HeartShare

Brief description of study

The overall goal of the HeartShare Deep Phenotyping Study is to create a rich repository of data (e.g., demographic, social determinants of health, clinical, physiological, laboratory), images, and multi-omics (blood and tissue samples) that will serve as a resource for investigators to identify novel HFpEF subtypes and mechanisms (biological and pathophysiological) to inform future strategies for enhanced diagnosis and treatment of HFpEF.

Detailed description of study

HeartShare includes both an online registry using the Eureka platform in which participants will complete short monthly check-in surveys, and longer surveys every six months. Surveys may be completed via smartphone app or web browser on a desktop/laptop. No compensation is currently provided to registry participants.

Registry participants may also be asked to participate in an in-person deep phenotyping component which involves several non-invasive cardiac procedures that measure system function. These participants will have the option to complete muscle and adipose biopsies. Deep phenotyping participants will receive $500 for the baseline visit, and can receive an additional $125 for each biopsy procedure completed.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Medical Research
Age: Between 30 Years - 99 Years
Gender: All

Registry:

1. HF Group inclusion criteria (Registry)

- Age greater than or equal to 30 years

-Prior diagnosis of heart failure in an electronic health record (any left ventricular ejection fraction can be included)

2. Non-HF Group inclusion criteria (Registry)

-Age greater than or equal to 30 years

-No prior diagnosis of heart failure or use of loop diuretics

-No known prior history of BNP > 100pg/ml or NTproBNP >300pg/ml, if prior laboratory tests are available in the EHR

3. Exclusion criteria for Registry (both groups unless otherwise indicated)

-For non HF group, any prior known left ventricular ejection fraction less than 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

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:

a. 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.
b. 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).
c. 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).
d. Elevated H2FPEF score (≥5) or HFA-PEFF 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.

Exclusion Criteria (HeartShare Deep Phenotyping Cohort)

The following exclusion criteria apply to both HFpEF and non-HFpEF group participants, unless otherwise indicated.

1. Life expectancy estimated to be < 1 year.

2. 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).

3. 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).

4. Clinically significant valvular heart disease defined as:

a. Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis.
b. Any mitral stenosis.
c. Moderate or greater aortic regurgitation.
d. Greater than moderate mitral regurgitation.

5. Any planned cardiac surgery or cardiac intervention in the next 3 months.

6. Alternative primary reason for symptoms of shortness of breath and exercise

intolerance in HFpEF participants in the opinion of the enrolling investigator.

7. Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention,

stroke, transient ischemic attack, or carotid intervention in the preceding 6 months

prior to enrollment.

8. Known symptomatic epicardial coronary artery disease that is not revascularized.

9. Any non-elective hospitalization in the preceding 2 weeks.

10. Prior history of solid organ transplantation.

11. Prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator.

12. Prior history of mechanical circulatory support.

13. Prior history of non-cardiac cirrhosis.

14. Estimated GFR <20 ml/min/1.73m2 or currently on dialysis.

15. Any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator.

16. Inability to provide written consent to the study.

17. Current acute decompensated heart failure.

18. Currently pregnant.

19. Uncontrolled heart rate (>110 bpm) at the time of screening.

Online study

Updated on 09 Mar 2024. Study ID: 853478

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