Cardiac MRI-Derived Pressure-Volume Loop Analysis 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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Symptoms and/or signs of HF ≥ New York Heart Association (NYHA) class II;
Left ventricular ejection fraction (LVEF) of 50% or higher;
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;
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

Primary cardiomyopathy;
Acute coronary syndrome;
Primary severe valvular heart disease;
Acute pulmonary embolism;
Severe renal dysfunction;
Poor image quality that was insufficient to identify myocardial endocardium and epicardium.

Treatment and study plan

Primary outcomes

Number of Participants with All-Cause Death

Time frame: 3-year

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.

Secondary outcomes

Number of Participants with Cardiovascular Death

Time frame: 3-year

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.
Number of Participants with Heart Failure Hospitalization

Time frame: 3-year

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.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Acronym: CMR-PV HFpEF

Important dates

Study start: 2010
Primary completion: 2028
Study completion: 2030
First posted: Jan 8, 2026
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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