Heart Failure With Preserved Ejection FractionNCT05053256
The Relationship Between Heart Function and Metabolism in HFpEF Patients
An observational study of Heart Failure With Preserved Ejection Fraction, run by Chongqing Medical University at 1 site in China.
Trial summary
HFpEF has gradually become the most common form of heart failure. Studies have found that metabolic abnormalities and chronic inflammation ultimately lead to HFpEF by promoting heart remodeling. However, there are few relevant studies and the mechanism is still unclear. 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
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Sep 2023
- 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 patients with preserved ejection fraction (HFpEF)
Who may be able to join
- Adult aged ≥ 18 years old
- Patients diagnosed with HFpEF;
- Diagnostic criteria including:
- LVEF 50% or higher;
- BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
- Presence of symptoms and/or signs of heart failure;
- At least one additional criteria: relevant structure heart disease or diastolic dysfunction
Who cannot join
- Severe liver failure;
- Other causes of shortness of breath, such as severe pulmonary disease or severe ● chronic obstructive pulmonary disease;
- Primary pulmonary hypertension.
- Severe left valvular heart disease.
- Long-term bedridden or unable to move autonomously
- Age < 18
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
Official title: The Relationship Between Heart Function and Metabolism in Heart Failure With Preserved Ejection Fraction Patients
HFpEF has gradually become the most common form of heart failure. Studies have found that metabolic abnormalities and chronic inflammation ultimately lead to HFpEF by promoting heart remodeling. However, there are few relevant studies and the mechanism is still unclear.
Read the detailed description
However, heart failure with preserved ejection fraction is difficult to diagnose and treat due to its unknown pathogenesis and poor prognosis. Ventricular diastolic dysfunction and retention of left ventricular ejection fraction are important pathological features of Heart failure with preserved ejection fraction. Currently, it is widely believed to be a clinical syndrome associated with old age, women, obesity, diabetes, hypertension, atrial fibrillation, coronary heart disease, atherosclerosis, etc. However, the specific mechanism of heart failure with preserved ejection fraction caused by the above-mentioned complications is unknown. In conclusion, the investigators intend to explore the pathogenesis of heart failure with preserved ejection fraction by observing the changes of heart and body metabolism in patients with heart failure with preserved ejection fraction, and provide a basis for the diagnosis and treatment.
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 | Heart failure with preserved ejection fraction | |
| HFrEF | Heart failure with reduced ejection fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
The muscle mass of HFpEF patients, such as thigh muscle mass
Measured: On admission
Blood uric acid
The blood uric acid of HFpEF patients
Measured: On admission
Body fat content
The body fat content of HFpEF patients, such as fat percentage and visceral fat area.
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Oct 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (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
- NCT05053256
- Sponsor's protocol ID
- 2021-08-29
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2021
- Last updated
- 24 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 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Heart Function and Metabolism in Heart Failure With Preserved Ejection Fraction Patients
- ClinicalTrials.gov ID
- NCT05053256
- Acronym / sponsor ID
- 2021-08-29
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 22 Sep 2021 (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.
HFpEF has gradually become the most common form of heart failure. Studies have found that metabolic abnormalities and chronic inflammation ultimately lead to HFpEF by promoting heart remodeling. However, there are few relevant studies and the mechanism is still unclear.
Detailed description
However, heart failure with preserved ejection fraction is difficult to diagnose and treat due to its unknown pathogenesis and poor prognosis. Ventricular diastolic dysfunction and retention of left ventricular ejection fraction are important pathological features of Heart failure with preserved ejection fraction. Currently, it is widely believed to be a clinical syndrome associated with old age, women, obesity, diabetes, hypertension, atrial fibrillation, coronary heart disease, atherosclerosis, etc. However, the specific mechanism of heart failure with preserved ejection fraction caused by the above-mentioned complications is unknown. In conclusion, the investigators intend to explore the pathogenesis of heart failure with preserved ejection fraction by observing the changes of heart and body metabolism in patients with heart failure with preserved ejection fraction, and provide a basis for the diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | –Heart failure with preserved ejection fraction |
| HFrEF | – | –Heart failure with reduced ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with preserved ejection fraction (HFpEF)
Key inclusion criteria (7 listed)
- Adult aged ≥ 18 years old
- Patients diagnosed with HFpEF;
- LVEF 50% or higher;
- BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
- Presence of symptoms and/or signs of heart failure;
Key exclusion criteria (6 listed)
- Severe liver failure;
- Other causes of shortness of breath, such as severe pulmonary disease or severe ● chronic obstructive pulmonary disease;
- Primary pulmonary hypertension.
- Severe left valvular heart disease.
- Long-term bedridden or unable to move autonomously
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
Muscle mass
Time frame: On admission
The muscle mass of HFpEF patients, such as thigh muscle mass
Blood uric acid
Time frame: On admission
The blood uric acid of HFpEF patients
Body fat content
Time frame: On admission
The body fat content of HFpEF patients, such as fat percentage and visceral fat area.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
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RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
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Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
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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.
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, 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 7 inclusion and 6 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 24 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?
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?
Muscle mass (time frame: On admission). The study lists 3 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 24 Aug 2022.