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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Withdrawn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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Vivian and Seymour Milstein Family Heart CenterNew YorkUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.