Heart FailureREM-HFNCT02998788
Risk Evaluation and Management in Heart Failure
An observational study of Heart Failure and Risk Factor, Cardiovascular, run by Ruijin Hospital at 1 site in China.
Trial summary
This is an prospective study conducted in a Chinese heart failure population. The study investigates the effects of cardiovascular disease risk factors such as lifestyle behaviors,biomarkers and intermediate diseases on heart failure prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Risk Factor, Cardiovascular
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Hospitalized patients with primary discharge diagnosis of heart failure
Who may be able to join
- aged 18 and above
- inpatient with one of the following clinical situations:
- congestive heart failure (pulmonary edema,pulmonary congestion or peripheral edema)
- cardiogenic shock
- Insufficient high output cardiac
- with impaired cardiac function diagnosed by echocardiography
- able to provide informed consent
Who cannot join
- expressed refusal to participate in the baseline investigation or follow-up visits Severe co-morbidity associated with a reduction in life expectancy of less than 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Zhijun Wu, MD, 008613818908053, totito19822005@126.com
About this study
This is an prospective study conducted in a Chinese heart failure population. The study investigates the effects of cardiovascular disease risk factors such as lifestyle behaviors,biomarkers and intermediate diseases on heart failure prognosis.
Read the detailed description
Heart failure is the main cause of cardiovascular death. The primary goal of this study is to estimate the association of lifestyle behavior (e.g., alcohol, tea and coffee consumption, sedentary behavior, smoking habit, sleep disorder and physical activity), intermediate conditions (e.g., hypertension, diabetes and dyslipidemia), genetic risk factors and circulating biomarkers with heart failure prognosis. Another goal is to improve the health status and reduce cardiovascular events and death for heart failure patients via patient education, disease monitoring and medication titration. This study planned to consecutively enroll 1,000 heart failure patients fulfilling the inclusion criteria. Each participants will be followed up for at least 5 years. The study endpoints, all-cause mortality and cardiovascular events, will be identified by directly contacting participants during the follow-up surveys, checking pertinent medical records and discharge lists from the hospitals, or checking death certificates from local vital statistics offices. The Cox proportional hazard model will be used to estimate the risk factors for health outcomes in heart failure patients.
- Conditions
- Heart Failure, Risk Factor, Cardiovascular
- Keywords
- heart failure, risk factor, cardiovascular disease, lifestyle behavior
- Medical subject headings
- Heart Failure, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 10 years
A composite of cardiovascular events
A composite of myocardial infarction, revascularization, stroke, rehospitalization due to heart failure and cardiovascular death
Measured: 10 years
Secondary outcomes (5)
myocardial infarction
Measured: 10 years
revascularization
Measured: 10 years
stroke
Measured: 10 years
rehospitalization due to heart failure
Measured: 10 years
cardiovascular death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 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 Ruijin HospitalThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Jin, Ruijin Hospital
- Investigators
- Wei Jin, Professor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998788
- Sponsor's protocol ID
- RJ-81600198
- Acronym
- REM-HF
- Status last verified
- Dec 2016
- First submitted
- 10 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Evaluation and Management in Heart Failure
- ClinicalTrials.gov ID
- NCT02998788
- Acronym / sponsor ID
- REM-HF / RJ-81600198
- Conditions
- Heart Failure, Risk Factor, Cardiovascular
- Keywords
- heart failure, risk factor, cardiovascular disease, lifestyle behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- 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 is an prospective study conducted in a Chinese heart failure population. The study investigates the effects of cardiovascular disease risk factors such as lifestyle behaviors,biomarkers and intermediate diseases on heart failure prognosis.
Detailed description
Heart failure is the main cause of cardiovascular death. The primary goal of this study is to estimate the association of lifestyle behavior (e.g., alcohol, tea and coffee consumption, sedentary behavior, smoking habit, sleep disorder and physical activity), intermediate conditions (e.g., hypertension, diabetes and dyslipidemia), genetic risk factors and circulating biomarkers with heart failure prognosis. Another goal is to improve the health status and reduce cardiovascular events and death for heart failure patients via patient education, disease monitoring and medication titration. This study planned to consecutively enroll 1,000 heart failure patients fulfilling the inclusion criteria. Each participants will be followed up for at least 5 years. The study endpoints, all-cause mortality and cardiovascular events, will be identified by directly contacting participants during the follow-up surveys, checking pertinent medical records and discharge lists from the hospitals, or checking death certificates from local vital statistics offices. The Cox proportional hazard model will be used to estimate the risk factors for health outcomes in heart failure patients.
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
- Hospitalized patients with primary discharge diagnosis of heart failure
Key inclusion criteria (7 listed)
- aged 18 and above
- inpatient with one of the following clinical situations:
- with impaired cardiac function diagnosed by echocardiography
- able to provide informed consent
Key exclusion criteria (1 listed)
- expressed refusal to participate in the baseline investigation or follow-up visits Severe co-morbidity associated with a reduction in life expectancy of less than 12 months
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
All-cause mortality
Time frame: 10 years
A composite of cardiovascular events
Time frame: 10 years
A composite of myocardial infarction, revascularization, stroke, rehospitalization due to heart failure and cardiovascular death
5 secondary outcomes
myocardial infarction
Time frame: 10 years
revascularization
Time frame: 10 years
stroke
Time frame: 10 years
rehospitalization due to heart failure
Time frame: 10 years
cardiovascular death
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Wei Jin, Professor principal investigator
Ruijin Hospital
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 and Risk Factor, Cardiovascular, run by Ruijin Hospital 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 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: looking for participants now, as of the sponsor's last update on 20 Dec 2016. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhijun Wu, MD (008613818908053, totito19822005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 10 years). 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 20 Dec 2016.