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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:
The primary endpoint will be the rate of normotensive patients at one year (i.e. HBPM values <135/85 mmHg).
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:
At the end of study, the recovery of an antihypertensive treatment by the patients will be left to the discretion of the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertensive patients | Experimental | Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg) | At 12 months after antihypertensive treatment interruption |
| Measure | Description | Time Frame |
|---|---|---|
| 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 6 months (i.e HBPM <135/85 mmHg) | At 6 months after antihypertensive treatment interruption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc BOIVIN, MD, PhD | Centre d'Investigation Clinique Plurithématique/INSERM/CHU de Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet de groupe Dr Birgé | Boulay | 57220 | France | |||
| Cabinet de groupe Dr BAUDOIN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40838798 | Derived | 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. 2026 May 15;33(7):1274-1286. doi: 10.1093/eurjpc/zwaf511. |
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| 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 |
| Bouzonville |
| 57320 |
| France |
| Cabinet de groupe Dr Gries | Dettwiller | 67490 | France |
| Cabinet du Dr Di Patrizio | Dombasle-sur-Meurthe | 54110 | France |
| Cabinet médical Dr Bouché | Dombasle-sur-Meurthe | 54110 | France |
| Cabinet médical du Dr Chevillard | Dombasle-sur-Meurthe | 54110 | France |
| Maison de santé Dr Millet-Malingrey | Gondrecourt-le-Château | 55130 | France |
| Maison de Santé Pluridisciplinaire de GROSTENQUIN | Grostenquin | 57660 | France |
| Cabinet de groupe Dr Rougerie | Hatten | 67690 | France |
| Cabinet du Dr Plane | Jarville-la-Malgrange | 54140 | France |
| Cabinet médical prof Boivin | Laxou | 54520 | France |
| Cabinet du Dr LARQUE | Le Palais-sur-Vienne | 87410 | France |
| Cabinet de groupe Dr Faure Christian | Limoges | 87000 | France |
| Cabinet Dr Bleynie | Limoges | 87100 | France |
| Cabinet du Dr Poyeton | Neufchâteau | 88300 | France |
| Cabinet Dr Delage | Nexon | 87800 | France |
| Cabinet de groupe en pôle de santé | Revigny-sur-Ornain | 55800 | France |
| Cabinet de groupe Dr Masson, | Rémilly | 57580 | France |
| Cabinet du Dr Louyot-Keller | Saint-Avold | 57500 | France |
| Cabinet médical du Dr Carrier | Saint-Max | 54130 | France |
| Maison de Santé du Neuhof | Strasbourg | France |
| cabinet de groupe Dr Steyer | Talange | 57525 | France |
| Centre d'Investigation Clinique module plurithématique 1433 Inserm/CHRU de Nancy | Vandœuvre-lès-Nancy | 54500 | France |
| cabinet du Dr Gerard | Vicherey | 88170 | France |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D059466 | White Coat Hypertension |
| D059468 | Masked Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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