Heart Failure, Heart Failure With Preserved Ejection Fraction
Conditions
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.
Interventions
None listed
Sponsors
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Brigham and Women's Hospital
Mayo Clinic
University of California, Davis
Wake Forest University Health Sciences
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF) | Up to 5 years |
Countries
United States
Contacts
CONTACTLaura Alagna
PRINCIPAL_INVESTIGATORSanjiv Shah, MD
Northwestern University
STUDY_CHAIRSvati Shah, MD, MHS
Duke University
STUDY_CHAIRJaved Butler, MPH, MBA
Baylor Scott and White Health
Outcome results
None listed