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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction; HFpEF
• Intervention / Treatment: Other: Cardiac Magnetic Resonance Imaging

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; This study included patients who were diagnosed with HFpEF and had completed CMR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Body Temperature	Measure body temperature every morning on an empty stomach using an electronic thermometer, with the unit being degrees Celsius (℃)	Baseline
Blood Glucose Levels	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.	Baseline
Brain Natriuretic Peptide (BNP)	Detect BNP levels using an electrochemiluminescence immunoassay analyzer, with the unit being picograms per milliliter (pg/mL).	Baseline
Glycated Hemoglobin (HbA1c)	Detect glycated hemoglobin using high - performance liquid chromatography, and the result is expressed as a percentage (%).	Baseline
Blood Pressure	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)	Baseline
Heart Rate	Continuously monitor the heart rate using an electrocardiogram monitor, with the unit being beats per minute (bpm).	Baseline

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure with Preserved Ejection Fraction，HFpEF; Cardiac Magnetic Resonance Imaging，CMR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: XYFY2023-KL187-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Considering the patient's privacy and the next steps in our research program

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No