NCT07460505Not yet recruiting
Mandibular Advancement to Reduce Ventricular Load and Improve Quality-of-life in Heart Failure
Mandibular Advancement to Reduce Ventricular Load and Improve Quality of Life in Heart Failure - a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
Heart failure with reduced ejection fraction (HFrEF) is a serious condition that limits daily activities and often leads to hospital stays and early death. Many patients with HFrEF also have obstructive sleep apnea (OSA), a common but often undiagnosed condition where breathing repeatedly stops during sleep. This causes drops in oxygen, poor sleep, and stress on the heart, which can make heart failure worse. The investigators are studying whether a device called a mandibular advancement device (MAD)-a mouthpiece worn during sleep that keeps the airway open-can help people with both HFrEF and moderate-to-severe OSA. This device is already approved to treat OSA and is often more comfortable and easier to use than a CPAP machine. In our study, 328 patients in Singapore will be randomly assigned to use either the MAD or a sham device that looks the same but doesn't move the jaw. They will wear the device for 12 months. We will measure changes in a blood marker linked to heart failure severity, as well as exercise ability, blood pressure, sleep quality, and hospital visits. The investigators hope this study will show that MAD is a simple and patient-friendly way to improve outcomes in people with heart failure.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 328 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- May 2026
- Primary completion date
- Apr 2031
- Lead sponsor
- National University Hospital, Singapore
- Diseases
- Heart failure
- NCT number
- NCT07460505
What you commit to
- Study type: Interventional
- Planned participants: 328
- From May 2026 to the primary completion date, Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are planning to have restorations, dental prostheses or implants done in the next 12 months
Other illness
- Specific HF etiologies, including hypertrophic cardiomyopathy with left ventricular outflow tract obstruction; pericardial disease; infiltrative or inflammatory myocardial disease; valvular heart disease with severe aortic or primary mitral regurgitation, moderate or severe aortic stenosis, any mitral stenosis requiring surgical repair, or active endocarditis
- Pre-existing temporomandibular joint problems, severe bruxism, and advanced periodontal disease (with mobility affecting MAD stability).
- Cardiac or cerebrovascular events in the past 6 months, including myocardial infarction, unstable angina leading to hospitalization, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease
- Current or planned mechanical circulatory support or heart transplantation Current or planned (within the next 6 months) hemodialysis or peritoneal dialysis
Other
- Known OSA and already on regular treatment
- Moderate or severe valvular stenosis or regurgitation
- Severe hypoxemia on polysomnography ODI \>60 or min SpO2 \<60%
- Contraindications to MAD: less than six teeth in each arch; inability to advance the mandible and open the jaw widely.
- Limited life expectancy (\< one year)
Who the study is looking for
- Age of at least 40 years old with the capacity to provide signed, written informed consent
- Ischemic or non-ischemic cardiomyopathy with a left ventricular ejection fraction of 20% to 40% in the previous 6 months
- Stable chronic HF with NYHA functional class I-III symptoms on maximally tolerated background therapy for at least 4 weeks
- NT-proBNP \>600 pg/mL (for participants in sinus rhythm) or \>900 pg/mL (for participants in atrial fibrillation) in the previous 6 months (same as leading HF trials)
- Agree to follow the study protocol
- Able and willing to undergo a hospital-based overnight polysomnography
Age in the registry: 40 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.