RECRUITING

Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dapagliflozin in Patients With Atrial Fibrillation

Quick Facts

Study Start:2022-06-01
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05174052

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with DM
  2. * Paroxysmal AF
  1. * Type 1 DM,
  2. * Symptoms of hypotension or systolic blood pressure \<90mmHg,
  3. * Severe renal impairment with eGFR\<30mL/minute/1.73m2,
  4. * History of lower limb amputation,
  5. * Hypersensitivity to Dapagliflozin,
  6. * Currently taking any SGLT2i,
  7. * Pregnancy,
  8. * Currently taking anti-arrhythmic drugs
  9. * Undergoing catheter ablation will be excluded

Contacts and Locations

Study Contact

Aurora Vera
CONTACT
405-271-8001
Aurora-Vera@ouhsc.edu
Natalia Wells-Serrano
CONTACT
405-271-4742
natalia-wellsserrano@ouhsc.edu

Principal Investigator

Zain Ul Abideen Asad, MD
PRINCIPAL_INVESTIGATOR
University of Oklahoma

Study Locations (Sites)

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Zain Ul Abideen Asad, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

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 Registration Dates

Study Start Date2022-06-01
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus
  • Atrial Fibrillation