Inhibition of Aldosterone to Reduce Myocardial Diffuse Fibrosis in Patients With Paroxysmal and P… (NCT02764619) | Clinical Trial Compass
UnknownPhase 3
Inhibition of Aldosterone to Reduce Myocardial Diffuse Fibrosis in Patients With Paroxysmal and Persistent Atrial Fibrillation in Preventing Recurrent Episodes of Atrial Fibrillation
Denmark125 participantsStarted 2013-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine change (∆) in diffuse myocardial fibrosis between groups, assessed by cardiovascular magnetic resonance (CMR) T1 mapping.
Timeframe: Change from baseline at 12 months
2
Determine difference (α) in myocardial stiffness between groups, assessed by strain analysis.
Timeframe: At time of randomization, 6 and 12 months
3
Determine difference (β) in left atrial phasic function between groups, assessed by transthoracic echocardiography.