NCT04640493WithdrawnPhase 2
SGLT2-Inhibitors for Sleep Apnea in Heart Failure
The Effect of Sodium Glucose Co-transporter 2 (SGLT2)-Inhibitors on Sleep Disordered Breathing in Heart Failure Patients
Source: ClinicalTrials.gov · Last updated 13 May 2024
Reason given: Lack of enrollment
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 17 Nov 2020
- Start date
- Dec 2023
- Primary completion date
- Aug 2025
- Lead sponsor
- Columbia University
- Diseases
- Heart failure
- NCT number
- NCT04640493
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients without heart failure
- Contraindication for taking dapagliflozin (severe renal impairment, hemodialysis, or history of severe hypoglycemic episodes)
Other
- Patients without SDB
Who the study is looking for
- Consent-able adults
- Diagnosis of heart failure
- Diagnosis of SDB
- No contraindication for taking dapagliflozin
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vivian and Seymour Milstein Family Heart Center | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.