NCT05873634 · Northwestern University
HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. HFpEF Inclusion Criteria (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 (≥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.
- 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 ≥75 pg/ml or NTproBNP ≥225 pg/ml, if prior laboratory tests are available in the EHR.
- 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
- 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. Exclusion Criteria (HeartShare Deep Phenotyping Cohort) The following exclusion criteria apply to both HFpEF and non-HFpEF group participants, unless otherwise indicated.
- 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/1.73m2 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.
Where
- Sacramento, California
- Chicago, Illinois
- Boston, Massachusetts
- Rochester, Minnesota
- Winston-Salem, North Carolina
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations