Arrêt du Traitement Antihypertenseur Chez Les Patients Hypertendus Suivis en Médecine Générale / Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care: The STOP-Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 24
- 主要终点
- The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg)
研究概览
简要总结
The STOP-Trial is a prospective multicenter nonrandomized open study on grade I hypertension, performed by General practitioners.
The study will be conducted in parallel in the Clinical Investigation Center Plurithematic (CIC-P)1433 of Nancy (the study coordinating center) by the general practitioners investigators of the CIC-P.
The main purpose of the study is to determine the factors associated with the rate of patients remaining normotensive one year after stopping their antihypertensive monotherapy or low dose dual therapy:
- white coat hypertension
- primary diagnosis by home blood pressure measurements (HBPM) /ambulatory blood pressure measurements (ABPM) /clinical measure
- initial blood pressure level
- compliance
- therapeutic class versus others
- age
- gender
- weight variation
- modification of lifestyle
- concomitant treatments and associated substances
- ...
The primary endpoint will be the rate of normotensive patients at one year (i.e. HBPM values <135/85 mmHg).
详细描述
HBPM should be performed by the patients twice a day for 7 consecutive days before each visit (ESH protocol), using a device clinically tested (ESH/international protocol).
At baseline (visit 1), for the patients included, the antihypertensive treatment will be stopped in 3 consecutive days (half dose then interruption), over a maximum period of 12 months corresponding to the length of the participation and the monitoring of the patients.
Follow-up visits at day 30 (visit 2), day 90 (visit 3), day 180 (visit 4), day 270 (visit 5) and day 360 (visit 6). Will be performed at each visit:
- Calculation of the average of HBPM values by the investigator
- Measurements of office blood pressure (average of 3 consecutive measurements)
- SF 36 scale at baseline (visit 1) and day 360 (visit 6)
- During follow-up, the investigator will be free at any time to reintroduce an antihypertensive treatment if the average of HBPM values is greater than or equal to 135/85 mmHg on two consecutive visits, or greater than or equal to 155/95 mmHg regardless of the visit and regardless of the office blood pressure level.
At the end of study, the recovery of an antihypertensive treatment by the patients will be left to the discretion of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory patient above 18 years old.
- •Grade I hypertension at diagnosis.
- •Hypertension diagnosed and treated (whatever is its seniority and for at least 6 months) by antihypertensive drug.
- •Controlled hypertension (Clinical BP < 140/90 mmHg) or uncontrolled hypertension (Clinical BP > or equal to 140/90 mmHg) without modification of treatment for at least 6 months, by a monotherapy or a low dose dual therapy.
- •HBPM values < 135/85mmHg (in order to exclude masked hypertension).
- •Patient having signed the informed consent form.
- •Patient affiliated to a national insurance scheme.
排除标准
- •Personal cardiovascular history and/or necessity to take the antihypertensive treatment for another reason than hypertension (heart failure, migraine, peripheral arterial disease, coronary heart disease, stroke...).
- •Target organ damage (evidence of ventricular hypertrophy by ECG or cardiac echography and/or proteinuria and/or pathological micro-albuminuria presence showing a nephropathy, in the last year).
- •Poorly compliant patient, whose score of Girerd questionnaire is equal to or greater than
- •Existence of a progressive disease likely to impact on the life expectancy in a short term.
- •Existence of a documented atrial fibrillation (contraindication of HBPM).
- •Patient under a legal protection measure.
- •Chronic alcohol or drug abuse, regular intake of vasopressor effect substances (licorice,cocaine,...).
- •Current known pregnancy or project of pregnancy within one year.
研究组 & 干预措施
Hypertensive patients
Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence
干预措施: Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence (Drug)
结局指标
主要结局
The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg)
时间窗: At 12 months after antihypertensive treatment interruption
次要结局
- The rate of normotensive patients at 3 months (i.e HBPM <135/85 mmHg)(At 3 months after antihypertensive treatment interruption)
- The rate of normotensive patients at 9 months (i.e HBPM <135/85 mmHg)(At 9 months after antihypertensive treatment interruption)
- Evolution of the quality of life scale (part of SF36)(Change from baseline to 12 months after antihypertensive treatment interruption)
- The rate of normotensive patients at 6 months (i.e HBPM <135/85 mmHg)(At 6 months after antihypertensive treatment interruption)
研究者
Jean-Marc BOIVIN
Principal Investigator
Central Hospital, Nancy, France