HFpEFNCT06916611
Heart Failure With Preserved Ejection Fraction and Its Cardiac MR Characteristics of Different Subtypes
An observational study of HFpEF and Heart Failure With Preserved Ejection Fraction, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HFpEF, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Cardiac Magnetic Resonance Imaging
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- Subgroup Classification Comorbidity Subgroups: HFpEF + Hypertension. HFpEF + Type 2 Diabetes. HFpEF + Renal Insufficiency. HFpEF + Obesity. Control Group: HFpEF patients without the above comorbidities.
- 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.
- 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).
- 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.
- Being tested
- Cardiac Magnetic Resonance Imaging
- Keywords
- Heart Failure with Preserved Ejection Fraction，HFpEF, Cardiac Magnetic Resonance Imaging，CMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingOther
This study included patients who were diagnosed with HFpEF and had completed CMR.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cardiac Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cardiovascular death
Measured: follow - up every 6 months; up to 24 - months
Rate of readmission of heart failure
Measured: follow - up every 6 months; up to 24 - months
Secondary outcomes (6)
Body Temperature
Measure body temperature every morning on an empty stomach using an electronic thermometer, with the unit being degrees Celsius (℃)
Measured: 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.
Measured: Baseline
Brain Natriuretic Peptide (BNP)
Detect BNP levels using an electrochemiluminescence immunoassay analyzer, with the unit being picograms per milliliter (pg/mL).
Measured: Baseline
Glycated Hemoglobin (HbA1c)
Detect glycated hemoglobin using high - performance liquid chromatography, and the result is expressed as a percentage (%).
Measured: 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)
Measured: Baseline
Heart Rate
Continuously monitor the heart rate using an electrocardiogram monitor, with the unit being beats per minute (bpm).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916611
- Sponsor's protocol ID
- XYFY2023-KL187-01
- Status last verified
- Apr 2025
- First submitted
- 20 Jan 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering the patient's privacy and the next steps in our research program
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure With Preserved Ejection Fraction and Its Cardiac MR Characteristics of Different Subtypes
- ClinicalTrials.gov ID
- NCT06916611
- Acronym / sponsor ID
- XYFY2023-KL187-01
- Keywords
- Heart Failure with Preserved Ejection Fraction，HFpEF, Cardiac Magnetic Resonance Imaging，CMR
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- Subgroup Classification Comorbidity Subgroups: HFpEF + Hypertension. HFpEF + Type 2 Diabetes. HFpEF + Renal Insufficiency. HFpEF + Obesity. Control Group: HFpEF patients without the above comorbidities.
- 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.
- 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).
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with HFpEF | – | Other: Cardiac Magnetic Resonance ImagingDiagnostic 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance ImagingThis study included patients who were diagnosed with HFpEF and had completed CMR. | Other | Patients diagnosed with HFpEF |
Primary outcome
Rate of Cardiovascular death
Time frame: follow - up every 6 months; up to 24 - months
Rate of readmission of heart failure
Time frame: follow - up every 6 months; up to 24 - months
6 secondary outcomes
Body Temperature
Time frame: Baseline
Blood Glucose Levels
Time frame: Baseline
Brain Natriuretic Peptide (BNP)
Time frame: Baseline
Glycated Hemoglobin (HbA1c)
Time frame: Baseline
Blood Pressure
Time frame: Baseline
Heart Rate
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No. Considering the patient's privacy and the next steps in our research program
Related trials for HFpEF
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HFpEF and Heart Failure With Preserved Ejection Fraction, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Cardiovascular death (time frame: follow - up every 6 months; up to 24 - months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.