Identifying heart tissue changes in patients with heart failure
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study
This study looks at changes in heart tissue of people with heart failure to see if it can help find better treatments for their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 6 sites (Chicago, Illinois and 5 other locations) |
| Trial ID | NCT06517186 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 30 and older with a left ventricular ejection fraction of 50% or higher and symptoms consistent with heart failure.
Not a fit: Patients with heart failure who do not meet the specific criteria for preserved ejection fraction or those with other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of innovative treatments for heart failure with preserved ejection fraction.
How similar studies have performed: Other studies investigating heart tissue changes in heart failure have shown promise, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.