Treatment for Atrial Fibrillation

Phase-Based Estimates
3
Effectiveness
3
Safety
Maine Medical Center, Portland, ME
Atrial Fibrillation
Eligibility
18+
All Sexes
Eligible conditions
Atrial Fibrillation

Study Summary

This study is evaluating whether a drug may help reduce the number of episodes of atrial fibrillation.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of 12 months.

12 months
Mean minutes of activity per day
Mean percentage of time active each day
Mean percentage of time spent in atrial fibrillation
Mean quality of life score using the QualiTy-of-life (AFEQT) Questionnaire
Percentage of participants hospitalized for heart failure post catheter ablation of AF
Rate of health care utilization

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control Arm (Placebo)
Placebo group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Arm (Placebo)
Drug
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.
Intervention Management Arm (Dapagliflozin)
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
M. A.
Prof. Mehmet Aktas, Professor
University of Rochester

Closest Location

Maine Medical Center - Portland, ME

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
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.
You are scheduled to undergo ablation of symptomatic paroxysmal or persistent AF prior to date of randomization. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get atrial fibrillation a year in the United States?

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AF remains a rare condition and persists a significant burden to hospitals. Atrial fibrillation prevalence increases with age, but is also observed with increasing rates of obesity, HTN, and DM 2 in the U.S. population. Atrial fibrillation incidence is also increasing, but at a much lower rate than the incidence of all strokes.

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What are common treatments for atrial fibrillation?

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Sinus rhythm is common in heart transplantation and in some patients with valvular disease and may be treated with ACE inhibitors or beta blockers. Antiplatelet agents like aspirin with or without a thienopyridine such as clopidogrel are effective in reducing the risk of thromboembolization before cardiac surgery and myocardial infarction.

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What causes atrial fibrillation?

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These new methods have identified a new cause of the common disorder of sinus rhythm known as atrial fibrillation and have demonstrated how to treat this condition with new electrical devices.

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What are the signs of atrial fibrillation?

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Atrial fibrillation in the presence of clinically relevant mitral or tricuspid valve regurgitation can be reliably diagnosed from the ECG (98-99% sensitivity) alone. However, the presence of these anomalies alone raises only moderate concerns of embolic sources.

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What is atrial fibrillation?

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A fibrillation lasting more than 3 months seems to be associated with a low likelihood of cardioembolic stroke. In addition, a lower likelihood of TIA is found in AF subjects whose fibrillation is less than 2 weeks' duration or in those older than the fifth decade (age >55 yr) of age. Data from a recent study might help to guide preventive therapy for AF in the future.

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Can atrial fibrillation be cured?

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Yes, atrial fibrillation can sometimes be cured, but the chances that it will be cured are very slim. Most people with atrial fibrillation will require some treatment on an ongoing basis. If you are already receiving atrial function treatment, you can continue to receive it if this is the way you wish. Atrial function treatment can, however, only relieve some symptoms. In short, the cure of atrial fibrillation would be a miracle. Treating AF would eliminate all the problems associated with it. But this is not to discourage any people in good heart, even people who have already started receiving atrial function treatment and they still need to continue it.

Unverified Answer

What are the common side effects of treatment?

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All classes of antiarrhythmic drugs possess side effects. A number of side effects are frequently associated with the use of β-blockers, statins, and digoxin. Side effects vary widely depending on the route of administration and the drug dose applied. The most common side effects are gastrointestinal (nausea, vomiting), skeletal (osteonecrosis), and nervous (nervousness, tinnitus).

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What is the latest research for atrial fibrillation?

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Recent findings of this meta-analysis show that the use of concomitant medications and comorbid illnesses could be the most frequent risk factors for new-onset atrial fibrillation. However, more specifically, the type of atrial fibrillation has evolved to respond more to treatment.

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Have there been other clinical trials involving treatment?

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There are no clinical trials specifically designed for people with AFA. Given the high morbidity and mortality rates among people with AFA and the potential benefits from treatment, it is extremely important that randomized controlled trials be carried out in a timely manner.

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Is treatment safe for people?

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Treatment with warfarin is associated with a lower risk of periprocedural complications than with other anticoagulants. Atrial fibrillation is associated with a significantly increased risk of periprocedural bleeding.

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What does treatment usually treat?

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Although it was evident that the treatment used for AF would change over time, and the effects differed for different treatments, no consistent relationships could be demonstrated between the treatment and any specific effect. There is no evidence to define AF as a single disease entity, but rather as a group of related clinical syndromes and patterns of underlying remodelling.

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