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Withdrawn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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    If 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 — DEVICE
    HF 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-SDB
    Patients 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)

FacilityCityStateZIPSite coordinators
Vivian and Seymour Milstein Family Heart CenterNew YorkNew York10032-

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