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New treatment option for Heart Failure
Official title Mobile Applet for Weight Management in Obese Heart Failure Patients
ClinicalTrials.gov ID: NCT06455878
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥18 years;
- Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III;
- 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;
- Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period;
- History of heart failure hospitalization within the past 6 months;
You likely can't join if
- End-stage heart failure (≥2 hospitalizations for heart failure in the past 3 months, intolerance to guideline-directed medical therapy (GDMT), or...
- Heart failure with reversible causes (e.g., peripartum cardiomyopathy, fulminant myocarditis);
- Moderate or severe anemia (hemoglobin [Hb] \<90 g/L);
- Renal insufficiency (estimated glomerular filtration rate [eGFR] \<30 mL/min/1.73 m²) or ongoing dialysis;
- Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
- Alcohol or substance abuse;
See the full eligibility criteria
- Age ≥18 years;
- Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III;
- 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;
- Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period;
- History of heart failure hospitalization within the past 6 months;
- Signed informed consent.
- 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);
- Heart failure with reversible causes (e.g., peripartum cardiomyopathy, fulminant myocarditis);
- Moderate or severe anemia (hemoglobin [Hb] \<90 g/L);
- Renal insufficiency (estimated glomerular filtration rate [eGFR] \<30 mL/min/1.73 m²) or ongoing dialysis;
- Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
- Alcohol or substance abuse;
- Current use of weight-loss medications or planned bariatric surgery;
- Malignancy with an expected survival \<1 year;
- Conditions potentially hindering protocol compliance, as judged by the investigator (e.g., habitual reliance on food delivery services or company cafeteria meals);
- Planned hospitalization during the trial period;
- Concurrent participation in another treatment clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Langfang, Hebei, China
- Jixi, Heilongjiang, China
- Luoyang, Henan, China
- Shangqiu, Henan, China
- Xinyang, Henan, China
- Zhengzhou, Henan, China
- Tongliao, Inner Mongolia, China
- Anshan, Liaoning, China
- Diaobingshancun, Liaoning, China
- Shenyang, Liaoning, China
- Pingdu, Shandong, China
- Taian, Shandong, China
- Weihai, Shandong, China
- Changzhi, Shanxi, China
- Xian, Shanxi, China
- Yulin, Shanxi, China
- Ürümqi, The Xinjiang Uygur Autonomous Region, China
- Taizhou, Zhejiang, China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Langfang, Hebei, China; Jixi, Heilongjiang, China; Luoyang, Henan, China; Shangqiu, Henan, China and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.