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Diabetes (DM)NCT07336316

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

An observational study of Diabetes (DM) and Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Diabetes (DM), Hypertension, Heart Failure
How many people
3,000 participants
Where
No sites listed yet
Study dates
1 Jan 2010to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: early-stage heart faliure with cardiovascular risk factors

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Infiltrative cardiomyopathy (e.g., cardiac amyloidosis)
  • Congenital heart disease
  • Poor image quality insufficient for delineating the endocardium and epicardium

About this study

Official title: Multimodal Cardiovascular Magnetic Resonance Imaging for Cardiometabolic Pre-HF and HFpEF: Integrated Phenotyping, Precision Diagnosis, and Risk Stratification

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.

Read the detailed description

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.

Medical subject headings
Diabetes Mellitus, Hypertension, Heart Failure, Obesity, Overweight

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Rate of all cause or cardiovascular death

    Measured: 2-15 years

  2. 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

    Measured: 2-15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start1 Jan 2010
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336316
Sponsor's protocol ID
CMR-CMHF
Status last verified
May 2025
First submitted
3 Jan 2026
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30732715

  • 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.

    PubMed 34729586

  • 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.

    PubMed 28381470

  • 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.

    PubMed 40742364

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes (DM) and Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of all cause or cardiovascular death (time frame: 2-15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07336316, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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