Clinical trial

The Effect of Sodium Glucose Co-transporter 2 (SGLT2)-Inhibitors on Sleep Disordered Breathing in Heart Failure Patients

Name

AAAT2147

Description

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.

Trial arms

Trial start

2023-12-01

Estimated PCD

2025-08-01

Trial end

2025-08-01

Status

Withdrawn

Phase

Early phase I

Treatment

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.

Arms:

SGLT2-SDB

Other names:

FARXIGA

WatchPat

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

Arms:

SGLT2-SDB

Primary endpoint

Change in Apnea-Hypopnea Index

6 months

Change Berlin Questionnaire Categorization

6 months

Change in Epworth Sleepiness Scale

6 months

Eligibility criteria

Inclusion Criteria: * Consent-able adults * Diagnosis of heart failure * Diagnosis of SDB * No contraindication for taking dapagliflozin Exclusion Criteria: * Patients without heart failure * Patients without SDB * Contraindication for taking dapagliflozin (severe renal impairment, hemodialysis, or history of severe hypoglycemic episodes)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Study design is prospective, non-randomized, interventional (non-experimental) pre-post study', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-05-13

1 organization

1 drug

2 indications

Organization

Columbia University

Drug

Dapagliflozin

Indication

Congestive Heart Failure

Indication

Sleep Disordered Breathing