SGLT2-Inhibitors for Sleep Apnea in Heart Failure
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT04640493
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Heart Failure
- Sleep Disordered Breathing
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGIf patients have been diagnosed with SDB using the WatchPat device, they will start dapagliflozin. Repeat WatchPat SDB assessment will be performed after 3 and 6 months of continuous dapagliflozin therapy.
- WatchPat — DEVICEHF patients undergo SDB testing with the WatchPat device. (non-experimental)
Study Details
Heart Failure is a disease involving many different aspects of the human body, including changes in metabolism, the way the body produces and uses energy. Research shows that patients with heart failure often have a sleep disorder called sleep disordered breathing (SDB). It has been shown that SDB is associated with poor outcomes in heart failure patients, but the exact reason is unknown. It is likely that SDB leads to changes in metabolism and hormone status in the body, which is especially dangerous for heart failure patients. There is currently no treatment for SDB in heart failure patients. Recently, with Sodium glucose co-transporter 2 (SGLT2)-Inhibitors a new drug class has been approved for the treatment of advanced heart failure. This drug has effects on the metabolism in heart failure patients, among several other effects. This research project has the aim to investigate if SGLT2 inhibitors can help in the treatment of SDB, as many mechanisms of the drug overlap with the mechanisms how SDB develops. The drug has been approved by the FDA for the treatment of heart failure. The investigators want to study the effect of the drug on SDB by using a home sleep test called Watchpat, which has been approved to diagnose SDB.
Key Dates
- Start date
- Dec 31, 2023
- Status verified
- May 2024
- Primary completion
- Aug 31, 2025
- Completion
- Aug 31, 2025
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: SGLT2-SDBPatients with newly diagnosed SDB will be given dapagliflozin (standard dosage, 10mg)
Primary Outcome Measure
Change in Apnea-Hypopnea Index [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vivian and Seymour Milstein Family Heart Center | New York | New York | 10032 | - |
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