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Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure (MALD-HF)

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ClinicalTrials.gov Identifier: NCT03951311
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Zhijun Wu, Ruijin Hospital

Brief Summary:
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 fulfilling the inclusion criteria. Each heart failure survivors will be followed up for 5-10 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.

Condition or disease
Heart Failure Metabolic Disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 10 years ]
  2. cardiovascular mortality [ Time Frame: 10 years ]
    Death due to cardiovascular diseases

  3. non-fatal cardiovascular events [ Time Frame: 10 years ]
    A composite of myocardial infarction, stroke, rehospitalization due to heart failure


Secondary Outcome Measures :
  1. non-fatal myocardial infarction [ Time Frame: 10 years ]
  2. non-fatal stroke [ Time Frame: 10 years ]
  3. revascularization [ Time Frame: 10 years ]
  4. rehospitalization due to heart failure [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Fasting venous blood samples were drawn and transfused into vacuum tubes containing EDTA after admission. These samples were stored and further analyzed in the Central Laboratory of Ruijin Hospital.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients diagnosed with heart failure who had impaired cardiac function or abnormal cardiac structure with elevated blood BNP concentrations
Criteria

Inclusion Criteria:

(1) aged 18 and above; (2) symptoms with or without signs of congestive heart failure (pulmonary edema, pulmonary congestion or peripheral edema); (3) elevated blood natriuretic peptide levels (BNP ≥35pg/mL or NT-proBNP≥125pg/mL); (4) Impaired cardiac function diagnosed by cardiac imaging tests (e.g., echocardiography or cardiac magnetic resonance); (5) a: left ventricular ejection fraction (LVEF) <40%; or LVEF>40% with structural change (e.g., left ventricle hypertrophy, left atrial enlargement or diastolic dysfunction).

Exclusion Criteria:

Inability to complete the baseline questionnaires or follow-up investigations or refusal to provide informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951311


Contacts
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Contact: Zhijun Wu, MD 008613818908053 totito19822005@126.com

Locations
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China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Zhijun Wu, MD    008613818908053    totito19822005@126.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Zhijun Wu, MD Ruijin Hospital

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Responsible Party: Zhijun Wu, MD,Ruijin Hospital, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03951311     History of Changes
Other Study ID Numbers: RJ-20172004
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases