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

Active, not recruiting

• Conditions: HFpEF; Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT06916611
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

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.

Detailed 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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2025-01-20
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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 during hospitalization / visit (BNP 100 pg/mL or NT-proBNP 400 pg / mL).

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Body Temperature	Baseline	Measure body temperature every morning on an empty stomach using an electronic thermometer, with the unit being degrees Celsius (℃)
Blood Glucose Levels	Baseline	Draw blood on an empty stomach in the morning and detect fasting blood glucose using a biochemical analyzer, with the unit being mmol/L; measure 2 - hour post - prandial blood glucose using a portable blood glucose meter, with the unit being mmol/L.
Brain Natriuretic Peptide (BNP)	Baseline	Detect BNP levels using an electrochemiluminescence immunoassay analyzer, with the unit being picograms per milliliter (pg/mL).
Glycated Hemoglobin (HbA1c)	Baseline	Detect glycated hemoglobin using high - performance liquid chromatography, and the result is expressed as a percentage (%).
Blood Pressure	Baseline	Measure blood pressure once in the morning and once in the evening every day using a blood pressure monitor, with the unit being millimeters of mercury (mmHg)
Heart Rate	Baseline	Continuously monitor the heart rate using an electrocardiogram monitor, with the unit being beats per minute (bpm).

Trial Locations

Locations (1)

the Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China