NCT07326605Enrolling by invitation
Cardiac MRI-Derived Pressure-Volume Loop Analysis in Heart Failure With Preserved Ejection Fraction
Discriminative and Prognostic Value of Myocardial Energetics and Pressure-Volume Loop Parameters Derived From Cardiac MRI in Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 5500 (estimated)
- First submitted
- 24 Dec 2025
- Start date
- 1 Jan 2010
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Diseases
- Heart failure
- NCT number
- NCT07326605
What you commit to
- Study type: Observational
- Planned participants: 5500
- From 1 Jan 2010 to the primary completion date, 30 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute coronary syndrome;
- Primary severe valvular heart disease;
- Poor image quality that was insufficient to identify myocardial endocardium and epicardium.
Other
- Primary cardiomyopathy;
- Acute pulmonary embolism;
- Severe renal dysfunction;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.