SGLT2-Inhibitors for Sleep Apnea in Heart Failure

NCT04640493 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: AAAT2147
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; Sleep Disordered Breathing

Keywords

heart failure; sleep disordered breathing; sglt2-inhibitor; sglt2; dapagliflozin; watchpat

Outcome Measures

Primary Outcomes (3)

• Change in Apnea-Hypopnea Index

  Change in the apnea-hypopnea index as measured by the WatchPAT device.

  6 months

• Change Berlin Questionnaire Categorization

  The Berlin Questionnaire for sleep apnea consists of 3 categories related to the risk of having sleep apnea. Participants are classified as "High Risk" or "Low Risk" for sleep apnea. High risk categorization is assigned when there are 2 or more categories where the score is positive ("positive" defined as a score of 2 or more points). Low risk categorization is assigned when there is 1 or no categories where the score is positive.

  6 months

• Change in Epworth Sleepiness Scale

  The Epworth Sleepiness Scale is an 8-item scale measuring sleepiness in various situations. Each situation is scored as 0=no chance of dozing to 3= high chance of dosing. Scores range from 0-24, with a higher score indicating a higher level of sleepiness.

  6 months

Study Arms (1)

SGLT2-SDB

EXPERIMENTAL

Patients with newly diagnosed SDB will be given dapagliflozin (standard dosage, 10mg)

Drug: Dapagliflozin; Device: WatchPat

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.

Also known as: FARXIGA

SGLT2-SDB

WatchPat DEVICE

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

SGLT2-SDB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent-able adults
• Diagnosis of heart failure
• Diagnosis of SDB
• No contraindication for taking dapagliflozin

You may not qualify if:

• Patients without heart failure
• Patients without SDB
• Contraindication for taking dapagliflozin (severe renal impairment, hemodialysis, or history of severe hypoglycemic episodes)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Vivian and Seymour Milstein Family Heart Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Nir Uriel, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study design is prospective, non-randomized, interventional (non-experimental) pre-post study

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: December 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)