RECRUITING

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

Conditions

Heart Failure Heart Failure With Preserved Ejection Fraction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study

Quick Facts

Study Start:2024-11-08

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06517186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). 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)	* 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

Inclusion Criteria

Exclusion 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).
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)

* 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

Contacts and Locations

Study Contact

Laura Alagna

CONTACT

312-695-6765

heartsharestudy@northwestern.edu

Principal Investigator

Sanjiv Shah, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Margaret Redfield, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Mass General Brigham

Boston, Massachusetts, 02114

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Wake Forest University

Winston-Salem, North Carolina, 27157

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Northwestern University

Sanjiv Shah, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
Margaret Redfield, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-08

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-11-08

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure
Heart Failure With Preserved Ejection Fraction