Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (DAPA-AF)

August 9, 2023 updated by: Mehmet Aktas, University of Rochester

Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (DAPA-AF) Prospective, Randomized, Multicenter, Placebo-Controlled Trial

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of atrial fibrillation (AF) on the burden of AF during 6-12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 25 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of AF on the burden of AF during 6-12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 25 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients. All enrolled subjects will be required to have a cardiac implantable electronic device (CIED) capable of assessing the burden of AF. Following catheter ablation for AF and functional CIED subjects will be randomized to treatment with dapagliflozin 10 mg once daily versus placebo. The primary endpoint for the trial will be AF burden assessed at 6-12 months following catheter ablation of AF. The Investigational Drug Services at the University of Rochester will be in charge of dispensing all study related drugs to subject.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Eligible for treatment with dapagliflozin per current FDA-approved indications, including: 1) heart failure (NYHA class II-IV) with reduced left ventricular ejection fraction (<50%), or 2) type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors, or 3) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, 4) adults with chronic kidney disease at risk of progression as defined by the National Kidney Foundation as estimated GFR <60 ml/minute/1.73 m2.
  • Scheduled to undergo ablation of symptomatic paroxysmal or persistent AF prior to date of randomization per current guideline indications.
  • A glycated hemoglobin level < 10.5% during the past 6 calendar months prior to consent only in patients with type 2 diabetes mellitus
  • Age > 18 years
  • Existing functional CIED or planned to undergo CIED implant as SOC before or within 24 hours following the AF ablation procedure and prior to randomization date.

Exclusion Criteria

  • Type 1 diabetes mellitus
  • History of diabetic keto-acidosis
  • Child Pugh Class C liver disease
  • Last measured estimated GFR < 25 ml/minute/1.73 m2
  • Pregnancy, plan to become pregnant <1 year after consent or breast feeding
  • Current therapy with an SGLT2 inhibitor
  • Hypersensitivity to dapagliflozin
  • On heart transplant list or likely to undergo heart transplant
  • Unwilling or unable to cooperate with the protocol
  • Participation in other clinical trials (observational registries are allowed with approval).
  • Unwilling to sign the consent for participation
  • Life expectancy <1 year after consent date for any medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Management Arm (Dapagliflozin)
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Drug: dapagliflozin
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
Placebo Comparator: Control Arm (Placebo)
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Drug: Placebo
Subjects will take 1 blinded capsule of placebo drug dosed once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean percentage of time spent in atrial fibrillation
Time Frame: 6-12 months

For the primary endpoint of AF burden, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a patient was monitored), the student's t-test will be used to statistically compare the placebo group vs. the active treatment group. This approach is subject to an examination of the distribution of the percent time in AF. AF data will be collected using a cardiac implantable electronic device (CIED).

AF burden assessed at 6-12 months following catheter ablation of AF, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a subject was monitored).
6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of health care utilization
Time Frame: 6-12 months
Rate of health care utilization (recurrent hospitalizations, unplanned office visits, need for emergency room visits)
6-12 months
Percentage of participants hospitalized for heart failure post catheter ablation of AF
Time Frame: 6-12 months
6-12 months
Mean quality of life score using the QualiTy-of-life (AFEQT) Questionnaire
Time Frame: 6-12 months
The AFEQT questionnaire is an AF-specific health-related quality of life questionnaire designed to be used in clinical research. The responses on the AFEQT are scored on a Likert scale, 1 = "Not at all…" to 7 = "Extremely". Scores range from 0 to 100. A score of 0 corresponds to complete disability and a score of 100 corresponds to no disability.
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Mehmet Aktas, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00005844

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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