Hypertensive patients > 18 years referred for documented AF episodes (symptomatic or not) with preserved left ventricular ejection fraction (LVEF). MedDRA version: 21.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866
Conditions
Interventions
Trade Name: SPIRONOLACTONE
Product Name: SPIRONOLACTONE
Pharmaceutical Form: Tablet
Sponsors
CHU CAEN Normandie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female; 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 580 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 580
Exclusion criteria
Exclusion criteria: Contraindications to spironolactone therapy: intolerance, hyperkalemia (>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether administration of spironolactone (25 mg per day initially, titrated to a maximum of 50 mg per day) on top of standard therapy, leads to a reduction in the recurrence of documented AF episodes (symptomatic or not) occurring from randomization and within 12 months, compared with standard therapy alone, in hypertensive patients with preserved LVEF;Secondary Objective: To evaluate whether spironolactone administration affects: - Symptomatic documented AF occurring from randomization and within 12 months, - The time of recurrence of the first documented AF episode (symptomatic or not), from randomization and within 12 months, - The cumulative recurrence rate of AF from randomization and within 12 months, - Major cardiovascular events and death (all-cause mortality, stroke, myocardial infarction, heart failure) occurring from randomization and within 12 months, - The rate of cerebral/systemic thrombo-embolic and bleeding events, - Mean ventricular rate at the recurrence of AF, - Blood pressure reduction and control, - Safety parameters, particularly blood pressure, serum potassium levels and renal function from randomization and within 12 months. - To constitute a biobank for future ancillary studies ;Primary end point(s): First documented recurrence of AF occurring from randomization and within 12 months, defined as an episode lasting for at least 30 sec documented on 12-leads ECG (planned or not) or on extended holter monitor (Cardioskin Lite®, Bioserenity, Inc.).;Timepoint(s) of evaluation of this end point: 12 mois | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 12 mois | — |
Countries
France
Contacts
Public ContactCoordinating investigator
CHU CAEN Normandie
Outcome results
None listed