Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial)
NCT ID: NCT02268071
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
403 participants
INTERVENTIONAL
2015-03-10
2020-10-21
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypertensive patients
Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence
Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence
For patients with average of HBPM values \<135/85mmHg at baseline, the antihypertensive treatment will be stopped for 1 year (half dose for 3 days then interruption)
Interventions
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Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence
For patients with average of HBPM values \<135/85mmHg at baseline, the antihypertensive treatment will be stopped for 1 year (half dose for 3 days then interruption)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Jean-Marc BOIVIN
Principal Investigator
Principal Investigators
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Jean-Marc BOIVIN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation Clinique Plurithématique/INSERM/CHU de Nancy
Locations
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Cabinet de groupe Dr Birgé
Boulay, , France
Cabinet de groupe Dr BAUDOIN
Bouzonville, , France
Cabinet de groupe Dr Gries
Dettwiller, , France
Cabinet du Dr Di Patrizio
Dombasle-sur-Meurthe, , France
Cabinet médical Dr Bouché
Dombasle-sur-Meurthe, , France
Cabinet médical du Dr Chevillard
Dombasle-sur-Meurthe, , France
Maison de santé Dr Millet-Malingrey
Gondrecourt-le-Château, , France
Maison de Santé Pluridisciplinaire de GROSTENQUIN
Grostenquin, , France
Cabinet de groupe Dr Rougerie
Hatten, , France
Cabinet du Dr Plane
Jarville-la-Malgrange, , France
Cabinet médical prof Boivin
Laxou, , France
Cabinet du Dr LARQUE
Le Palais-sur-Vienne, , France
Cabinet de groupe Dr Faure Christian
Limoges, , France
Cabinet Dr Bleynie
Limoges, , France
Cabinet du Dr Poyeton
Neufchâteau, , France
Cabinet Dr Delage
Nexon, , France
Cabinet de groupe en pôle de santé
Revigny-sur-Ornain, , France
Cabinet de groupe Dr Masson,
Rémilly, , France
Cabinet du Dr Louyot-Keller
Saint-Avold, , France
Cabinet médical du Dr Carrier
Saint-Max, , France
Maison de Santé du Neuhof
Strasbourg, , France
cabinet de groupe Dr Steyer
Talange, , France
Centre d'Investigation Clinique module plurithématique 1433 Inserm/CHRU de Nancy
Vandœuvre-lès-Nancy, , France
cabinet du Dr Gerard
Vicherey, , France
Countries
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References
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Boivin JM, Ferreira JP, Lopez-Sublet M, Duarte K, Zannad F, Rossignol P, Girerd N. Stopping antihypertensive Treatment amOng hypertensive patients in Primary care: The STOP-Trial. Eur J Prev Cardiol. 2025 Aug 21:zwaf511. doi: 10.1093/eurjpc/zwaf511. Online ahead of print.
Other Identifiers
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2014-001773-14
Identifier Type: -
Identifier Source: org_study_id
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