Micronised spironolactone (spironolactone) for Atrial fibrillation with preserved left ventricular ejection fraction | Hypertension

Inclusion criteria

• {"criterion_text":"- □\tMale 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)"}
• {"criterion_text":"- □\tRecipients of the social security regime"}
• {"criterion_text":"- □\tAge ≥18 years"}
• {"criterion_text":"- □\tHypertension defined as current use of anti-hypertensive drugs for more than 12 months"}
• {"criterion_text":"- □\tParoxysmal or no long-standing persistent AF (as defined by the ESC guidelines) with at least 1 episode within the preceding 12 months"}
• {"criterion_text":"- □\tSinus rhythm at enrolment"}
• {"criterion_text":"- □\tPatients with a smartphone (Android or iPhone)"}
• {"criterion_text":"- □\tPatient signed consent"}
• {"criterion_text":"- □\tWilling to comply with scheduled visits, as outlined in the protocol"}
• {"criterion_text":"- □\tFrench speaking"}

Exclusion criteria

• {"criterion_text":"- □\tContraindications to spironolactone therapy: pregnancy, breastfeeding, intolerance, hyperkalemia (≥ 5 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 50 ml/min/1,73m² (per the CKD-EPI equation). Severe liver dysfunction"}
• {"criterion_text":"- □\tAcute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis)"}
• {"criterion_text":"- □\tLeft atrium diameter > 60 mm obtained within 6 months prior to V0"}
• {"criterion_text":"- □\tPatients with persistent bradycardia of less than 50 beats per minute or a PR interval of 0.2 second or more on ECG, or second degree (or higher) atrioventricular block, or sinus-node disease without an implanted pacemaker"}
• {"criterion_text":"- □\tHemodynamic instability and unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock"}
• {"criterion_text":"- □\tA life expectancy of 1 years or less"}
• {"criterion_text":"- □\tPatients included or planning to be included in another medical research protocol whose pharmacological and scientific rationales might interfere with the Sponsor trial"}
• {"criterion_text":"- □\tPatients unable to complete the protocol follow-up"}
• {"criterion_text":"- □\tPregnant or nursing women"}
• {"criterion_text":"- □\tAdults with protective measures (curatorship or tutorship) and vulnerable patients"}
• {"criterion_text":"- □\tPatients already treated by other potassium sparing medication (amiloride, triamterene) or MRA (spironolactone, eplerenone, potassium canreonate, finerenone)"}
• {"criterion_text":"- □\tOther MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia"}
• {"criterion_text":"- □\tLVEF < 40% obtained within 6 months prior to V0"}
• {"criterion_text":"- □\tPlanned atrial fibrillation ablation within 6 months after randomization"}
• {"criterion_text":"- □\tModerate-to-severe valvular heart disease"}
• {"criterion_text":"- □\tPermanent AF or long-standing persistent AF as defined by the ESC guidelines"}
• {"criterion_text":"- □\tAF on the ECG at the inclusion visit"}
• {"criterion_text":"- □\tPrevious left atrial ablation or previous maze or maze-like surgery"}

Primary endpoints

• {"endpoint_text":"- 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 a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings)","definition_or_measurement_approach":"Defined as an episode lasting for at least 30 seconds documented on 12-leads ECG (planned or not) or on a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings) occurring from randomization within 12 months."}

Secondary endpoints

• {"endpoint_text":"- The recurrence of symptomatic documented AF episodes from randomization and within 12 months","definition_or_measurement_approach":"Recurrence of symptomatic AF episodes documented (method not further specified) from randomization within 12 months."}
• {"endpoint_text":"- The delay (days) of recurrence of the first documented AF episode (symptomatic or not) during the follow-up","definition_or_measurement_approach":"Time in days to first documented AF episode (symptomatic or not) during follow-up."}
• {"endpoint_text":"- The cumulative AF burden defined as the percentage of time in irregular rhythm on the wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings) from randomization and within 12 months","definition_or_measurement_approach":"Cumulative AF burden measured as percentage of time in irregular rhythm on the wearable PPG device (ScanWatch 42mm®, Withings) from randomization within 12 months."}
• {"endpoint_text":"- Composite of major cardiovascular events and death (death from any cause, stroke, heart failure, myocardial infarction) occurring from randomization and within 12 months","definition_or_measurement_approach":"Composite of major cardiovascular events and all-cause death occurring from randomization within 12 months (events defined as death, stroke, heart failure, myocardial infarction)."}
• {"endpoint_text":"- Occurrence of cerebral/systemic thrombo-embolic and bleeding events","definition_or_measurement_approach":"Occurrence of cerebral/systemic thrombo-embolic and bleeding events during follow-up (no additional measurement detail provided)."}
• {"endpoint_text":"- Mean ventricular rate (beats per minute) at the recurrence of AF on 12-leads ECG (planned or not) or on a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings)","definition_or_measurement_approach":"Mean ventricular rate in beats per minute measured at AF recurrence on 12-lead ECG or on the wearable PPG device."}
• {"endpoint_text":"- Blood pressure-lowering efficacy evaluated on blood pressure measurements from randomization to 1, 6, and 12 months as assessed by office blood pressure","definition_or_measurement_approach":"Office blood pressure measurements at baseline, 1, 6 and 12 months to assess blood pressure-lowering efficacy."}
• {"endpoint_text":"- Safety endpoints: occurrence of low blood pressure, changes in serum potassium and acute kidney injury from randomization and within 12 months","definition_or_measurement_approach":"Safety monitoring for hypotension, changes in serum potassium, and acute kidney injury occurring from randomization within 12 months."}

France

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

24-10-2024

Processing Time Days

15

Number Of Sites

14

Number Of Participants

580

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Caen Normandie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France