Heart Failure With Mid Range Ejection FractionOUDI-HFNCT05240118
Outcome of Discharged HFmrEF Patients
An observational study of Heart Failure With Mid Range Ejection Fraction, run by Xiangtan Central Hospital.
Trial summary
This study aimed to define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who discharged from the Xiangtan Central Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure With Mid Range Ejection Fraction
- How many people
- 1,693 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who attended the Xiangtan Cengtral Hospital in the time period between January 1, 2015 and August 31, 2020 with the diagnosis of HFmrEF.
Who may be able to join
- Diagnosis: Heart failure with mildly reduced ejection fraction (HFmrEF) Presence of symptoms and/or signs of HF, and a mildly reduced LVEF (41- 49%); Elevated natriuretic peptides (BNP >35 pg/mL or NT-proBNP >125 pg/mL); Other evidence of structural heart disease.
Who cannot join
- none
About this study
Official title: Risk Factors of Short-term and Long-term OUtcome in DIscharged Patients With Heart Failure With Mildly Reduced Ejection Fraction
This study aimed to define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who discharged from the Xiangtan Central Hospital. Through the long-term follow-up the cardiovascular outcome of patients being discharged from the hospital, the risk factors related to cardiovascular outcome (cardiac death or heart failure-related hospitalization) will be explored to provide clinical evidence to intervene the discharged HFmrEF patients aiming to improve patients outcome in the future clinical practice.
Read the detailed description
This study aimed to define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who hospitalized in Xiangtan Central Hospital from January 1, 2015 to August 31, 2020. The patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call, the risk factors related to cardiovascular outcome (cardiac death or heart failure-related hospitalization) will be explored to provide clinical evidence to intervene the discharged HFmrEF patients aiming to improve patients outcome in the future clinical practice.
The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed by retrospectively by reviewing patients medical records, laboratory and clinical imaging examination results during initial hospitalization, clinical outcome of enrolled patients will be obtained through clinical visit and telephone call. The primary endpoint is the composite cardiac events (cardiac death or heart failure related rehospitalization). The secondary endpoint is the all-cause death.
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 |
|---|---|---|
| HFmrEF Group | HFmrEF (Heart failure with mildly reduced ejection fraction): ESC Guideline heart failure 2021: patients with LVEF 41-49%. non-cardiac events group versus cardiac events (cardiac death or heart failure-related rehospitalization) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term risk factors related to cardiac events (cardiac death or heart failure-related rehospitalization) in discharged patients with heart failure with mildly reduced ejection fraction
Primary Outcome Measure:
1.Long-term risk factors related to cardiac events (cardiac death or heart failure-related rehospitalization) in discharged patients with heart failure with mildly reduced ejection fraction The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed retrospectively by reviewing their medical records, laboratory and clinical imaging examination results during initial hospitalization, clinical outcome up to the study end will be obtained through clinical visit and telephone call.
Measured: The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call.
Secondary outcomes (1)
Long-term risk factors related to all-cause death in discharged patients with heart failure with mildly reduced ejection fraction
- Long-term risk factors related to all-cause death in discharged patients with heart failure with mildly reduced ejection fraction The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed retrospectively by reviewing their medical records, laboratory and clinical imaging examination results during initial hospitalization, all-cause death up to the study end will be obtained through clinical visit and telephone call.
Measured: The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jan 2015
- Primary completion31 Aug 2020
- Study completion31 Aug 2021
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 Mid Range 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
- 1,693 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
- Investigators
- Jianping Zeng, M.D., Principal investigator, Xiangtan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240118
- Sponsor's protocol ID
- 2021/12
- Acronym
- OUDI-HF
- Status last verified
- Feb 2022
- First submitted
- 3 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Z, Zhu Y, Chen S, Wu M, Huang H, Peng K, Zhang L, Zhao W, Peng X, Li N, Zhang H, Zhou Y, Peng Y, Fan J, Zeng J. Sex differences in patients with heart failure and mildly reduced left ventricular ejection fraction. Sci Rep. 2023 Apr 26;13(1):6832. doi: 10.1038/s41598-023-33733-8.
PubMed 37100821
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Short-term and Long-term OUtcome in DIscharged Patients With Heart Failure With Mildly Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT05240118
- Acronym / sponsor ID
- OUDI-HF / 2021/12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,693 participants (actual)
- Lead sponsor
- Xiangtan Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 Feb 2022 (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 define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who discharged from the Xiangtan Central Hospital. Through the long-term follow-up the cardiovascular outcome of patients being discharged from the hospital, the risk factors related to cardiovascular outcome (cardiac death or heart failure-related hospitalization) will be explored to provide clinical evidence to intervene the discharged HFmrEF patients aiming to improve patients outcome in the future clinical practice.
Detailed description
This study aimed to define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who hospitalized in Xiangtan Central Hospital from January 1, 2015 to August 31, 2020. The patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call, the risk factors related to cardiovascular outcome (cardiac death or heart failure-related hospitalization) will be explored to provide clinical evidence to intervene the discharged HFmrEF patients aiming to improve patients outcome in the future clinical practice.
The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed by retrospectively by reviewing patients medical records, laboratory and clinical imaging examination results during initial hospitalization, clinical outcome of enrolled patients will be obtained through clinical visit and telephone call. The primary endpoint is the composite cardiac events (cardiac death or heart failure related rehospitalization). The secondary endpoint is the all-cause death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFmrEF Group | – | –HFmrEF (Heart failure with mildly reduced ejection fraction): ESC Guideline heart failure 2021: patients with LVEF 41-49%. non-cardiac events group versus cardiac events (cardiac death or heart failure-related rehospitalization) group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who attended the Xiangtan Cengtral Hospital in the time period between January 1, 2015 and August 31, 2020 with the diagnosis of HFmrEF.
Key inclusion criteria (1 listed)
- Diagnosis: Heart failure with mildly reduced ejection fraction (HFmrEF) Presence of symptoms and/or signs of HF, and a mildly reduced LVEF (41- 49%); Elevated natriuretic peptides (BNP >35 pg/mL or NT-proBNP >125 pg/mL); Other evidence of structural heart disease.
Key exclusion criteria (1 listed)
- none
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
Long-term risk factors related to cardiac events (cardiac death or heart failure-related rehospitalization) in discharged patients with heart failure with mildly reduced ejection fraction
Time frame: The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call.
Primary Outcome Measure: 1.Long-term risk factors related to cardiac events (cardiac death or heart failure-related rehospitalization) in discharged patients with heart failure with mildly reduced ejection fraction The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed retrospectively by reviewing their medical records, laboratory and clinical imaging examination results during initial hospitalization, clinical outcome up to the study end will be obtained through clinical visit and telephone call.
1 secondary outcome
Long-term risk factors related to all-cause death in discharged patients with heart failure with mildly reduced ejection fraction
Time frame: The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call
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 15 Feb 2022.
- Derived from this study: PubMed 37100821Liu Z, Zhu Y, Chen S, Wu M, Huang H, Peng K, Zhang L, Zhao W, Peng X, Li N, Zhang H, Zhou Y, Peng Y, Fan J, Zeng J. Sex differences in patients with heart failure and mildly reduced left ventricular ejection fraction. Sci Rep. 2023 Apr 26;13(1):6832. doi: 10.1038/s41598-023-33733-8.
- Individual participant dataSharing planned: No
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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.
Jianping Zeng, M.D. principal investigator
Xiangtan Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Mid Range 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 1 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 15 Feb 2022. 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?
Long-term risk factors related to cardiac events (cardiac death or heart failure-related rehospitalization) in discharged patients with heart failure with mildly reduced ejection fraction (time frame: The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call.). 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 NCT05240118, 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 15 Feb 2022.