Heart Failure With Preserved Ejection FractionNCT06379152
Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction and Prognathism, run by Chongqing Medical University at 1 site in China.
Trial summary
Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic… 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, Prognathism
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2020to 1 Jul 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: heart failure with preserved ejection fraction (HFpEF)
Who may be able to join
- Adult aged ≥18 years old；
- Diagnosed with HFpEF.
- Diagnostic criteria including:
- left ventricular ejection fraction ≥ 50%;
- with the symptoms and/or signs of heart failure;
- Patients in sinus rhythm：BNP≥35pg/ml and/or NT-proBNP≥125pg/ml；Patients with atrial fibrillation：BNP≥105pg/ml and/or NT-proBNP≥365pg/ml.
Who cannot join
- LVEF less than 49% at any time
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Dongying Zhang, doctor, +8613608398395, zdy.chris@qq.com
About this study
Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear.
Read the detailed description
Patients with heart failure with preserved ejection fraction account for approximately 50% of all heart failure patients, have approximately 1.4 hospitalisations per year and an annual mortality rate of approximately 15%. Till now, there have no definitively proven therapies that can reduce their morbidity and mortality, HFpEF Patients have a poor prognosis. The current study found that the prognosis of patients with HFpEF may be related to the heterogeneity of the disease, its various phenotypes and multifactorial pathophysiology, which has not been fully elucidated. The current study found that bilirubin is a risk factor for adverse outcomes of various HFpEF-related complications, but the relationship between direct bilirubin and prognosis of HFpEF has not been reported. Therefore the investigators speculate that direct bilirubin is a predictor of prognosis of HFpEF patients.
- Keywords
- Heart Failure with Preserved Ejection Fraction, Bilirubin, Prognosis
- Medical subject headings
- Prognathism
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 |
|---|---|---|
| DB≤6.8µmol/L | heart failure with preserved ejection fraction patients with direct bilirubn ≤6.8µmol/L | |
| DB>6.8µmol/L | heart failure with preserved ejection fraction patients with direct bilirubn >6.8µmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of direct bilirubin
The level of direct bilirubin
Measured: The day when patients on admission
a composite of heart failure rehospitalization or all-cause mortality
a composite of heart failure rehospitalization or all-cause mortality
Measured: In an average of 3 year after discharge
Secondary outcomes (2)
heart failure rehospitalization
heart failure rehospitalization
Measured: In an average of 3 year after discharge
all-cause mortality
all-cause mortality
Measured: In an average of 3 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start20 Sep 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- Dongying Zhang, doctor, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379152
- Sponsor's protocol ID
- 2024-04-16
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 23 Apr 2024
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06379152
- Acronym / sponsor ID
- 2024-04-16
- Keywords
- Heart Failure with Preserved Ejection Fraction, Bilirubin, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 23 Apr 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.
Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear.
Detailed description
Patients with heart failure with preserved ejection fraction account for approximately 50% of all heart failure patients, have approximately 1.4 hospitalisations per year and an annual mortality rate of approximately 15%. Till now, there have no definitively proven therapies that can reduce their morbidity and mortality, HFpEF Patients have a poor prognosis. The current study found that the prognosis of patients with HFpEF may be related to the heterogeneity of the disease, its various phenotypes and multifactorial pathophysiology, which has not been fully elucidated. The current study found that bilirubin is a risk factor for adverse outcomes of various HFpEF-related complications, but the relationship between direct bilirubin and prognosis of HFpEF has not been reported. Therefore the investigators speculate that direct bilirubin is a predictor of prognosis of HFpEF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DB≤6.8µmol/L | – | –heart failure with preserved ejection fraction patients with direct bilirubn ≤6.8µmol/L |
| DB>6.8µmol/L | – | –heart failure with preserved ejection fraction patients with direct bilirubn >6.8µmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- heart failure with preserved ejection fraction (HFpEF)
Key inclusion criteria (6 listed)
- Adult aged ≥18 years old；
- Diagnosed with HFpEF.
- left ventricular ejection fraction ≥ 50%;
- with the symptoms and/or signs of heart failure;
- Patients in sinus rhythm：BNP≥35pg/ml and/or NT-proBNP≥125pg/ml；Patients with atrial fibrillation：BNP≥105pg/ml and/or NT-proBNP≥365pg/ml.
Key exclusion criteria (1 listed)
- LVEF less than 49% at any time
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
The level of direct bilirubin
Time frame: The day when patients on admission
The level of direct bilirubin
a composite of heart failure rehospitalization or all-cause mortality
Time frame: In an average of 3 year after discharge
a composite of heart failure rehospitalization or all-cause mortality
2 secondary outcomes
heart failure rehospitalization
Time frame: In an average of 3 year after discharge
all-cause mortality
Time frame: In an average of 3 year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Preserved Ejection Fraction
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
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Dongying Zhang, doctor study director
First Affiliated Hospital of Chongqing Medical University
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 and Prognathism, 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 6 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongying Zhang, doctor (+8613608398395, zdy.chris@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of direct bilirubin (time frame: The day when patients on admission). 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 23 Apr 2024.