Heart Failure With Preserved Ejection Fraction, HFpEF
Conditions
Keywords
Heart Failure with Preserved Ejection Fraction，HFpEF, Cardiac Magnetic Resonance Imaging，CMR
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.
Interventions
OTHERCardiac Magnetic Resonance Imaging
This study included patients who were diagnosed with HFpEF and had completed CMR.
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (%). |
| Body Temperature | Baseline | Measure body temperature every morning on an empty stomach using an electronic thermometer, with the unit being degrees Celsius (℃) |
| Heart Rate | Baseline | Continuously monitor the heart rate using an electrocardiogram monitor, with the unit being beats per minute (bpm). |
| 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) |
| 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. |
Countries
China
Outcome results
None listed