Paroxysmal Atrial FibrillationPhase 4NCT06168994
Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patient With Structural Heart Disease
A Phase 4 study testing Eplerenone in people with Paroxysmal Atrial Fibrillation, run by Assiut University.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 20 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- paroxysmal AF who reverted to sinus rhythm either medically or electrically without appropriate secondary cause of primary AF
- •AF attack should be documented with ECG
Who cannot join
- 1-patients are currently on eplerenone or spironolactone 2-hyperkalemia 3-impaired renal function(if CrCl <50ml/min or serum creatinine>2 mg/dl) 4-patient on beta blocker and calcium channel blocker (non- dihydropyridine) 5-prosthetic valve 6-severe mitral stenosis 7-thyroid dysfunction 8-WPW 9-severe liver disease 10-persistent or permanent AF 11-pregnancy or breast feeding 12-LV EF<50% 13-known hypersensitivity or drug reaction to amiodarone 14-acute coronary syndrome 15-refusal of consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hatem Helmy contact
About this study
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
Read the detailed 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]
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Eplerenone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Amiodarone vs eplerenone in AF
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone as comparison | Active comparator | 50 patients >>Amiodarone +other treatmen Receives: Drug: Eplerenone |
| Eplerenone plus amiodarone | Experimental | 50 patients >>Amiodarone +other treatmen Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of eplerenone in reducing recurrence of atrial fibrillation in patient with structural heart disease
decrease recurrence of paroxysmal AF in patient of structural heart disease
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion29 Sep 2026 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Shehata Ahmed abdellah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168994
- Sponsor's protocol ID
- Eplerenone in AF
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patient With Structural Heart Disease
- ClinicalTrials.gov ID
- NCT06168994
- Acronym / sponsor ID
- Eplerenone in AF
- Conditions
- Paroxysmal Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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]
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone as comparison | Active comparator | Drug: Eplerenone50 patients >>Amiodarone +other treatmen |
| Eplerenone plus amiodarone | Experimental | Drug: Eplerenone50 patients >>Amiodarone +other treatmen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- paroxysmal AF who reverted to sinus rhythm either medically or electrically without appropriate secondary cause of primary AF
- •AF attack should be documented with ECG
Key exclusion criteria (1 listed)
- 1-patients are currently on eplerenone or spironolactone 2-hyperkalemia 3-impaired renal function(if CrCl <50ml/min or serum creatinine>2 mg/dl) 4-patient on beta blocker and calcium channel blocker (non- dihydropyridine) 5-prosthetic valve 6-severe mitral stenosis 7-thyroid dysfunction 8-WPW 9-severe liver disease 10-persistent or permanent AF 11-pregnancy or breast feeding 12-LV EF<50% 13-known hypersensitivity or drug reaction to amiodarone 14-acute coronary syndrome 15-refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplerenoneAmiodarone vs eplerenone in AF | Drug | Amiodarone as comparison, Eplerenone plus amiodarone |
Primary outcome
Role of eplerenone in reducing recurrence of atrial fibrillation in patient with structural heart disease
Time frame: Baseline
decrease recurrence of paroxysmal AF in patient of structural heart disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatem Helmy contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eplerenone in people with Paroxysmal Atrial Fibrillation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walid Abdellah (01158931616, walidshehata573@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of eplerenone in reducing recurrence of atrial fibrillation in patient with structural heart disease (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.