Multimodal Cardiovascular Magnetic Resonance Imaging for Cardiometabolic Pre-HF and HFpEF

NCT ID: NCT07336316

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2030-12-31

Brief Summary

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This is an observational study aiming to characterize the pathophysiological features and clinical significance of cardiometabolic early-stage heart failure using advanced multimodal cardiovascular magnetic resonance (CMR) imaging. The study will focus on patients with cardiometabolic risk factors such as diabetes, hypertension, and obesity who are in the pre-heart failure (pre-HF) stage or have heart failure with preserved ejection fraction (HFpEF). The study seeks to establish a full-chain imaging framework-from precise phenotypic classification and sensitive noninvasive diagnosis to individualized cardiovascular risk stratification. Participants will undergo multimodal CMR scans and comprehensive clinical evaluations and be followed up for primary outcome.

Detailed Description

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Advanced noninvasive multimodal cardiovascular magnetic resonance (CMR) imaging techniques-including early functional impairment detection (feature tracking), myocardial tissue characterization (T1 mapping), hemodynamic changes (hemodynamic force \[HDF\] analysis), and magnetic resonance spectroscopy-have significant potential clinical value, especially for capturing the complex pathophysiology of cardiometabolic early-stage heart failure.

This study applies these advanced CMR imaging techniques to individuals with cardiometabolic risk factors and early-stage heart failure (pre-HF and HFpEF) to perform multidimensional, comprehensive CMR analyses. The goal is to identify characteristic imaging patterns for this cohort, develop targeted diagnostic models, facilitate their application in risk prediction and individualized management, and ultimately establish an imaging evaluation framework that can optimize clinical pathways for cardiometabolic pre-HF and HFpEF.

This study enrolls patients undergoing CMR who have early-stage cardiometabolic heart failure (pre-HF and HFpEF), including with diabetes, hypertension, obesity and so on. Clinical data, laboratory results, and echocardiographic parameters will be collected.

Through cross-sectional analysis, the study will evaluate chamber structure and function, myocardial tissue characteristics, hemodynamics, and myocardial energy metabolism, and summarize characteristic imaging phenotypes of cardiometabolic early-stage heart failure. Imaging parameters will be compared to identify robust noninvasive diagnostic markers and optimize the diagnostic framework for cardiometabolic early-stage heart failure. In addition, participants will be followed longitudinally to collect outcome events. The predictive value of CMR-derived indicators for clinical outcomes will be analyzed, and risk prediction models will be developed to achieve precise risk stratification for patients with early-stage cardiometabolic heart failure.

Conditions

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Diabetes (DM) Hypertension Heart Failure Obesity & Overweight

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Left ventricular ejection fraction (LVEF) ≥ 50%;
* Presence of cardiovascular risk factors, including, but not limited to, the following: diabetes mellitus, hypertension, obesity.

Exclusion Criteria

* Primary cardiomyopathy (e.g., hypertrophic, dilated, and restrictive cardiomyopathy)
* Acute coronary syndrome in the previous 30 days
* More than moderate valvular disease
* Restrictive pericardial disease
* Severe arrhythmia
* Heart tumors
* Infiltrative cardiomyopathy (e.g., cardiac amyloidosis)
* Congenital heart disease
* Poor image quality insufficient for delineating the endocardium and epicardium
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Minjie Lu

Director of Magnetic Resonance Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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McHugh K, DeVore AD, Wu J, Matsouaka RA, Fonarow GC, Heidenreich PA, Yancy CW, Green JB, Altman N, Hernandez AF. Heart Failure With Preserved Ejection Fraction and Diabetes: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Feb 12;73(5):602-611. doi: 10.1016/j.jacc.2018.11.033.

Reference Type RESULT
PMID: 30732715 (View on PubMed)

Smiseth OA, Morris DA, Cardim N, Cikes M, Delgado V, Donal E, Flachskampf FA, Galderisi M, Gerber BL, Gimelli A, Klein AL, Knuuti J, Lancellotti P, Mascherbauer J, Milicic D, Seferovic P, Solomon S, Edvardsen T, Popescu BA; Reviewers: This document was reviewed by members of the 2018-2020 EACVI Scientific Documents Committee. Multimodality imaging in patients with heart failure and preserved ejection fraction: an expert consensus document of the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2022 Jan 24;23(2):e34-e61. doi: 10.1093/ehjci/jeab154.

Reference Type RESULT
PMID: 34729586 (View on PubMed)

Obokata M, Reddy YNV, Pislaru SV, Melenovsky V, Borlaug BA. Evidence Supporting the Existence of a Distinct Obese Phenotype of Heart Failure With Preserved Ejection Fraction. Circulation. 2017 Jul 4;136(1):6-19. doi: 10.1161/CIRCULATIONAHA.116.026807. Epub 2017 Apr 5.

Reference Type RESULT
PMID: 28381470 (View on PubMed)

Daou D, Tong D, Schiattarella GG, Gillette TG, Hill JA. What Is Cardiometabolic HFpEF and How Can We Study it Preclinically? JACC Basic Transl Sci. 2025 Oct;10(10):101295. doi: 10.1016/j.jacbts.2025.04.009. Epub 2025 Jul 30.

Reference Type RESULT
PMID: 40742364 (View on PubMed)

Other Identifiers

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CMR-CMHF

Identifier Type: -

Identifier Source: org_study_id

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