Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
Primary Purpose
Diabete Mellitus, Atrial Fibrillation
Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin 10Mg Tab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabete Mellitus
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with DM
- Paroxysmal AF
Exclusion Criteria:
- Type 1 DM,
- Symptoms of hypotension or systolic blood pressure <90mmHg,
- Severe renal impairment with eGFR<30mL/minute/1.73m2,
- History of lower limb amputation,
- Hypersensitivity to Dapagliflozin,
- Currently taking any SGLT2i,
- Pregnancy,
- Currently taking anti-arrhythmic drugs
- Undergoing catheter ablation will be excluded
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control Arm (Placebo)
Intervention Arm (Dapagliflozin)
Arm Description
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.
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
Outcomes
Primary Outcome Measures
The effect of Dapagliflozin on change in burden of atrial fibrillation
To determine the effect of Dapagliflozin on change in AF burden in patients with AF and DM. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months. The AF burden between Dapagliflozin vs Placebo will be compared.
Secondary Outcome Measures
Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey
To determine the effect of Dapagliflozin on change in quality of life in patients with AF and DM. AF Effect on Quality of Life Survey will be used to compare QOL between Dapagliflozin vs Placebo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05174052
Brief Title
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
Official Title
Dapagliflozin in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will investigate the effect of Dapagliflozin on atrial fibrillation (AF) burden. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months, quality of life (QOL) and validated echocardiographic indices of atrial myopathy. This knowledge will enable us to study the therapeutic potential of SGLT2i as a novel adjunct treatment for patients with DM and AF. Patients with paroxysmal AF (AF that terminates spontaneously or with intervention within seven days of onset) and DM and randomize them to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden will be used, measure of QOL with the help of AF Effect on Quality-of-life survey and perform an echocardiogram with measurement of left atrial volume index, left atrial strain and atrial tissue dopplers. All measurements will be performed at baseline and at study completion. The central hypothesis is that SGLT2i will lead to reduced AF burden that will translate into improvement in QOL, and the underlying mechanism is improvement in atrial myopathy.
Detailed Description
Patients with diabetes mellitus (DM) and atrial fibrillation (AF) represent a high-risk cohort that is at an increased risk of cardiovascular complications as compared to AF patients without DM. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. However, none of these clinical trials studied AF as a primary outcome. SGLT2i have multiple properties that can be protective against AF and the role of SGLT2i in preventing recurrent AF remains an important knowledge gap.
In this translational research proposal, we aim to fill this knowledge gap by studying the effect of Dapagliflozin on AF burden. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months, quality of life (QOL) and validated echocardiographic indices of atrial myopathy. This knowledge will enable us to study the therapeutic potential of SGLT2i as a novel adjunct treatment for patients with DM and AF. Patients with paroxysmal AF (AF that terminates spontaneously or with intervention within seven days of onset) and DM will be enrolled. Subjects will be randomized to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden, measure QOL with the help of AF Effect on Quality-of-life survey and perform an echocardiogram with measurement of left atrial volume index, left atrial strain and atrial tissue dopplers. All measurements will be performed at baseline and at study completion. Our central hypothesis is that SGLT2i will lead to reduced AF burden that will translate into improvement in QOL, and the underlying mechanism is improvement in atrial myopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Mellitus, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, double blind, placebo-controlled trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm (Placebo)
Arm Type
Placebo Comparator
Arm Description
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.
Arm Title
Intervention Arm (Dapagliflozin)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10Mg Tab
Intervention Description
Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will take 1 blinded capsule of placebo drug dosed once daily
Primary Outcome Measure Information:
Title
The effect of Dapagliflozin on change in burden of atrial fibrillation
Description
To determine the effect of Dapagliflozin on change in AF burden in patients with AF and DM. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months. The AF burden between Dapagliflozin vs Placebo will be compared.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey
Description
To determine the effect of Dapagliflozin on change in quality of life in patients with AF and DM. AF Effect on Quality of Life Survey will be used to compare QOL between Dapagliflozin vs Placebo.
Time Frame
Baseline and 3 months
Other Pre-specified Outcome Measures:
Title
Effect of Dapagliflozin on change in Validated Echocardiographic Indices & Biomarkers of Atrial Myopathy
Description
To determine the effect of Dapagliflozin on validated echocardiographic indices and biomarkers of atrial myopathy in patients with AF and DM. We will compare left atrial volume index (ml/m2), left atrial strain and atrial tissue dopplers (cm/s). All measurements will be performed at baseline and at study completion and compared between Dapagliflozin vs Placebo. We will measure brain natriuretic peptide and other biomarkers as well.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with DM
Paroxysmal AF
Exclusion Criteria:
Type 1 DM,
Symptoms of hypotension or systolic blood pressure <90mmHg,
Severe renal impairment with eGFR<30mL/minute/1.73m2,
History of lower limb amputation,
Hypersensitivity to Dapagliflozin,
Currently taking any SGLT2i,
Pregnancy,
Currently taking anti-arrhythmic drugs
Undergoing catheter ablation will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antwanya Shaw
Phone
405-271-9060
Email
Antwanya-Shaw-1@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Stout
Phone
405-271-9060
Email
Michael-H-Stout@ouhsc.edu
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antwanya Shaw
Phone
405-271-9060
Email
Antwanya-Shaw-1@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Zain Asad, MD
12. IPD Sharing Statement
Learn more about this trial
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
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