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出境医 / 临床实验 / Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure (MALD-HF)

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

Study Description
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

Study Design
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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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 10 years ]
    The mortality information was obtained from the local Vital Statistics Offices or directly contacting participants' family members.

  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 ]
    Myocardial infarction was diagnosed based on cardiac symptoms, positive cardiac biomarkers or electrocardiography

  2. non-fatal stroke [ Time Frame: 10 years ]
    Ischemic stroke and hemorrhagic stroke were defined as neurological deficit of cerebrovascular cause that lasted more than 24 hours or a significant lesion detected by computed tomography or magnetic resonance imaging

  3. revascularization [ Time Frame: 10 years ]
    revascularization due to recurrent ischemic CVD events

  4. rehospitalization due to heart failure [ Time Frame: 10 years ]
    Heart failure was diagnosed based on clinical symptoms such as dyspnea and edema, abnormal ventricular structure and ejection fraction, or an elevated B-type natriuretic peptide


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.

Eligibility Criteria
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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:

  1. Inability to complete the baseline questionnaires
  2. Inability to complete the follow-up investigations
  3. refusal to provide informed consent
Contacts and Locations

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
Tracking Information
First Submitted Date May 14, 2019
First Posted Date May 15, 2019
Last Update Posted Date March 12, 2020
Actual Study Start Date June 1, 2016
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2020)
  • All-cause mortality [ Time Frame: 10 years ]
    The mortality information was obtained from the local Vital Statistics Offices or directly contacting participants' family members.
  • cardiovascular mortality [ Time Frame: 10 years ]
    Death due to cardiovascular diseases
  • non-fatal cardiovascular events [ Time Frame: 10 years ]
    A composite of myocardial infarction, stroke, rehospitalization due to heart failure
Original Primary Outcome Measures
 (submitted: May 14, 2019)
  • All-cause mortality [ Time Frame: 10 years ]
  • cardiovascular mortality [ Time Frame: 10 years ]
    Death due to cardiovascular diseases
  • non-fatal cardiovascular events [ Time Frame: 10 years ]
    A composite of myocardial infarction, stroke, rehospitalization due to heart failure
Change History
Current Secondary Outcome Measures
 (submitted: March 10, 2020)
  • non-fatal myocardial infarction [ Time Frame: 10 years ]
    Myocardial infarction was diagnosed based on cardiac symptoms, positive cardiac biomarkers or electrocardiography
  • non-fatal stroke [ Time Frame: 10 years ]
    Ischemic stroke and hemorrhagic stroke were defined as neurological deficit of cerebrovascular cause that lasted more than 24 hours or a significant lesion detected by computed tomography or magnetic resonance imaging
  • revascularization [ Time Frame: 10 years ]
    revascularization due to recurrent ischemic CVD events
  • rehospitalization due to heart failure [ Time Frame: 10 years ]
    Heart failure was diagnosed based on clinical symptoms such as dyspnea and edema, abnormal ventricular structure and ejection fraction, or an elevated B-type natriuretic peptide
Original Secondary Outcome Measures
 (submitted: May 14, 2019)
  • non-fatal myocardial infarction [ Time Frame: 10 years ]
  • non-fatal stroke [ Time Frame: 10 years ]
  • revascularization [ Time Frame: 10 years ]
  • rehospitalization due to heart failure [ Time Frame: 10 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure
Official Title Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
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
Condition
  • Heart Failure
  • Metabolic Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 14, 2019) 		1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2026
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility 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:

  1. Inability to complete the baseline questionnaires
  2. Inability to complete the follow-up investigations
  3. refusal to provide informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Zhijun Wu, MD 008613818908053 totito19822005@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03951311
Other Study ID Numbers RJ-20172004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Zhijun Wu, Ruijin Hospital
Study Sponsor Ruijin Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Zhijun Wu, MD Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date March 2020

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