NCT06455878 Mobile Applet for Weight Management in Obese Heart Failure Patients
| NCT ID | NCT06455878 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart Health Research Center |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 830 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 830 participants in total. It began in 2024-06-06 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this clinical trial is to investigate the effect of weight reduction through a diet management application and an intelligent weight scale on a composite cardiovascular endpoint in obese patients with heart failure. The main questions are: Does the use of a diet management APP and intelligent weight scale reduce 1-year all-cause mortality, heart failure hospitalization, and first heart failure hospital stay? Does the use of a diet management APP and intelligent weight scale improve the outcomes of assessment of heart failure frailty and quality of life for heart failure? Researchers will compare using the fully functional diet management app and intelligent weight scale to using the limitedly functional app and intelligent weight scale to see if the app works to improve heart failure conditions. Participants will: Use the diet management app at every meal and the intelligent weight scale every day for 12 months, and visit the clinic at 12 months for checkups.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years; 2. Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III; 3. Body mass index (BMI) ≥ 26 kg/m² or male waist-to-hip ratio (WHR=waist circumference/hip circumference) ≥ 0.9, female waist-to-hip ratio ≥ 0.85; 4. Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period; 5. History of heart failure hospitalization within the past 6 months; 6. Signed informed consent. Exclusion Criteria: 1. End-stage heart failure (≥2 hospitalizations for heart failure in the past 3 months, intolerance to guideline-directed medical therapy (GDMT), or dependence on inotropic agents); 2. Heart failure with reversible causes (e.g., peripartum cardiomyopathy, fulminant myocarditis); 3. Moderate or severe anemia (hemoglobin \[Hb\] \<90 g/L); 4. Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²) or ongoing dialysis; 5. Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure; 6. Alcohol or substance abuse; 7. Current use of weight-loss medications or planned bariatric surgery; 8. Malignancy with an expected survival \<1 year; 9. Conditions potentially hindering protocol compliance, as judged by the investigator (e.g., habitual reliance on food delivery services or company cafeteria meals); 10. Planned hospitalization during the trial period; 11. Concurrent participation in another interventional clinical study.
Contact & Investigator
Rong Han
STUDY DIRECTOR
Heart Health Research Center
Frequently Asked Questions
Who can join the NCT06455878 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06455878 currently recruiting?
Yes, NCT06455878 is actively recruiting participants. Contact the research team at zhao.yangyang@hhresearch.cn for enrollment information.
Where is the NCT06455878 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China, Langfang, China, Jixi, China and 11 additional locations.
Who is sponsoring the NCT06455878 clinical trial?
NCT06455878 is sponsored by Heart Health Research Center. The principal investigator is Rong Han at Heart Health Research Center. The trial plans to enroll 830 participants.
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