Heart Failure With Preserved Ejection FractionRIPE-HFNCT06487468
Risk Factors In Heart Failure Patients With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction, run by Xiangtan Central Hospital.
Trial summary
This study aimed to identify the independent risk factors associated with heart failure readmission, cardiac mortality and all-cause death among patients discharged from Xiangtan Central Hospital with heart failure and preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- How many people
- 9,419 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who hospitalized the Xiangtan Central Hospital between May 1, 2014, and January 31, 2023, with the diagnosis of heart failure and met HFpEF criteria at final analysis.
Who may be able to join
- Patients discharged with diagnosis of heart failure were screened and met definition of heart failure with preserved ejection fraction (HFpEF) according to the 2021 European Society of Cardiology (ESC) guidelines at final analysis.
- 1）Heart failure signs and symptoms; 2）LVEF>50%;
Who cannot join
- 1) age under 18 years; 2) life expectancy of less than one year due to non-cardiac conditions.
About this study
Official title: A Study on Risk Factors in Heart Failure Patients With Preserved Ejection Fraction After Hospital Discharge
This study aimed to identify the independent risk factors associated with heart failure readmission, cardiac mortality and all-cause death among patients discharged from Xiangtan Central Hospital with heart failure and preserved ejection fraction (HFpEF). Understanding related risk factors might add future clinical decision making for individualized post discharge management of HFpEF patients aiming to improve the outcome of discharged HFpEF patients.
Read the detailed description
This study sought to determine the independent risk factors linked to endpoint events (which include all-cause mortality or readmission for heart failure, cardiovascular death) among hospitalized patients with heart failure and preserved ejection fraction (HFpEF) at Xiangtan Central Hospital during the period from May 1, 2014, to January 31, 2023. The clinical follow up ended on January 31, 2024. The study examined the risk factors associated with the endpoint outcome (cardiovascular death and death from any cause and readmission due to heart failure) to provide clinical evidence for intervening discharged HFpEF patients, with the objective of improving patient outcomes in future clinical practice.
The clinical features of hospitalized heart failure with preserved ejection fraction (HFpEF, EF≥50%) are analyzed retrospectively by reviewing the patient's demographic, clinical data, including patient medical history, initial clinical evaluations, and therapeutic interventions, as well as echocardiographic data in the hospital's electronic health records and relevant databases. The clinical outcome of enrolled patients are obtained through a team of three experienced cardiologists and twelve nursing professionals through outpatient consultations, telephone follow-ups, and community visit. The primary endpoint events are all-cause mortality, the second endpoints are the composite cardiovascular death and heart failure readmission.
- Keywords
- HFpEF, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF Group | HFpEF (Heart failure with preserved ejection fraction): LVEF≥50%. Non-endpoint events group versus Endpoint events (all-cause death,cardiovascular death or heart failure readmission) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death（people）
Risk factors of all-cause death are analyzed（Increase the factors that contribute to the occurrence of endpoint events）
Measured: The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.
Secondary outcomes (1)
Cardiovascular death and Heart failure readmission（people）
The risk factors related to cardiovascular death and heart failure readmission post discharge are analyzed.（Increase the factors that contribute to the occurrence of endpoint events）
Measured: The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 May 2014
- Primary completion31 Jan 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangtan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping Zeng, Xiangtan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487468
- Sponsor's protocol ID
- 2024/6
- Acronym
- RIPE-HF
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu Y, Zhao W, Liu Z, Tan D, Tao L, He W, Jiang K, Huang H, Wu M, Tang L, Zeng J, Zhou S. Development and validation of a prediction model for all-cause death in heart failure patients with preserved ejection fraction: a single-centre cohort study in China. BMJ Open. 2025 Sep 10;15(9):e094909. doi: 10.1136/bmjopen-2024-094909.
PubMed 40935414
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Risk Factors in Heart Failure Patients With Preserved Ejection Fraction After Hospital Discharge
- ClinicalTrials.gov ID
- NCT06487468
- Acronym / sponsor ID
- RIPE-HF / 2024/6
- Keywords
- HFpEF, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,419 participants (actual)
- Lead sponsor
- Xiangtan Central HospitalUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 5 Jul 2024 (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.
This study aimed to identify the independent risk factors associated with heart failure readmission, cardiac mortality and all-cause death among patients discharged from Xiangtan Central Hospital with heart failure and preserved ejection fraction (HFpEF). Understanding related risk factors might add future clinical decision making for individualized post discharge management of HFpEF patients aiming to improve the outcome of discharged HFpEF patients.
Detailed description
This study sought to determine the independent risk factors linked to endpoint events (which include all-cause mortality or readmission for heart failure, cardiovascular death) among hospitalized patients with heart failure and preserved ejection fraction (HFpEF) at Xiangtan Central Hospital during the period from May 1, 2014, to January 31, 2023. The clinical follow up ended on January 31, 2024. The study examined the risk factors associated with the endpoint outcome (cardiovascular death and death from any cause and readmission due to heart failure) to provide clinical evidence for intervening discharged HFpEF patients, with the objective of improving patient outcomes in future clinical practice.
The clinical features of hospitalized heart failure with preserved ejection fraction (HFpEF, EF≥50%) are analyzed retrospectively by reviewing the patient's demographic, clinical data, including patient medical history, initial clinical evaluations, and therapeutic interventions, as well as echocardiographic data in the hospital's electronic health records and relevant databases. The clinical outcome of enrolled patients are obtained through a team of three experienced cardiologists and twelve nursing professionals through outpatient consultations, telephone follow-ups, and community visit. The primary endpoint events are all-cause mortality, the second endpoints are the composite cardiovascular death and heart failure readmission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFpEF Group | – | –HFpEF (Heart failure with preserved ejection fraction): LVEF≥50%. Non-endpoint events group versus Endpoint events (all-cause death,cardiovascular death or heart failure readmission) group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who hospitalized the Xiangtan Central Hospital between May 1, 2014, and January 31, 2023, with the diagnosis of heart failure and met HFpEF criteria at final analysis.
Key inclusion criteria (2 listed)
- Patients discharged with diagnosis of heart failure were screened and met definition of heart failure with preserved ejection fraction (HFpEF) according to the 2021 European Society of Cardiology (ESC) guidelines at final analysis.
- 1）Heart failure signs and symptoms; 2）LVEF>50%;
Key exclusion criteria (1 listed)
- 1) age under 18 years; 2) life expectancy of less than one year due to non-cardiac conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause death（people）
Time frame: The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.
Risk factors of all-cause death are analyzed（Increase the factors that contribute to the occurrence of endpoint events）
1 secondary outcome
Cardiovascular death and Heart failure readmission（people）
Time frame: The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 40935414Zhu Y, Zhao W, Liu Z, Tan D, Tao L, He W, Jiang K, Huang H, Wu M, Tang L, Zeng J, Zhou S. Development and validation of a prediction model for all-cause death in heart failure patients with preserved ejection fraction: a single-centre cohort study in China. BMJ Open. 2025 Sep 10;15(9):e094909. doi: 10.1136/bmjopen-2024-094909.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Xiangtan Central Hospital.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause death（people） (time frame: The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487468, which also lists 1 linked publication.
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 Jul 2024.