NCT03951311Recruiting
Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure
Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
Source: ClinicalTrials.gov · Last updated 8 Oct 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Metabolic abnormalities (e.g., hypertension, diabetes mellitus, dyslipidemia, and obesity) and unhealthy lifestyle behaviors (e.g., smoking and drinking habits, sedentary behavior, sleep disorder and physical inactivity) and unhealthy diet (e.g., high sugar and high fat) are major risk factors for cardiovascular diseases mobility and mortality. The investigators sought to estimate the impact of metabolic abnormalities, lifestyle behavior and diet pattern on prognosis of heart failure. This study planned to consecutively enroll 1,500 participants with heart failure with reduced ejection fraction and heart failure with mid-range ejection fraction fulfilling the inclusion criteria. Each heart failure survivors will be followed up for 5 years. Information on metabolic diseases, lifestyle and diet pattern were obtained through standardized questionnaire. The major adverse cardiac events will be identified by reviewing pertinent medical records and discharge lists from the hospitals, or official death certificates collected at local death registration centers, or directly contacting participants' family. The Cox proportional hazard model will be used to assess the association between metabolic risk factors and lifestyle and diet habits and health outcomes in heart failure patients.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 14 May 2019
- Start date
- 1 Jun 2016
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Heart failure
- NCT number
- NCT03951311
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 1 Jun 2016 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- refusal of the drug treatment or intervention recommended by the guidelines.
Other illness
- cancer with a life expectancy of less than one year;
- endocarditis, pericardial diseases, or congenital heart diseases;
- heart failure secondary to non-cardiac diseases (e.g., pulmonary heart disease, infection, infiltration, metabolic derangements, severe anemia, sepsis, and arteriovenous fistula);
Age
- age \<14 years or ≥90 years;
Other
- pregnancy;
- participation in other trials;
- lack of informed consent;
Who the study is looking for
- aged 14 years or older;
- typical symptoms of heart failure according to the Framingham criteria;
- left ventricular ejection fraction (LVEF) \<50%, demonstrated by echocardiography or cardiac magnetic resonance, which include either patients with mid-range EF (HFmEF) or with reduced EF (HFrEF) with relevant structural and functional cardiac changes and/or elevated N-terminal pro-brain B-type natriuretic peptide (pro-BNP) (e.g., ≥400 pg/mL).
Age in the registry: 14 years to 90 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.