Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06168994 |
| Other study ID # |
Eplerenone in AF |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
May 20, 2027 |
Study information
| Verified date |
December 2023 |
| Source |
Assiut University |
| Contact |
Walid Abdellah |
| Phone |
01158931616 |
| Email |
walidshehata573[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to study synergistic effect of eplerenone as Selective aldosterone
receptor antagonist with amiodarone compared with amiodarone only in reducing recurrence of
atrial fibrillation in patient with structural heart disease
Description:
Atrial fibrillation is the most common sustained arrhythmia, with a rising prevalence that
substantially increases the risk of stroke and heart failure (1,2), The rate of recurrences
without antiarrhythmic treatment is 71%-84%, and it can be reduced to 44%-67% with
antiarrhythmic drug therapy(3) Mineralocorticoid receptor blockers (MRBs) are beneficial in
systolic HF[ 4,5,6]. Specifically, the MRB eplerenone (EPL) has been shown to reduce new
onset AF and recurrent AF in HF patients (7). Both angiotensin II and aldosterone elevations
may lead to atrial fibrosis and contribute to human AF (8). Experimental results suggest that
aldosterone may cause a substrate for atrial fibrosis and AF (9). Aldosterone increases the
expression of 11β-hydroxysteroid dehydrogenase type 2 (11b-HSD2) leading to up-regulation of
profibrotic mediators and collagen synthesis, which is prevented by MRBs (10).
The European Society of Cardiology (ESC) guidelines identify AF as secondary to Structural
heart diseases (SHDs)when a left ventricle (LV) systolic or diastolic dysfunction is
demonstrated or LV hypertrophy, valvular disease, and/or other SHDs are documented
[11].currently, SHD includes: (a) heart failure with reduced ejection fraction (HFrEF,
previously severe or moderate LV systolic dysfunction); (b) heart failure with preserved
ejection fraction (HFpEF, previously LV diastolic dysfunction); (c) valvular heart disease
(VHD) and (d) specific cardiomyopathies, such as hypertrophic cardiomyopathy (HCM) [12].
Electrical remodelling is the first mechanism that occurs at the onset of AF and promotes AF
through a re-entry-prone substrate. Changes in atrial frequency are determined by changes in
the physiology of ion channel activation[13] Amiodarone is an antiarrhythmic medication used
to treat and prevent a number of types of cardiac dysrhythmias,it blocks the channels that
are upregulated by remodelling such as inward-rectifying K1 current (IK1) or by stimulation
of the sympathetic nervous system.[14]
