Clinical trial Recruiting at 4 sites Observational Ages 30 and up

HeartShare combines various data to improve heart failure treatment

Official title: HeartShare Deep Phenotyping Study

Run by Northwestern University · NCT05873634 · Data updated 2026-11-12

This study is trying to see if using different types of health data can help doctors create better, personalized treatments for people with heart failure.

Quick facts

Study typeObservational
Ages30 Years and up
SexAll
Enrollment1000 (estimated)
SponsorNorthwestern University
Academic / other
Locations6 sites (Sacramento, California and 5 other locations)
StatusRecruiting
StartedMarch 1, 2023
Main results expectedDecember 2027
Study endsDecember 2028
Registry record updatedSeptember 29, 2026
Trial IDNCT05873634 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 30 and older with a prior diagnosis of heart failure or those without a history of heart failure.

Probably not a fit

Patients with significant comorbidities that preclude participation or those under 30 years old may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HeartShare is an observational study focused on heart failure, aiming to classify the condition into subtypes for personalized treatment development. The study integrates extensive data from electronic health records, imaging studies, and molecular data to enhance understanding of heart failure. Participants will contribute new data through the HeartShare Deep Phenotyping Study, which will help identify specific treatment targets for different heart failure subtypes. By leveraging a comprehensive approach, the study seeks to improve outcomes for heart failure patients.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatments for heart failure patients.

How similar studies have gone: Other studies have shown promise in using integrated data approaches for heart failure, suggesting potential success for this novel methodology.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University of California Davis
    Sacramento, California, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois, United States
    Recruiting
  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Mass General Brigham
    Boston, Massachusetts, United States
    Not yet recruiting
  • Wake Forest University
    Winston-Salem, North Carolina, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Pulmonary Artery Denervation for a specific type of heart and lung pressure problem

    This study tests whether the Enhancor System can safely and effectively help patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease when added to standard therapy.

    Recruiting at 18 sites Pulnovo Medical, Inc. · Tucson, Arizona and 18 other locations · NCT07214376

  • Using Apple Watch data to predict heart failure outcomes

    This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

    Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

  • Identifying heart tissue changes in patients with heart failure

    This study looks at changes in heart tissue of people with heart failure to see if it can help find better treatments for their condition.

    Recruiting at 6 sites Northwestern University · Chicago, Illinois and 5 other locations · NCT06517186

  • Comparing Aortix Device to Diuretics for Acute Heart Failure

    This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

    Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

  • Optimizing beta-blocker use in older adults with heart failure

    This study is trying to see if a personalized approach to adjusting beta-blocker medication can help older adults with heart failure feel more confident in their treatment and manage their condition better.

    Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT05585125

  • Evaluating Cardiac Contractility Modulation in Heart Failure Patients

    This study is testing a new heart treatment called Cardiac Contractility Modulation to see if it can help people with heart failure feel better and improve their heart function.

    Recruiting at 65 sites Impulse Dynamics · Birmingham, Alabama and 66 other locations · NCT05064709

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.