Myocardial Mechanisms in HFpEF

Overview

About this study

The purpose of this study is to identify altered biological pathways regulating cardiac structure and function in patients with Heart Failure with Preserved Ejection Fraction (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.

Inclusion Criteria:

HFpEF criteria

  • Age ≥ 30 years.
  • Left ventricular ejection fraction ≥ 50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability).
  • Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:
    • 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;
    • 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);
    • Previously documented 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 score69 (≥5) or HFA-PEFF70 score (≥ 5).

Suspected HFpEF criteria

  • Age ≥ 30 years.
  • Left ventricular ejection fraction ≥ 50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
  • Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:
    • Does not meet BNP or NT-proBNP criteria for HFpEF (above);
    • No prior HF hospitalization meeting HF criteria (above);
    • No previous hemodynamic catheterization documentation of HF (as above).

Exclusion Criteria:

  • Inadequate echo or fluoroscopic images.
  • Neck anatomy unfavorable for jugular venous cannulation.
  • Therapy with direct oral anticoagulants without cessation for a period (age, renal function, and agent specific) deemed adequate to normalize coagulation according to local clinical guidelines.
  • Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB.
  • Platelet count < 50,000/ml.
  • Active bleeding or coagulation disorder.
  • Infection or fever.
  • Endocarditis.
  • Pregnancy.
  • Intracardiac thrombus.
  • RV Aneurysm.
  • Clinically significant tricuspid, pulmonary or aortic valve stenosis.
  • Tricuspid or pulmonary mechanical valve prosthesis.
  • Left bundle branch block.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/18/24. 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

Margaret Redfield, M.D.

Open for enrollment

Contact information:

Brendon Urena

(507) 538-8305

Urena.Brendon@mayo.edu

More information

Publications

Publications are currently not available