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Heart FailureNCT05873634

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

An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Northwestern University at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
How many people
1,000 participants
Where
6 sitesUnited States
Study dates
1 Mar 2023to Dec 2028
How long will I take part?
4 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults over 30 years of age.

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Exclusion Criteria (HeartShare Registry) The following exclusion criteria apply to both HF and non-HF group participants, unless otherwise indicated.
  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Alagna contact

312-695-6765

heartsharestudy@northwestern.edui

6 sites in 1 country

United States6 sites, 6 recruiting

  • Mass General Brigham

    Boston, Massachusetts, 02114

    Diane Cocca-Spofford, 617-726-8228, dcoccaspofford@mgh.harvard.edu

    Greg Lewis, MD

    Not yet recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Laura Alagna, 312-695-6765, laura.alagna@northwesterne.du

    Sadiya Khan, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Tiffany Sharkoski, 215-615-2354

    Julio Chirinos, MD, PhD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Matthew Adolphsen, 507-422-5919, Adolphsen.Matthew@mayo.edu

    Barry Borlaug, MD

    Recruiting

  • University of California Davis

    Sacramento, California, 95817

    Maiya Her, 916-734-0230

    Nipavan Chiamvimonvat, MD

    Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

    Ben Nelson, 336-716-6789

    Dalane Kitzman, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: HeartShare Deep Phenotyping Study

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.

Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05873634
Study groupRoleWhat they receive
HFpEFParticipants with HFpEF
Non-HFpEFParticipants without HFpEF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start1 Mar 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05873634
Sponsor's protocol ID
STU00217900
Other IDs
U54HL160273
Status last verified
Sep 2026
First submitted
15 May 2023
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Northwestern University at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Alagna (312-695-6765, heartsharestudy@northwestern.edui), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05873634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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