Clinical trial NCT02998788: Risk Evaluation and Management in Heart Failure
Official title: Risk Evaluation and Management in Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Risk Factor, Cardiovascular
Keywords: heart failure
risk factor
cardiovascular disease
lifestyle behavior
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with primary discharge diagnosis of heart failure

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: All-cause mortality
timeFrame: 10 years
measure: A composite of cardiovascular events
timeFrame: 10 years
Secondary outcomes:
measure: myocardial infarction
timeFrame: 10 years
measure: revascularization
timeFrame: 10 years
measure: stroke
timeFrame: 10 years
measure: rehospitalization due to heart failure
timeFrame: 10 years
measure: cardiovascular death
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Wei Jin, Professor
role: PRINCIPAL_INVESTIGATOR
References: