Atrial Fibrillation, Paroxysmal Clinical Trial
Official 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.
Canrenone is a specific antagonist of aldosterone. It is a competitive inhibitor of
aldosterone receptors and inhibits the effects of aldosterone. Spironolactone is a prodrug
which is active after its conversion into canrenone. By inhibiting the effects of aldosterone
it increases aqueous and sodium diuresis and is classified as a diuretic. It decreases
urinary elimination of potassium and increases urinary excretion of calcium. Canrenone is
used for the treatment of primary or secondary hyperaldosteronism, edema and ascites of
congestive heart failure and cirrhosis, and in the treatment of the arterial hypertension.
Current evidence supports renin-angiotensin-alodsterone (RAAS) inhibition:
angiotensin-converting-enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB) or,
potentially, mineralocorticoid receptor antagonists (MRA) as an upstream therapy for atrial
fibrillation (AF) management. It has been demonstrated that plasma aldosterone concentration
may be increased in patients with AF episode, and it lowers after cardioversion. Only
canrenone (potassium canrenoate) may be administered intravenously. Canrenone increases
plasma level of potassium, lowers blood pressure and reduces preload at the same time.
To show superiority of canrenone over placebo a sample size of 80 patients was calculated
based on following assumptions: two-tailed test, a type I error of 0.01, a power of 90%,
efficacy of placebo 5%, efficacy of canrenone 50% and 20% drop-out rate to fulfill the
criteria of intention-to-treat analysis. Due to presumed lack of statistical power the
secondary end points and safety endpoints will be considered exploratory.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04206917 -
MultiPulse Therapy (MPT) for AF
|
N/A |