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临床试验/NCT05174052
NCT05174052招募中3 期

Dapagliflozin in Patients With Atrial Fibrillation

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
28
试验地点
1
主要终点
The effect of Dapagliflozin on change in burden of atrial fibrillation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with DM
  • Paroxysmal AF

排除标准

  • 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

研究组 & 干预措施

Control Arm (Placebo)

Placebo Comparator

Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme.

干预措施: Placebo (Drug)

Intervention Arm (Dapagliflozin)

Active Comparator

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

干预措施: Dapagliflozin 10Mg Tab (Drug)

结局指标

主要结局

The effect of Dapagliflozin on change in burden of atrial fibrillation

时间窗: Baseline and 3 months

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.

次要结局

  • Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey(Baseline and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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