Heart Failure With Preserved Ejection FractionNCT05496439
Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction, run by Chongqing Medical University at 1 site in China.
Trial summary
Study of the prognosis of patients with heart failure with preserved ejection fraction 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
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 6 Jul 2022
- 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 with heart failure with preserved ejection fraction
Who may be able to join
- Adult aged >=18years old;
- Diagnosed with HFpEF.Diagnostic criteria including:
- 1）left ventricular ejection fraction ≥50%； 2）with the symptoms and/or signs of heart failure； 3）BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL； 4）at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction
Who cannot join
- Age <18 years old；
- LVEF less than 45% at any time;
- cancer diagnosis.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing
About this study
Study of the prognosis of patients with heart failure with preserved ejection fraction
Read the detailed description
Obesity is an independent risk factor for heart failure with preserved ejection fraction (HFpEF), however, the impact of visceral fat area (VFA) in patients with HFpEF is unclear. According to established process of patients' selection, a total of 172 patients whose mean age was 72 years were included in this study, and the median follow-up duration was 395.5 days(interquartile range: 207.5 to 535.5 days). All patients were divided into two groups based on the best cut-off value of VFA, and the primary outcome of this study was all-cause death in patients with HFpEF. The aim of this study was to clarify whether VFA has prognostic value in patients with HFpEF by Kaplan-Meier analysis and cox analysis.
- Keywords
- visceral fat area
What is being measured
The primary outcome is the main question the study is designed to answer.
death
all-cause death
Measured: The median follow-up time of 395.5 days(interquartile range: 207.5 to 535.5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Mar 2020
- Primary completion22 May 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496439
- Sponsor's protocol ID
- 2022-08
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05496439
- Acronym / sponsor ID
- 2022-08
- Keywords
- visceral fat area
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 11 Aug 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.
Study of the prognosis of patients with heart failure with preserved ejection fraction
Detailed description
Obesity is an independent risk factor for heart failure with preserved ejection fraction (HFpEF), however, the impact of visceral fat area (VFA) in patients with HFpEF is unclear. According to established process of patients' selection, a total of 172 patients whose mean age was 72 years were included in this study, and the median follow-up duration was 395.5 days(interquartile range: 207.5 to 535.5 days). All patients were divided into two groups based on the best cut-off value of VFA, and the primary outcome of this study was all-cause death in patients with HFpEF. The aim of this study was to clarify whether VFA has prognostic value in patients with HFpEF by Kaplan-Meier analysis and cox analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with heart failure with preserved ejection fraction
Key inclusion criteria (3 listed)
- Adult aged >=18years old;
- Diagnosed with HFpEF.Diagnostic criteria including:
- 1）left ventricular ejection fraction ≥50%； 2）with the symptoms and/or signs of heart failure； 3）BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL； 4）at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction
Key exclusion criteria (3 listed)
- Age <18 years old；
- LVEF less than 45% at any time;
- cancer diagnosis.
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
death
Time frame: The median follow-up time of 395.5 days(interquartile range: 207.5 to 535.5 days)
all-cause death
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 11 Aug 2022.
- 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.
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 Heart Failure With Preserved Ejection Fraction, run by Chongqing 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 3 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 11 Aug 2022. 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?
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?
death (time frame: The median follow-up time of 395.5 days(interquartile range: 207.5 to 535.5 days)). 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 11 Aug 2022.