Ensayos clínicos

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.

Exclusion Criteria (HeartShare Registry):

• 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.

HFpEF Inclusion for the 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 (> 100 pg/ml in sinus rhythm or > 300 pg/ml in atrial fibrillation/flutter) or NTproBNP (> 300 pg/ml in sinus rhythm or > 900 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 > 100 pg/ml or NTproBNP > 300 pg/ml, if prior laboratory tests are available in the EHR.
• BNP < 100 pg/ml or NTproBNP < 300 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):

• 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/1.73m^2 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.
• Uncontrolled heart rate (> 110 bpm) at time of screening.

Eligibility last updated 5/3/23. Questions regarding updates should be directed to the study team contact.