Status:
COMPLETED
Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial)
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 3.
- 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.
Key Trial Info
Start Date :
March 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2020
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT02268071
Start Date
March 10 2015
End Date
October 21 2020
Last Update
June 22 2023
Active Locations (24)
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1
Cabinet de groupe Dr Birgé
Boulay, France, 57220
2
Cabinet de groupe Dr BAUDOIN
Bouzonville, France, 57320
3
Cabinet de groupe Dr Gries
Dettwiller, France, 67490
4
Cabinet du Dr Di Patrizio
Dombasle-sur-Meurthe, France, 54110