HeartShare study aims to crack the code of heart failure
NCT ID NCT05873634
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is looking at 1,000 people with and without heart failure to better understand the different types of the condition. Researchers will use heart images and blood tests to find patterns that could lead to more personalized treatments. The goal is to improve care for people with heart failure.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults over 30 years of age.
- Ages
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30 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Mass General Brigham
NOT_YET_RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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University of California Davis
RECRUITINGSacramento, California, 95817, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Wake Forest University
NOT_YET_RECRUITINGWinston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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