Heartshare Heart Failure and Heart Failure With Preserved Ejection Fraction Registry

Overview

About this study

The purpose of this study is to establish both a heart failure (HF) registry and a heart failure with preserved ejection fraction (HFpEF) cohort with deep phenotyping and a biorepository to facilitate mechanistic studies and unbiased discovery approaches to HFpEF.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Open for enrollment

Contact information:

Janet Gatzke R.N.

(507) 538-7177

gatzke.janet@mayo.edu

More information

Publications

Publications are currently not available