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

NCT07326605 | Enrolling By Invitation DMC

• 4 other identifiers: CMR-PV HFpEF8247197372421103332025134
• Study Type: observational
• Target: 5,500
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Cardiac MRI; Heart failure with preserved ejection fraction; Pressure loop analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants with Cardiovascular Death

  3-year

• Number of Participants with Heart Failure Hospitalization

  3-year

Study Arms (2)

HFpEF patients

Heart failure with preserved ejection fraction (HFpEF) patients

Healthy controls

Sex- and age-matched healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2010
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: January 28, 2026

Record last verified: 2025-12