Inhibition of Aldosterone to Reduce Myocardial Diffuse Fibrosis in Patients With Paroxysmal and Persistent Atrial Fibrillation in Preventing Recurrent Episodes of Atrial Fibrillation

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blinded, placebo-controlled study to evaluate the effect of spironolactone in addition to conventional treatment compared with placebo in patients with paroxysmal and persistent atrial fibrillation with preserved left ventricular ejection fraction by T1 mapping, structure and function of left atrium and ventricle assessed by transthoracic echocardiography and cardiac magnetic resonance (CMR), the number of recurrent episodes of atrial fibrillation and biomarkers measured in blood.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Svendborg Hospital
• Collaborators: Region of Southern Denmark; Takeda
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age, male or female.

• Paroxysmal or persistent atrial fibrillation on one occasion, detected on 12-lead ECG or Holter monitoring with atrial fibrillation episode lasting ≥ 30 seconds within last 12 months prior to the screening visit.

• Women with childbearing potency must use effective contraception (e.g. implants, hormonal depot injections, combined oral contraceptives, intra-uterine devices or vasectomized partner). Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.

• Written informed consent signed before any study-specific procedure.

Exclusion Criteria:

• Permanent AF.

• Previous radiofrequency ablation and / or previous surgical therapy of AF.

• Heart failure (New York Heart Association [NYHA] ≥ II or/and left ventricular ejection fraction [LVEF] less than 40%).

• Severe coronary artery disease (acute coronary syndrome (ACS) within 6 months prior to the screening visit, previous coronary artery bypass graft [CABG] or stabile angina pectoris classified with Canadian Cardiovascular Society [CCS] ≥II). The definition of ACS is from the current European Society of Cardiology (ESC) and American College of Cardiology (ACC) / American Heart Association (AHA) guidelines.

• Stroke or transient ischemic cerebral attack within 6 months prior to the screening visit.

• Pregnant women, breastfeeding women or women of childbearing potential not on adequate birth control.

• Presence of severe and hemodynamically significant valvular heart disease.

• Hepatic insufficiency classified as Child-Pugh B or C .

• Any disease that limits life expectancy to less than 1 year.

• Participation in another clinical trial, either within the last 30 days or ongoing.

• Morbus Addison.

• Ongoing therapy with class IC agents (flecainide, propafenone) or amiodarone, dronedarone sotalol.

• Chronic kidney disease (estimated glomerular filtration rate [eGFR] ≤ 45 ml/min/1,73 m2 [MDRD]).

• Intolerance or contradictions to spironolactone, i.e. latest product resume on Spirix®.

• Patients who are noncompliant with treatment.

• Mental disorders suspected to interact with study outcome or any other patient characteristics that may interfere with adherence to the study protocol, such as dementia, substance abuse.

• Any surgical or medical condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.

• Baseline serum potassium ≥ 5,0 mmol/l or serum sodium < 135 mmol/l. Note: one re-assessment of electrolytes is allowed.