Atrial Fibrillation, Paroxysmal Clinical Trial
— CANREN-AFOfficial title:
Clinical Efficacy of Potassium Canrenoate - Canrenone in Sinus Rhythm Restoration Among Patients With Atrial Fibrillation and Elevated Blood Pressure - a Pilot Randomized Controlled Trial.
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Institute of Cardiology, Warsaw, Poland |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conversion of atrial fibrillation to sinus rhythm. | Conversion of atrial fibrillation to sinus rhythm confirmed in standard 12-lead ECG during observation period after first iv bolus. | Time Frame: 2 hours. | |
Secondary | Time to conversion of atrial fibrillation to sinus rhythm. | Time to conversion of atrial fibrillation to sinus rhythm in minutes since injection. | Time Frame: 2 hours. | |
Secondary | Atrial fibrillation recurrence within observation period. | Atrial fibrillation recurrence within observation period. | Time Frame: 2 hours. | |
Secondary | Serious adverse reactions. | Serious adverse reactions, which refer to every event requiring admission to a hospital or extended observation. | Time Frame: 24 hours. | |
Secondary | Safety outcome (exploratory analysis). | hypotension < 90 mm Hg, cardiac conduction abnormalities, new arrhythmia occurrence, other | Time Frame: 24 hours. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04206917 -
MultiPulse Therapy (MPT) for AF
|
N/A |