Suppression of the hormone aldosterone to diminish scar tissue in heart in patients with atrial fibrillatio

Phase 1

• Conditions: Paroxysmal and persistent atrial fibrillation; MedDRA version: 18.1Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 100000004849; MedDRA version: 18.1Level: LLTClassification code 10066664Term: Recurrent symptomatic atrial fibrillationSystem Organ Class: 100000004849; MedDRA version: 18.1Level: LLTClassification code 10003661Term: Atrial fibrillation paroxysmalSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000797-30-DK
• Lead Sponsor: Department of Medical Research, Odense University Hospital, Svendborg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-08
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients = 18 years of age, male or female.
Signed written informed consent.
Paroxysmal atrial fibrillation on one or more occasions, detected on 12-lead ECG or Holter monitoring with each AF-episode lasting = 30 seconds, within the last 12 months prior to the screening visit, or persistent AF on one or more occasions that has been direct current (DC) cardioverted within the last 12 months prior to the screening visit.
Patients with CHA2DS2-VASc score = 1 will be encouraged to start anticoagulant treatment, but will not be excluded if there are reasonable reasons not to, i.e. risk of bleeding. Patients can choose between standard anticoagulation therapies, i.e. warfarin or non vitamin-K oral anticoagulants (NOAC) such as dabigatran, apixaban and rivaroxaban.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Chronic atrial fibrillation.
Previous radiofrequency ablation for atrial fibrillation or previous surgical treatment of atrial fibrillation, i.e. MAZE or His-ablation.
Heart failure (New York Heart Association (NYHA) class = II and/or LVEF less than 40%).
Severe coronary artery disease (acute myocardial infarction within 6 months prior to the screening visit, previous coronary artery bypass graft (CABG) or stabile angina pectoris (Canadian Cardiovascular Society (CCS) class =II).
Stroke or transient ischemic cerebral attack within 6 months prior to the screening visit.
Pregnant women or women of childbearing potential not on adequate birth control. Only women with a highly effective method of contraception (oral contraception, intra-uterine device or sterile women) can be randomized.
Presence of severe and hemodynamically significant valvular heart disease.
Any disease that limits life expectancy to less than 1 year.
Hepatic insufficiens classified as Child-Pugh B or C.
Participation in another clinical trial, either within the last 30 days or ongoing.
Breastfeeding women.
Ongoing therapy with class IC antiarrhythmics (flecainide, propafenone), amiodarone, dronedarone or sotalol.
Chronic or acute kidney disease (estimated glomerular filtration rate (eGFR) = 45 ml/min/1,73m2 (4-variable MDRD equation)).
Baseline serum potassium > 5,0 mmol/l.
Intolerance or contradictions to spironolactone, i.e. latest product information on Spirix®.
Intolerance or contradictions to dabigatran (Pradaxa®) i.e. latest product information.
Patients who are noncompliant to the medical treatment.
Atrial fibrillation that is associated with an acute reversible condition, i.e. heart surgery, untreated hyperthyroidism etc.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified