NCT06916611

Brief Summary

Using cardiac magnetic resonance imaging technology, the ejection fraction of heart failure (HFpEF) and different subtypes of cardiac magnetic resonance characteristics, and combined with the clinical characteristics and prognosis of the patient, explore the value of cardiac magnetic resonance in disease diagnosis, classification, treatment and prognosis, and provide new ideas for clinical practice.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
May 2023Dec 2026

Study Start

First participant enrolled

May 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3.7 years

First QC Date

January 20, 2025

Last Update Submit

April 1, 2025

Conditions

Keywords

Heart Failure with Preserved Ejection Fraction,HFpEFCardiac Magnetic Resonance Imaging,CMR

Outcome Measures

Primary Outcomes (2)

  • Rate of Cardiovascular death

    follow - up every 6 months; up to 24 - months

  • Rate of readmission of heart failure

    follow - up every 6 months; up to 24 - months

Secondary Outcomes (6)

  • Body Temperature

    Baseline

  • Blood Glucose Levels

    Baseline

  • Brain Natriuretic Peptide (BNP)

    Baseline

  • Glycated Hemoglobin (HbA1c)

    Baseline

  • Blood Pressure

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Patients diagnosed with HFpEF

Diagnostic criteria for HFpEF: * Age = 50 years old ② Cardiac color ultrasound EF 50% ③ Symptoms / signs of heart failure and increased natriuretic peptide levels during hospitalization / visit (BNP 100 pg/mL or NT-proBNP 400 pg / mL).

Other: Cardiac Magnetic Resonance Imaging

Interventions

This study included patients who were diagnosed with HFpEF and had completed CMR.

Patients diagnosed with HFpEF

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the patients who were diagnosed with "cardiac insufficiency / heart failure" from April 1,2023 to December 31,2026, the medical records were retrieved and the enrolled patients were determined according to the enrollment criteria and the exclusion criteria. Subgroup selection: ① HFpEF combined with hypertension * HFpEF is complicated with type 2 diabetes mellitus ③ HFpEF combined with renal insufficiency ④ HFpEF combined with obesity Control group: ①HFpEF patients

You may qualify if:

  • Age is 50 years old.
  • Cardiac color ultrasound shows an ejection fraction (EF) of 50% or more.
  • Symptoms / signs of heart failure and increased natriuretic peptide levels during hospitalization / visit (BNP 100 pg/mL or NT-proBNP 400 pg / mL).

You may not qualify if:

  • Severe liver and kidney insufficiency
  • Severe valvular heart disease (severe, severe severe) or known infiltrative or hypertrophic cardiomyopathy
  • Malignant tumors and severe hematological diseases
  • severe infection
  • Autoimmune system diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

April 8, 2025

Study Start

May 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Considering the patient's privacy and the next steps in our research program

Locations