Heart FailureMALD-HFNCT03951311
Metabolic Abnormalities, Lifestyle and Diet Pattern in Heart Failure
An observational study of Heart Failure and Metabolic Disease, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Heart Failure, Metabolic Disease
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Hospitalized patients diagnosed with heart failure who had impaired cardiac function or abnormal cardiac structure with elevated blood BNP concentrations
Who may be able to join
- 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).
Who cannot join
- age <14 years or ≥90 years;
- pregnancy;
- cancer with a life expectancy of less than one year;
- participation in other trials;
- 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);
- lack of informed consent;
- refusal of the drug treatment or intervention recommended by the guidelines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Zhijun Wu, MD, 008613818908053, totito19822005@126.com
About this study
Official title: Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
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.
- Conditions
- Heart Failure, Metabolic Disease
- Medical subject headings
- Heart Failure, Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
a composite of cardiovascular mortality or hospitalization due to subjectively and objectively worsening HF
An independent committee of experts including three physicians reviews all the death certificates and medical records for adjudicating the death cases and all suspected CVD cases biennially from the index episode, via telephone contacting patients' family members or reviewing medical records and the Hospital Discharge Register data.
Measured: 5 years
Secondary outcomes (2)
cardiovascular mortality
sudden death or deaths due to CVD events
Measured: 5 years
hospitalization due to worsening HF
the adjudicated hospitalizations due to subjectively and objectively worsening HF
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jun 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Wu, Ruijin Hospital
- Investigators
- Zhijun Wu, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951311
- Sponsor's protocol ID
- RJ-20172004
- Acronym
- MALD-HF
- Status last verified
- Sep 2021
- First submitted
- 14 May 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jin Y, Huang H, Zhou Q, Dong F, Lu L, Gao X, Wu Z. Prospective assessing metabolic abnormalities, lifestyle and dietary pattern in a Chinese population with heart failure: the MALD-HF study protocol. BMJ Open. 2022 May 2;12(5):e049225. doi: 10.1136/bmjopen-2021-049225.
PubMed 35501092
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT03951311
- Acronym / sponsor ID
- MALD-HF / RJ-20172004
- Conditions
- Heart Failure, Metabolic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients diagnosed with heart failure who had impaired cardiac function or abnormal cardiac structure with elevated blood BNP concentrations
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- age <14 years or ≥90 years;
- pregnancy;
- cancer with a life expectancy of less than one year;
- participation in other trials;
- endocarditis, pericardial diseases, or congenital heart diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
a composite of cardiovascular mortality or hospitalization due to subjectively and objectively worsening HF
Time frame: 5 years
An independent committee of experts including three physicians reviews all the death certificates and medical records for adjudicating the death cases and all suspected CVD cases biennially from the index episode, via telephone contacting patients' family members or reviewing medical records and the Hospital Discharge Register data.
2 secondary outcomes
cardiovascular mortality
Time frame: 5 years
hospitalization due to worsening HF
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 35501092Jin Y, Huang H, Zhou Q, Dong F, Lu L, Gao X, Wu Z. Prospective assessing metabolic abnormalities, lifestyle and dietary pattern in a Chinese population with heart failure: the MALD-HF study protocol. BMJ Open. 2022 May 2;12(5):e049225. doi: 10.1136/bmjopen-2021-049225.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhijun Wu, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Metabolic Disease, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhijun Wu, MD (008613818908053, totito19822005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite of cardiovascular mortality or hospitalization due to subjectively and objectively worsening HF (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.