Heart Failure With Preserved Ejection Fraction and Its Cardiac MR Characteristics of Different Subtypes
NCT ID: NCT06916611
Last Updated: 2025-04-08
Study Results
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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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2023-05-01
2026-12-31
Brief Summary
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Detailed Description
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To identify distinct cardiac magnetic resonance (CMR) features associated with HFpEF and its comorbidity subtypes.
To evaluate prognostic differences (mortality, heart failure readmission, healthcare costs) across HFpEF subtypes.
2. Study Design Type: Single-center, prospective, observational cohort study. Duration: April 1, 2023 - December 31, 2026. Sample Size: 500 HFpEF patients, with \~200 patients per subgroup.
3. Data Collection Framework
Baseline Data:
Clinical Parameters:
Demographics (age, gender, BMI). Comorbidities (hypertension, diabetes, renal function). Biochemical markers (BNP/NT-proBNP, HbA1c, lipid profile, renal function). Medications (ACE inhibitors, beta-blockers, diuretics).
Imaging Data:
Echocardiography: Left ventricular ejection fraction (LVEF ≥50%). CMR: Ventricular volumes, mass, strain analysis, T1 mapping, and late gadolinium enhancement (LGE).
Follow-Up Protocol:
Frequency: Every 6 months post-discharge.
Endpoints:
Primary: Cardiovascular mortality, HF-related readmission. Secondary: Changes in CMR parameters, medication adjustments, healthcare utilization.
4. Subgroup Classification
Comorbidity Subgroups:
HFpEF + Hypertension. HFpEF + Type 2 Diabetes. HFpEF + Renal Insufficiency. HFpEF + Obesity. Control Group: HFpEF patients without the above comorbidities.
5. CMR Protocol
Imaging Sequences:
Cine imaging for ventricular function. T1 mapping for myocardial fibrosis assessment. LGE for scar detection. Post-Processing: Analysis of myocardial strain, extracellular volume (ECV), and perfusion reserve.
6. Statistical Analysis
Methods:
Regression analysis for associations between CMR features and clinical outcomes.
Survival analysis (Kaplan-Meier, Cox proportional hazards models). Subgroup comparisons using ANOVA or non-parametric tests. Software: SPSS 20.0 (significance threshold: p \<0.05).
7. Ethical and Data Management Privacy Protection: De-identified data storage with restricted access. Data Validation: Double-entry verification for 10% of randomly selected cases. Compliance: Adherence to institutional review board (IRB) guidelines and GCP standards.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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).
Cardiac Magnetic Resonance Imaging
This study included patients who were diagnosed with HFpEF and had completed CMR.
Interventions
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Cardiac Magnetic Resonance Imaging
This study included patients who were diagnosed with HFpEF and had completed CMR.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Severe valvular heart disease (severe, severe severe) or known infiltrative or hypertrophic cardiomyopathy
* Malignant tumors and severe hematological diseases
* severe infection
* Autoimmune system diseases
50 Years
ALL
No
Sponsors
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The Affiliated Hospital of Xuzhou Medical University
OTHER
Responsible Party
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Locations
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the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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Other Identifiers
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XYFY2023-KL187-01
Identifier Type: -
Identifier Source: org_study_id
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