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

NCT05873634 | Recruiting

• 2 other identifiers: STU00217900U54HL160273
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Heart Failure; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

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

  Up to 5 years

Study Arms (2)

HFpEF

Participants with HFpEF

Non-HFpEF

Participants without HFpEF

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults over 30 years of age.

You may qualify if:

• Age ≥30 years.
• Prior diagnosis of HF in the EHR (any left ventricular ejection fraction).
• 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.
• 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).
• Age ≥30 years.
• Left ventricular ejection fraction ≥50% measured by echocardiography.
• No known prior diagnosis of HF or use of diuretics for fluid management.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Mayo Clinic: collaborator
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator
• University of California, Davis: collaborator
• University of Pennsylvania: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (6)

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Mass General Brigham

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, RNA, DNA, urine, saliva, and stool samples will be collected.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sanjiv Shah, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Svati Shah, MD, MHS

  Duke University

  STUDY CHAIR

• Javed Butler, MPH, MBA

  Baylor Scott and White Health

  STUDY CHAIR

Central Study Contacts

Laura Alagna

CONTACT

312-695-6765; heartsharestudy@northwestern.edui

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stone Endowed Professor of Medicine, Director of Research, Bluhm Cardiovascular Institute, Principal Investigator, HeartShare Data Translation Center

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (6)