated H2FPEF score26 (≥5) or HFA-PEFF27 score (≥5). Non-HFpEF Group Inclusion Criteria (HeartShare Deep Phenotyping Cohort) 1. Age ≥30 years. 2. Left ventricular ejection fraction ≥50% measured by echocardiography. 3. No known prior diagnosis of HF or use of diuretics for fluid management. 4. No known prior history of BNP ≥75 pg/ml or NTproBNP ≥225 pg/ml, if prior laboratory tests are available in the EHR. 5. BNP \<75 pg/ml or NTproBNP \<225 pg/ml at the time of screening. Choice of BNP or NTproBNP is based on availability at each clinical center. Exclusion Criteria: Exclusion Criteria (HeartShare Registry) The following exclusion criteria apply to both HF and non-HF group participants, unless otherwise indicated. 1. For non-HF group: any prior known left ventricular ejection fraction \<50%. 2. Prior history of solid organ transplantation. 3. Prior history of mechanical circulatory support. 4. Prior history of non-cardiac cirrhosis. 5. Inability to provide written consent to the study. Exclusion Criteria (HeartShare Deep Phenotyping Cohort) The following exclusion criteria apply to both HFpEF and non-HFpEF group participants, unless otherwise indicated. 1. Life expectancy estimated to be \< 1 year. 2. 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). 3. 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). 4. Clinically significant valvular heart disease defined as: 1. Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis. 2. Any mitral stenosis. 3. Moderate or greater aortic regurgitation. 4. Greater than moderate mitral regurgitation. 5. Any planned cardiac surgery or cardiac intervention in the next 3 months. 6. Alternative primary reason for symptoms of shortness of breath and exercise intolerance in HFpEF participants in the opinion of the enrolling investigator. 7. Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention, stroke, transient ischemic attack, or carotid intervention in the preceding 6 months prior to enrollment. 8. Known symptomatic epicardial coronary artery disease that is not revascularized. 9. Any non-elective hospitalization in the preceding 2 weeks. 10. Prior history of solid organ transplantation. 11. Prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator. 12. Prior history of mechanical circulatory support. 13. Prior history of non-cardiac cirrhosis. 14. Estimated GFR \<20 ml/min/1.73m2 or currently on dialysis. 15. Any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator. 16. Inability to provide written consent to the study. 17. Current acute decompensated heart failure. 18. Currently pregnant.

Study sites (6)

CA

  • University of California Davis · Sacramento, CA 95817Maiya Her · Study contact · 916-734-0230Nipavan Chiamvimonvat, MD · Principal investigatorJavier Lopez, MD · Sub-investigatorMartin Cadeiras, MD · Sub-investigatorMore trials in Sacramento

IL

MA

MN

NC

  • Wake Forest University · Winston-Salem, NC 27157Ben Nelson · Study contact · 336-716-6789Dalane Kitzman, MD · Principal investigatorAlain Bertoni, MD, MPH · Sub-investigatorMore trials in Winston-Salem

PA