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Recruiting NCT05873634

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

Conditions: Heart Failure, Heart Failure With Preserved Ejection Fraction

Sex: All
Ages: 30 Years – N/A
Healthy volunteers: Yes
Enrollment: 1000
Sponsor: Northwestern University

Location: University of California Davis Sacramento California

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.

Eligibility 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 \

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Source: ClinicalTrials.gov (NCT05873634). StuddyBuddy aggregates publicly available trial information.