2024-518146-25-00招募中3 期
SPironolactONe for the maintenance of Sinus Rhythm in hypertensive patients with atrial fibrillation and preserved left ventricular ejection fraction: a Prospective Randomized Open Blinded End-point (PROBE) multicenter study (SPONSoR study).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 580
- 试验地点
- 13
- 主要终点
- 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)
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •□ 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)
- •□ Recipients of the social security regime
- •□ 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 12 months
- •□ Sinus rhythm at enrolment
- •□ Patients with a smartphone (Android or iPhone)
- •□ Patient signed consent
- •□ Willing to comply with scheduled visits, as outlined in the protocol
- •□ French speaking
排除标准
- •□ Contraindications 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
- •□ Acute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis)
- •□ Left atrium diameter > 60 mm obtained within 6 months prior to V0
- •□ Patients 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
- •□ 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
- •□ 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
结局指标
主要结局
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)
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)
次要结局
- The recurrence of symptomatic documented AF episodes from randomization and within 12 months
- The delay (days) of recurrence of the first documented AF episode (symptomatic or not) during the follow-up
- 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
- Composite of major cardiovascular events and death (death from any cause, stroke, heart failure, myocardial infarction) occurring from randomization and within 12 months
- Occurrence of cerebral/systemic thrombo-embolic and bleeding events
- 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)
- Blood pressure-lowering efficacy evaluated on blood pressure measurements from randomization to 1, 6, and 12 months as assessed by office blood pressure
- Safety endpoints: occurrence of low blood pressure, changes in serum potassium and acute kidney injury from randomization and within 12 months
研究者
Coordinating investigator
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (13)
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