Identifying heart tissue changes in patients with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the structural and functional changes in heart tissue of patients diagnosed with heart failure with preserved ejection fraction (HFpEF). By performing endomyocardial biopsies during right heart catheterizations, researchers will gather critical data to understand the underlying mechanisms of HFpEF. The ultimate goal is to leverage these insights to develop new therapeutic strategies for managing heart failure. The study will include patients who meet specific criteria related to heart function and symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* HFpEF criteria

  1. Age ≥30 years.
  2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
  3. Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:

     1. 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.
     2. 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).
     3. 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).
     4. Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5).

Suspected HFpEF criteria

1. Age ≥30 years.
2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
3. Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:

   1. Does not meet BNP or NT-proBNP criteria for HFpEF (above)
   2. No prior HF hospitalization meeting HF criteria (above)
   3. No previous hemodynamic catheterization documentation of HF (as above)

Exclusion Criteria:

* 1\. Inadequate echo or fluoroscopic images.

  2\. Neck anatomy unfavorable for jugular venous cannulation

  3\. 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.

  4\. Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB

  5\. Platelet count \< 50,000/ml

  6\. Active bleeding or coagulation disorder

  7\. Infection or fever

  8\. Endocarditis

  9\. Pregnancy

  10\. Intracardiac thrombus

  11\. RV Aneurysm

  12\. Clinically significant tricuspid, pulmonary or aortic valve stenosis

  13\. Tricuspid or pulmonary mechanical valve prosthesis

  14\. Left bundle branch block

Where it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Mass General Brigham
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Wake Forest University
  Winston-Salem, North Carolina, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Sanjiv Shah, MD — Northwestern University
• Study coordinator: Laura Alagna
• Email: heartsharestudy@northwestern.edu
• Phone: 312-695-6765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.