Clinical Efficacy of Potassium Canrenoate in Sinus Rhythm Restoration Among Patients With Atrial Fibrillation.

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of potassium canrenoate - canrenone in rapid conversion of atrial fibrillation to sinus rhythm.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cardiology, Warsaw, Poland
• Treatments: Canrenoic Acid; Canrenone

Criteria

Inclusion Criteria:

• written informed consent for enrolment

• patients aged between 40 and 75 years

• atrial fibrillation episode lasting for less than 48 hours, documented by the ECG

• potassium plasma levels < 4.5 mmol/l

• blood pressure > 120/80 mmHg

• stable cardiopulmonary status (according to attending physician's assessment)

• in case of left ventricle injury suspicion or unclear medical history of cardiac insufficiency, enrolment will be possible after echocardiographic examination

Exclusion Criteria:

• no written informed consent for enrollment

• allergy to canrenone

• cardiac insufficiency or LVEF (left ventricular ejection fraction) < 40%

• systolic BP < 120/80 mmHg

• history of canrenone treatment in the 30 days before enrollment

• average QRS rate > 160 p.m.

• advanced hepatic or renal failure

• history of acute coronary syndrome, CABG (coronary artery bypass grafting), TIA (transient ischemic attack) or stroke within the previous 30 days

• pre-excitation syndrome (which has not been treated with accessory pathway ablation).

• atrial fibrillation due to a valvular heart disease

• atrial fibrillation episode resulting in myocardial ischemia (chest pain, ischemic changes in the ECG)