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

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT04792190
Collaborator
AstraZeneca (Industry)
100
Enrollment
5
Locations
2
Arms
34.2
Anticipated Duration (Months)
20
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 100 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 100 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 12 months following catheter ablation of AF. We expect that each participating site will enroll a 12-14 patients during a 24-month period. The Investigational Drug Services at the University of Rochester will be in charge of dispensing all study related drugs to subject.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 27, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean percentage of time spent in atrial fibrillation [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 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).

Secondary Outcome Measures

  1. Rate of health care utilization [12 months]

    Rate of health care utilization (recurrent hospitalizations, unplanned office visits, need for emergency room visits)

  2. Percentage of participants hospitalized for heart failure post catheter ablation of AF [12 months]

  3. Mean quality of life score using the QualiTy-of-life (AFEQT) Questionnaire [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.

  4. Mean minutes of activity per day [12 months]

    Modern cardiac implantable electronic devices (CIED) have built-in accelerometers which can be used to measure patient activity in number of minutes active each day or percent active per day. CIED derived activity data defined as minutes of activity or percent of time active each day will be collected.

  5. Mean percentage of time active each day [12 months]

    Modern cardiac implantable electronic devices (CIED) have built-in accelerometers which can be used to measure patient activity in number of minutes active each day or percent active per day. CIED derived activity data defined as minutes of activity or percent of time active each day will be collected.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maine Medical Center Portland Maine United States 04102
2 Massachusetts General Hospital Boston Massachusetts United States 02114
3 Henry Ford Hospital Detroit Michigan United States 48202
4 University of Rochester Medical Center Rochester New York United States 14642
5 St. Luke's Hospital and Health Network Bethlehem Pennsylvania United States 18018

Sponsors and Collaborators

  • University of Rochester
  • AstraZeneca

Investigators

  • Principal Investigator: Mehmet Aktas, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mehmet Aktas, Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT04792190
Other Study ID Numbers:
  • 00005844
First Posted:
Mar 10, 2021
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Mehmet Aktas, Professor, University of Rochester
Atrial Fibrillation
Additional relevant MeSH terms:
Atrial Fibrillation
Dapagliflozin

Study Results

No Results Posted as of Apr 22, 2022