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

NCT03536806 | Unknown Phase 4 DMC

• 1 other identifier: 2.62/VII/16
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation, Paroxysmal

Keywords

Pharmacological cardioversion; Canrenone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to conversion of atrial fibrillation to sinus rhythm.

  Time Frame: 2 hours.

• Atrial fibrillation recurrence within observation period.

  Time Frame: 2 hours.

• Serious adverse reactions.

  Time Frame: 24 hours.

• Safety outcome (exploratory analysis).

  Time Frame: 24 hours.

Study Arms (2)

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. Patients assigned to control group will be administered saline 0.9% in bolus of 10 cm3 within 2-3 minutes. After drug administration the patient will be observed for 2 hours after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient will depend on clinical condition and will follow appropriate clinical guidelines.

Drug: Saline 0.9%

Experimental: canrenone

EXPERIMENTAL

Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After administration of canrenone: dose 200 mg (1 ampule a 10 ml) within 2-3 minutes the patient will be observed for 2 hours after the dose with exit ECG and BP measure taken at the end of observation.

Drug: Canrenone

Interventions

Saline 0.9% DRUG

Patients assigned to control group will be administered saline 0.9% in bolus of 10 cm3 within 2-3 minutes. BP will be measured before injection.

Also known as: saline 0.9% in bolus of 10 cm3

Placebo Comparator: Placebo

Canrenone DRUG

Patients assigned to canrenone group will be administered canrenone in bolus of 200 mg diluted to 10 cm3 within 2-3 minutes in one dose. Drug administration will be stopped in case of serious adverse event. Further treatment of the patient will depend on clinical condition and will follow appropriate clinical guidelines.

Also known as: canrenone in bolus of 200 mg diluted to 10 cm3

Experimental: canrenone

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Related Publications (2)

• Dabrowski R, Segiet-Swiecicka A, Sawicki S, Kowalik I, Jaworski K, Farkowski M, Kubaszek-Kornatowska A, Michalek P, Dluzniewski M, Szwed H, Hryniewiecki T, Karwowski J; CANREN-AF investigators. Clinical Efficacy of Canrenone in Restoring Sinus Rhythm in Patients With Atrial Fibrillation-A Pilot, Randomized, Double-Blind Study. J Cardiovasc Pharmacol Ther. 2025 Jan-Dec;30:10742484251356361. doi: 10.1177/10742484251356361. Epub 2025 Jul 29.

  PMID: 40734383 DERIVED

• Dabrowski R, Syska P, Maczynska J, Farkowski M, Sawicki S, Kubaszek-Kornatowska A, Michalek P, Kowalik I, Szwed H, Hryniewiecki T. Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial). Trials. 2020 May 12;21(1):397. doi: 10.1186/s13063-020-04277-3.

  PMID: 32398047 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Sodium Chloride; Canrenone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Rafał Dąbrowski, MD, PhD

  Institute of Cardiology

  PRINCIPAL INVESTIGATOR

• Tomasz Hryniewiecki, MD, PhD

  Institute of Cardiology

  STUDY CHAIR

Central Study Contacts

Rafał Dąbrowski, MD, PhD

CONTACT

+48 601250732; rdabrowski45@gmail.com

Paweł Syska, MD, PhD

CONTACT

+48 604072667; psyskamd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rafal Dabrowski, MD, PhD

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 25, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: May 25, 2018

Record last verified: 2018-05