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NCT Number: NCT02998788

Risk Evaluation and Management in Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Zhijun Wu, MD

CONTACT

[email protected]

008613818908053

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 10 years

  2. A composite of cardiovascular events

    Time frame: 10 years

    A composite of myocardial infarction, revascularization, stroke, rehospitalization due to heart failure and cardiovascular death

Secondary outcomes

  1. myocardial infarction

    Time frame: 10 years

  2. revascularization

    Time frame: 10 years

  3. stroke

    Time frame: 10 years

  4. rehospitalization due to heart failure

    Time frame: 10 years

  5. cardiovascular death

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Zhijun Wu, MD

CONTACT

[email protected]

008613818908053

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Acronym: REM-HF

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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