- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873634
HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets
HeartShare Deep Phenotyping Study
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Laura Alagna
- Phone Number: 312-695-6765
- Email: heartsharestudy@northwestern.edui
Study Locations
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California
-
Sacramento, California, United States, 95817
- Recruiting
- University of California Davis
-
Contact:
- Maiya Her
- Phone Number: 916-734-0230
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Principal Investigator:
- Nipavan Chiamvimonvat, MD
-
Sub-Investigator:
- Javier Lopez, MD
-
Sub-Investigator:
- Martin Cadeiras, MD
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
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Contact:
- Laura Alagna
- Phone Number: 312-695-6765
- Email: laura.alagna@northwesterne.du
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Principal Investigator:
- Sadiya Khan, MD
-
Principal Investigator:
- Laura Rasmussen-Torvik, PhD, MPH
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Not yet recruiting
- Mass General Brigham
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Principal Investigator:
- Greg Lewis, MD
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Contact:
- Diane Cocca-Spofford
- Phone Number: 617-726-8228
- Email: dcoccaspofford@mgh.harvard.edu
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Sub-Investigator:
- Akshay Desai, MD, MPH
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Sub-Investigator:
- Michael Givertz, MD
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Sub-Investigator:
- Scott Solomon, MD
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Principal Investigator:
- Barry Borlaug, MD
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Contact:
- Janet Gatzke, RN
- Phone Number: 507-284-3994
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Sub-Investigator:
- Margaret Redfield, MD
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Not yet recruiting
- Wake Forest University
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Contact:
- Ben Nelson
- Phone Number: 336-716-6789
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Principal Investigator:
- Dalane Kitzman, MD
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Sub-Investigator:
- Alain Bertoni, MD, MPH
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
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Contact:
- Tiffany Sharkoski
- Phone Number: 215-615-2354
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Principal Investigator:
- Julio Chirinos, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
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.
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
HFpEF
Participants with HFpEF
|
Non-HFpEF
Participants without HFpEF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sanjiv Shah, MD, Northwestern University
- Study Chair: Svati Shah, MD, MHS, Duke University
- Study Chair: Javed Butler, MPH, MBA, Baylor Scott and White Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00217900
- U54HL160273 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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