Cardiac MRI-Derived Pressure-Volume Loop Analysis in Heart Failure With Preserved Ejection Fraction (CMR-PV HFpEF)

Discriminative and Prognostic Value of Myocardial Energetics and Pressure-Volume Loop Parameters Derived From Cardiac MRI in Heart Failure With Preserved Ejection Fraction

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure With Preserved Ejection Fraction (HFPEF)

• Study Type: Observational
• Enrollment (Estimated): 5500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure with preserved ejection fraction experienced cardiac MRI scanning

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HFpEF patients; Heart failure with preserved ejection fraction (HFpEF) patients
Healthy controls; Sex- and age-matched healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with All-Cause Death	All-cause death was defined as death from any cause occurring during the 3-year follow-up period. Mortality status was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Cardiovascular Death	Cardiovascular death was defined as death resulting from cardiovascular causes occurring during the 3-year follow-up period. Cardiovascular causes included, but were not limited to, myocardial infarction, heart failure, fatal arrhythmia, stroke, or sudden cardiac death. The outcome was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.	3-year
Number of Participants with Heart Failure Hospitalization	Heart failure hospitalization was defined as any hospitalization for heart failure occurring during the 3-year follow-up period. Hospitalizations were identified based on hospital admission records with a primary diagnosis of heart failure.	3-year

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac MRI; Heart failure with preserved ejection fraction; Pressure loop analysis
• Other Study ID Numbers: CMR-PV HFpEF; 82471973 (Other Grant/Funding Number: National Natural Science Foundation of China); 7242110 (Other Grant/Funding Number: Beijing Natural Science Foundation); 3332025134 (Other Grant/Funding Number: Fundamental Research Funds for the Central Universities)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No