Recruiting

Heart Failure

Sponsor:

Northwestern University

Code:

NCT06517186

Conditions

Heart Failure

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.

Conditions

Heart Failure

Heart Failure With Preserved Ejection Fraction

Study ID

NCT06517186

Start date

Nov 8, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

HFpEF

Participants with HFpEF

Non-HFpEF

Participants without HFpEF

Primary outcome measure

  • Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Sadiya Khan, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Matt Kauffman

mkkauffman@jhmi.edu

Principal Investigator:

Kavita Sharma, MD

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Greg Lewis, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Margaret Redfield, MD

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Ben Nelson

336-716-6789

Principal Investigator:

Dalane Kitzman, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Tiffany Sharkoski

215-615-2354

Principal Investigator:

Julio Chirinos, MD, PhD

More Information

Sponsor

Northwestern University

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-04-09.