Heart FailureNCT05278026
Cohort Study of Heart Failure With Preserved Ejection Fraction in Chinese Han
An observational study of Heart Failure, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To analyze factors contributing to the development and prognosis of 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
- What is being tested?
- guideline recommended routine treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 1 Jan 2026
- 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
- Adult, Older adult
Study population: Subjects were enrolled from Nanjing First Hospital, a public tertiary care university hospital in Nanjing, China.
Who may be able to join
- Patients with CVD, defined as at least one diagnosis of coronary heart disease, hypertension, type 2 diabetes or cardiomyopathy. The definition of coronary heart disease was stenosis of the main coronary arteries ≥ 50% using percutaneous coronary angiography or coronary computed tomography angiography findings. The definition of hypertension was systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg or pharmacological treatment. The definition of type 2 diabetes was fasting blood glucose ≥ 7.0 mmol/L, random blood glucose ≥ 11.1 mmol/L and HbA1c > 6.5% or the or the use of hypoglycaemic medications. Cardiomyopathy was defined as the presence of cardiac insufficiency in patients with dilated cardiomyopathy suggested by percutaneous coronary angiography or coronary CT angiography use of hypoglycaemic medications.
Who cannot join
- primary diagnoses of atherosclerosis (stenosis of the main coronary arteries < 50%), congenital heart diseases, arrhythmia, lung diseases, aortic dissection, peripheral vascular diseases, pericardial diseases, myocarditis, hypertrophic cardiomyopathy, heart valvular diseases, cardiophobia, costal chondritis, shock, thyroid diseases, infection or concomitant liver or renal dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
俊霞 张, MD, 15366155682, zhangjunshia@njmu.edu.cn
About this study
To analyze factors contributing to the development and prognosis of heart failure with preserved ejection fraction.
Read the detailed description
Based on previous studies on development of heart failure with preserved ejection fraction (HFpEF), racial/ethnical background should be underscored when evaluating risk f actors for HFpEF incidence. As the ageing population increases sharply in China, HFpEF represents the dominant phenotype of all patients diagnosed with heart failure. In this cohort study, the investigators evaluated exposures or risk factors for HFpEF in Chinese Han patients with cardiovascular diseases (CVD). Our study may provide preventive and therapeutic targets for HFpEF in Chinese CVD patients.
- Conditions
- Heart Failure
- Being tested
- guideline recommended routine treatment
- Keywords
- Cardiovascular diseases; Diastolic dysfunction;Systolic dysfunction; Heart failure; Risk factor
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guideline recommended routine treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| HFrEF | heart failure with reduced ejection fraction Receives: Other: guideline recommended routine treatment | |
| HFpEF | heart failure with preserved ejection fraction Receives: Other: guideline recommended routine treatment | |
| nonfailing control | patients without heart failure Receives: Other: guideline recommended routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
One minute sit-to-stand test (1-min STST)
Briefly, each subject was instructed in sitting position to extend both knees at the same time, starting from a 90° knee flexion position to a 180° extension, which works the thigh muscles, and especially the quadriceps.
Measured: up to 4 weeks
Worsening of heart failure (HF)
worsening of symptoms defined as either failure to improve (persistent symptoms and signs of acute HF during treatment) or recurrent symptoms and signs of acute HF, pulmonary edema, or cardiogenic shock after initial stabilization , either of which requiring increased use of diuretics (as outpatient or inpatient), addition of a new intravenous therapy (diuretics, inotrope, or vasodilator) or mechanical support
Measured: an average of 1 year
Hospitalization due to worsening of heart failure (HF)
hospitalization due to worsening HF requiring intravenous pharmacological agents (inotrope or vasodilator), mechanical ventilation, mechanical support or ultra- filtration, hemofiltration, or dialysis
Measured: an average of 1 year
Secondary outcomes (1)
all-cause and cardiogenic deaths
all-cause and cardiogenic deaths
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Jan 2014
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278026
- Sponsor's protocol ID
- ChiHFpEF-Cohort
- Status last verified
- Mar 2022
- First submitted
- 17 Nov 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Heart Failure With Preserved Ejection Fraction in Chinese Han
- ClinicalTrials.gov ID
- NCT05278026
- Acronym / sponsor ID
- ChiHFpEF-Cohort
- Conditions
- Heart Failure
- Keywords
- Cardiovascular diseases; Diastolic dysfunction;Systolic dysfunction; Heart failure; Risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 14 Mar 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.
To analyze factors contributing to the development and prognosis of heart failure with preserved ejection fraction.
Detailed description
Based on previous studies on development of heart failure with preserved ejection fraction (HFpEF), racial/ethnical background should be underscored when evaluating risk f actors for HFpEF incidence. As the ageing population increases sharply in China, HFpEF represents the dominant phenotype of all patients diagnosed with heart failure. In this cohort study, the investigators evaluated exposures or risk factors for HFpEF in Chinese Han patients with cardiovascular diseases (CVD). Our study may provide preventive and therapeutic targets for HFpEF in Chinese CVD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFrEF | – | Other: guideline recommended routine treatmentheart failure with reduced ejection fraction |
| HFpEF | – | Other: guideline recommended routine treatmentheart failure with preserved ejection fraction |
| nonfailing control | – | Other: guideline recommended routine treatmentpatients without heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects were enrolled from Nanjing First Hospital, a public tertiary care university hospital in Nanjing, China.
Key inclusion criteria (1 listed)
- Patients with CVD, defined as at least one diagnosis of coronary heart disease, hypertension, type 2 diabetes or cardiomyopathy. The definition of coronary heart disease was stenosis of the main coronary arteries ≥ 50% using percutaneous coronary angiography or coronary computed tomography angiography findings. The definition of hypertension was systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg or pharmacological treatment. The definition of type 2 diabetes was fasting blood glucose ≥ 7.0 mmol/L, random blood glucose ≥ 11.1 mmol/L and HbA1c > 6.5% or the or the use of hypoglycaemic medications. Cardiomyopathy was defined as the presence of cardiac insufficiency in patients with dilated cardiomyopathy suggested by percutaneous coronary angiography or coronary CT angiography use of hypoglycaemic medications.
Key exclusion criteria (1 listed)
- primary diagnoses of atherosclerosis (stenosis of the main coronary arteries < 50%), congenital heart diseases, arrhythmia, lung diseases, aortic dissection, peripheral vascular diseases, pericardial diseases, myocarditis, hypertrophic cardiomyopathy, heart valvular diseases, cardiophobia, costal chondritis, shock, thyroid diseases, infection or concomitant liver or renal dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guideline recommended routine treatment | Other | HFpEF, HFrEF, nonfailing control |
Primary outcome
One minute sit-to-stand test (1-min STST)
Time frame: up to 4 weeks
Briefly, each subject was instructed in sitting position to extend both knees at the same time, starting from a 90° knee flexion position to a 180° extension, which works the thigh muscles, and especially the quadriceps.
Worsening of heart failure (HF)
Time frame: an average of 1 year
worsening of symptoms defined as either failure to improve (persistent symptoms and signs of acute HF during treatment) or recurrent symptoms and signs of acute HF, pulmonary edema, or cardiogenic shock after initial stabilization , either of which requiring increased use of diuretics (as outpatient or inpatient), addition of a new intravenous therapy (diuretics, inotrope, or vasodilator) or mechanical support
Hospitalization due to worsening of heart failure (HF)
Time frame: an average of 1 year
hospitalization due to worsening HF requiring intravenous pharmacological agents (inotrope or vasodilator), mechanical ventilation, mechanical support or ultra- filtration, hemofiltration, or dialysis
1 secondary outcome
all-cause and cardiogenic deaths
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Lp(a) \[Lipoprotein(a)\]-Related Risk of Heart Failure Is Evident in Whites but Not in Other Racial/Ethnic GroupsLink provided by the sponsor.
- Race/Ethnic Differences in Outcomes Among Hospitalized Medicare Patients With Heart Failure and Preserved Ejection FractionLink provided by the sponsor.
- Racial Differences in Characteristics and Outcomes of Patients With Heart Failure and Preserved Ejection Fraction in the Treatment of Preserved Cardiac Function Heart Failure TrialLink provided by the sponsor.
- 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.
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, run by Nanjing First Hospital, Nanjing 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 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: status not confirmed, as of the sponsor's last update on 14 Mar 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 Junxia Zhang, MD (15366155682, zhangjunshia@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One minute sit-to-stand test (1-min STST) (time frame: up to 4 weeks). 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 14 Mar 2022.