Cardiac MRI-Derived Pressure-Volume Loop Analysis in Heart Failure With Preserved Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction (HFPEF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Discriminative and Prognostic Value of Myocardial Energetics and Pressure-Volume Loop Parameters Derived From Cardiac MRI in Heart Failure With Preserved Ejection Fraction
Overview
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.
Primary outcome measures
- Number of Participants with All-Cause Death [Time frame: 3-year]
Secondary outcome measures (2)
- Number of Participants with Cardiovascular Death [Time frame: 3-year]
- Number of Participants with Heart Failure Hospitalization [Time frame: 3-year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07326605 · CMR-PV HFpEF · 82471973 · 7242110 · 3332025134