Cardiac MRI-Derived Pressure-Volume Loop Analysis in Heart Failure With Preserved Ejection Fraction

NCT ID: NCT07326605

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 5500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2030-12-30

Brief Summary

This is a multi-center, observational study designed to evaluate the discriminative and prognostic value of pressure-volume (PV) loop analysis parameters and myocardial energetics derived from cardiac MRI in patients with heart failure with preserved ejection fraction (HFpEF). This study plans to enroll 3000 adult HFpEF patients and 500 adult healthy controls. The primary clinical endpoint was a composite of all-cause mortality and heart failure hospitalization, with events ascertained through medical records, clinic visits, and telephone follow-up. This study aims to determine whether cardiac MRI-derived PV loop analysis parameters and myocardial energetics provide incremental discriminative and prognostic information beyond conventional cardiac MRI parameters in patients with HFpEF. The study is non-interventional and does not involve any investigational drugs or devices.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

HFpEF patients

Heart failure with preserved ejection fraction (HFpEF) patients

No interventions assigned to this group

Healthy controls

Sex- and age-matched healthy controls

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Symptoms and/or signs of HF ≥ New York Heart Association (NYHA) class II;

2. Left ventricular ejection fraction (LVEF) of 50% or higher;

3. N-terminal fragment of the prohormone of brain natriuretic peptide (NT-proBNP) level > 125 pg/mL or brain natriuretic peptide (BNP) level > 35 pg/mL in sinus rhythm, or NT-proBNP level > 365 pg/mL or BNP level > 105 pg/mL in atrial fibrillation;

4. At least one of objective indicators of (i) cardiac structural abnormalities including LA maximum volume index (LAVi max) > 29 mL/m2 or echocardiography-measured LV end-diastolic mass index (LVMi) ≥ 115 g/m2 for men and ≥ 95 g/m2 for women, and (ii) LV diastolic dysfunction including early and/or late diastolic mitral inflow velocity (E/A) < 1 or early diastolic mitral inflow velocity and/or mitral annular peak early diastolic velocity (E/e') > 13.

Exclusion Criteria

1. Primary cardiomyopathy;

2. Acute coronary syndrome;

3. Primary severe valvular heart disease;

4. Acute pulmonary embolism;

5. Severe renal dysfunction;

6. Poor image quality that was insufficient to identify myocardial endocardium and epicardium.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Minjie Lu

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

82471973

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

7242110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

3332025134

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CMR-PV HFpEF

Identifier Type: -

Identifier Source: org_study_id