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SGLT2-Inhibitor

SGLT2-Inhibitors for Sleep Apnea in Heart Failure

Phase 2
Waitlist Available
Led By Nir Uriel, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No contraindication for taking dapagliflozin
Consent-able adults
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is investigating whether a new drug class called Sodium glucose co-transporter 2 (SGLT2)-Inhibitors can help in the treatment of sleep disordered breathing.

Who is the study for?
This trial is for adults who can consent, have been diagnosed with heart failure and sleep disordered breathing (SDB), and have no issues that would prevent them from taking dapagliflozin. People cannot join if they have severe kidney problems, need hemodialysis, or have had serious low blood sugar events.Check my eligibility
What is being tested?
The study is testing whether a drug called Dapagliflozin can treat SDB in patients with heart failure. It's already approved for advanced heart failure due to its effects on metabolism. Participants will use a home sleep test named WatchPat to monitor the effectiveness of the treatment.See study design
What are the potential side effects?
Dapagliflozin may cause dehydration, urinary tract infections, genital yeast infections, increased cholesterol levels, and potentially lower blood pressure which could lead to dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can safely take dapagliflozin without health risks.
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I am an adult who can legally consent.
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I have been diagnosed with sleep-disordered breathing.
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I have been diagnosed with heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change Berlin Questionnaire Categorization
Change in Apnea-Hypopnea Index
Change in Epworth Sleepiness Scale

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: SGLT2-SDBExperimental Treatment2 Interventions
Patients with newly diagnosed SDB will be given dapagliflozin (standard dosage, 10mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64880

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,424 Previous Clinical Trials
2,473,007 Total Patients Enrolled
Nir Uriel, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
410 Total Patients Enrolled

Media Library

Dapagliflozin (SGLT2-Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04640493 — Phase 2
Sleep Apnea Research Study Groups: SGLT2-SDB
Sleep Apnea Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT04640493 — Phase 2
Dapagliflozin (SGLT2-Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04640493 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions does Dapagliflozin commonly target?

"Dapagliflozin is effective in managing pharmaceutical preparations, diet, and exercise."

Answered by AI

Is it possible to still sign up for this clinical trial?

"This particular trial is not recruiting patients at the moment, as noted by the last update to the listing on 3/8/2022. However, there are 1091 trials for heart failure and 67 studies involving Dapagliflozin that are actively seeking candidates."

Answered by AI

When was Dapagliflozin cleared by the FDA for public use?

"Dapagliflozin's safety is based on phase 2 trial data, meaning that while there is some evidence backing its safety, none exists yet for its efficacy."

Answered by AI

Is this a groundbreaking medical study?

"There are 67 ongoing clinical trials worldwide for the medication dapagliflozin. The first study was conducted in 2014 by AstraZeneca and completed the N/A drug approval stage with 700 patients. In the 6 years since, 175 more studies have completed."

Answered by AI

How many people are currently enrolled in this experiment?

"This study is no longer recruiting patients for participation. The trial was first posted on 4/1/2022 and ended recruitment on 3/8/2022. However, there are other ongoing studies that may be of interest. There are 1091 clinical trials actively searching for patients with heart failure and 67 studies for Dapagliflozin that are still recruiting participants."

Answered by AI
~13 spots leftby Aug 2025