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Atrial FibrillationPhase 4DAPA-AFNCT04792190

Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation

A Phase 4 study testing dapagliflozin in people with Atrial Fibrillation, run by University of Rochester at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 6-12 months of follow-up. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
3 sitesUnited States
Study dates
27 Jul 2021to 30 Jun 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Maine Medical Center

    Portland, Maine, 04102

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
dapagliflozin, Placebo
Keywords
Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dapagliflozinDrug

    Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.

  • PlaceboDrug

    Subjects will take 1 blinded capsule of placebo drug dosed once daily

Study groups in NCT04792190
Study groupRoleWhat they receive
Intervention Management Arm (Dapagliflozin)Active comparatorA 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.
Receives: Drug: dapagliflozin
Control Arm (Placebo)Placebo comparatorSubjects 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percentage of Time Spent in Atrial Fibrillation

    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).

    Measured: 12 months

Secondary outcomes (3)

  1. Rate of Health Care Utilization

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

    Measured: 6-12 months

  2. Percentage of Participants Hospitalized for Heart Failure Post Catheter Ablation of AF

    Measured: 6-12 months

  3. Mean Quality of Life Score Using the QualiTy-of-life (AFEQT) Questionnaire

    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.

    Measured: Final visit, approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start27 Jul 2021
  3. Primary completion31 Mar 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792190
Sponsor's protocol ID
00005844
Acronym
DAPA-AF
Status last verified
Nov 2024
First submitted
29 Jan 2021
Last updated
4 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

    PubMed 11343485

  • Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.

    PubMed 23831166

  • Jackson SL, Tong X, Yin X, George MG, Ritchey MD. Emergency Department, Hospital Inpatient, and Mortality Burden of Atrial Fibrillation in the United States, 2006 to 2014. Am J Cardiol. 2017 Dec 1;120(11):1966-1973. doi: 10.1016/j.amjcard.2017.08.017. Epub 2017 Aug 30.

    PubMed 28964382

  • Patel NJ, Deshmukh A, Pant S, Singh V, Patel N, Arora S, Shah N, Chothani A, Savani GT, Mehta K, Parikh V, Rathod A, Badheka AO, Lafferty J, Kowalski M, Mehta JL, Mitrani RD, Viles-Gonzalez JF, Paydak H. Contemporary trends of hospitalization for atrial fibrillation in the United States, 2000 through 2010: implications for healthcare planning. Circulation. 2014 Jun 10;129(23):2371-9. doi: 10.1161/CIRCULATIONAHA.114.008201. Epub 2014 May 19.

    PubMed 24842943

  • Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):313-20. doi: 10.1161/CIRCOUTCOMES.110.958165. Epub 2011 May 3.

    PubMed 21540439

  • January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.

    PubMed 24685669

  • Zimetbaum P. Antiarrhythmic drug therapy for atrial fibrillation. Circulation. 2012 Jan 17;125(2):381-9. doi: 10.1161/CIRCULATIONAHA.111.019927. No abstract available.

    PubMed 22249528

  • Gupta A, Perera T, Ganesan A, Sullivan T, Lau DH, Roberts-Thomson KC, Brooks AG, Sanders P. Complications of catheter ablation of atrial fibrillation: a systematic review. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1082-8. doi: 10.1161/CIRCEP.113.000768. Epub 2013 Nov 15.

    PubMed 24243785

  • Freeman JV, Tabada GH, Reynolds K, Sung SH, Liu TI, Gupta N, Go AS. Contemporary Procedural Complications, Hospitalizations, and Emergency Visits After Catheter Ablation for Atrial Fibrillation. Am J Cardiol. 2018 Mar 1;121(5):602-608. doi: 10.1016/j.amjcard.2017.11.034. Epub 2017 Dec 14.

    PubMed 29331355

  • Deshmukh A, Patel NJ, Pant S, Shah N, Chothani A, Mehta K, Grover P, Singh V, Vallurupalli S, Savani GT, Badheka A, Tuliani T, Dabhadkar K, Dibu G, Reddy YM, Sewani A, Kowalski M, Mitrani R, Paydak H, Viles-Gonzalez JF. In-hospital complications associated with catheter ablation of atrial fibrillation in the United States between 2000 and 2010: analysis of 93 801 procedures. Circulation. 2013 Nov 5;128(19):2104-12. doi: 10.1161/CIRCULATIONAHA.113.003862. Epub 2013 Sep 23.

    PubMed 24061087

  • Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

    PubMed 27042964

  • Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

    PubMed 25946280

  • Hosseini SM, Rozen G, Saleh A, Vaid J, Biton Y, Moazzami K, Heist EK, Mansour MC, Kaadan MI, Vangel M, Ruskin JN. Catheter Ablation for Cardiac Arrhythmias: Utilization and In-Hospital Complications, 2000 to 2013. JACC Clin Electrophysiol. 2017 Nov;3(11):1240-1248. doi: 10.1016/j.jacep.2017.05.005. Epub 2017 Aug 2.

    PubMed 29759619

  • Frustaci A, Chimenti C, Bellocci F, Morgante E, Russo MA, Maseri A. Histological substrate of atrial biopsies in patients with lone atrial fibrillation. Circulation. 1997 Aug 19;96(4):1180-4. doi: 10.1161/01.cir.96.4.1180.

    PubMed 9286947

  • De Jong AM, Maass AH, Oberdorf-Maass SU, Van Veldhuisen DJ, Van Gilst WH, Van Gelder IC. Mechanisms of atrial structural changes caused by stretch occurring before and during early atrial fibrillation. Cardiovasc Res. 2011 Mar 1;89(4):754-65. doi: 10.1093/cvr/cvq357. Epub 2010 Nov 11.

    PubMed 21075756

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dapagliflozin in people with Atrial Fibrillation, run by University of Rochester at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percentage of Time Spent in Atrial Fibrillation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792190, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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