HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Su… (NCT05873634) | Clinical Trial Compass
RecruitingNot Applicable
HeartShare: Combining Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets
United States1,000 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range30 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. For non-HF group: any prior known left ventricular ejection fraction \<50%.
✕. Prior history of solid organ transplantation.
What they're measuring
1
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
. 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).