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

NCT07336316 | Enrolling By Invitation DMC

• 1 other identifier: CMR-CMHF
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes (DM); Hypertension; Heart Failure; Obesity & Overweight

Outcome Measures

Primary Outcomes (2)

• Incidence Rate of all cause or cardiovascular death

  2-15 years

• Incidence Rate of HF hospitalization

  HF hospitalization was defined as an unplanned hospitalization with documented clinical and radiological evidence for HF and need for diuretic treatment

  2-15 years

Other Outcomes (1)

• Incidence Rate of newly onset heart failure

  2-15 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

early-stage heart faliure with cardiovascular risk factors

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Related Publications (4)

• 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.

  PMID: 30732715 RESULT

• 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.

  PMID: 34729586 RESULT

• 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.

  PMID: 28381470 RESULT

• 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.

  PMID: 40742364 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Heart Failure; Obesity; Overweight

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Magnetic Resonance Imaging

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2010
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 23, 2026

Record last verified: 2025-05