Status:
NOT_YET_RECRUITING
SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Lead Sponsor:
University Hospital, Caen
Conditions:
Atrial Fibrillation Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Introduction: There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that ...
Detailed Description
Introduction: There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that ...
Eligibility Criteria
Inclusion
- Male or female (since spironolactone is not recommended during pregnancy and breastfeeding, a highly sensitive pregnancy test (serum HCG) will be systematically carried out in women of childbearing age and information will be given to non-pregnant women at the time of inclusion to instruct them to use an effective method of contraception during all the study period. Effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal, or progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion or vasectomised partner, or sexual abstinence)
- Age \> 18 years
- Hypertension defined as current use of anti-hypertensive drugs for more than 12 months
- Paroxysmal or no long-standing persistent AF (as defined by the ESC guidelines) with at least 1 episode within the preceding 6 months
- Sinus rhythm at enrolment
- Patient signed consent
- Willing to comply with scheduled visits, as outlined in the protocol
- French speaking
- Recipients of the social security regime
Exclusion
- Contraindications to spironolactone therapy: pregnancy, breastfeeding, intolerance, hyperkalemia (\>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) \< 30 ml/min/1,73m² (per the CKD-EPI equation). Subjects with serum creatinine ≥2.5 mg/dl are also excluded even if their eGFR is ≥30 ml/min/1,73m²), Severe liver dysfunction.
- Patients already treated by other potassium sparing medication (amiloride, triamterene) or MRA (spironolactone, eplerenone, potassium canreonate, finerenone).
- Other MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia
- LVEF \< 40% obtained within 6 months prior to V0
- Planned atrial fibrillation ablation within 6 months after randomization
- Moderate-to-severe valvular heart disease
- Permanent AF or long-standing persistent AF as defined by the ESC guidelines
- AF on the ECG at the inclusion visit
- Previous left atrial ablation or previous maze or maze-like surgery
- Acute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis)
- Left atrium diameter \> 60 mm obtained within 6 months prior to V0
- Contraindication to oral anticoagulation therapy
- Patients with persistent bradycardia of less than 50 beats per minute, a PR interval of 0.2 second or more on ECG, second degree (or higher) atrioventricular block, and snus-node disease without an implanted pacemaker
- Hemodynamic instability and unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock
- A life expectancy of 1 years or less
- Patients included or planning to be included in another medical research protocol whose pharmacological and scientific rationales might interfere with the Sponsor trial
- Patients unable to complete the protocol follow-up
- Pregnant or nursing women
- Adults with protective measures (curatorship or tutorship) and vulnerable patients
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT06204640
Start Date
March 1 2024
End Date
January 1 2029
Last Update
January 12 2024
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