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SGLT2-Inhibitors for Sleep Apnea in Heart Failure

NCT04640493 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dapagliflozin

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.

DEVICE

WatchPat

HF patients undergo SDB testing with the WatchPat device. (non-experimental)

Sponsors & Collaborators

Principal Investigators

  • Nir Uriel, MD · Columbia University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640493 on ClinicalTrials.gov