Heart Failure With Preserved Ejection Fraction and Its Cardiac MR Characteristics of Different Subtypes

Last updated: April 1, 2025
Sponsor: The Affiliated Hospital of Xuzhou Medical University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Hyponatremia

Treatment

Cardiac Magnetic Resonance Imaging

Clinical Study ID

NCT06916611
XYFY2023-KL187-01
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 duringhospitalization / visit (BNP 100 pg/mL or NT-proBNP 400 pg / mL).

Exclusion

Exclusion Criteria:

  • Severe liver and kidney insufficiency

  • Severe valvular heart disease (severe, severe severe) or known infiltrative orhypertrophic cardiomyopathy

  • Malignant tumors and severe hematological diseases

  • severe infection

  • Autoimmune system diseases

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Cardiac Magnetic Resonance Imaging
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
December 31, 2026

Study Description

  1. Study Objectives To compare clinical characteristics among HFpEF patients with different comorbidity subtypes (hypertension, type 2 diabetes, renal insufficiency, obesity).

    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.

Connect with a study center

  • the Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

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