Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial)

NCT02268071 | Completed

• 1 other identifier: 2014-001773-14
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 24

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 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).

Conditions

Hypertension

Keywords

Hypertension; Stopping antihypertensive treatment; Primary care; White coat hypertension; Masked Hypertension

Outcome Measures

Primary Outcomes (1)

• The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg)

  At 12 months after antihypertensive treatment interruption

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

Hypertensive patients

EXPERIMENTAL

Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence

Drug: Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence

Interventions

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)

Hypertensive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (24)

Cabinet de groupe Dr Birgé

Boulay, 57220, France

Location

Cabinet de groupe Dr BAUDOIN

Bouzonville, 57320, France

Location

Cabinet de groupe Dr Gries

Dettwiller, 67490, France

Location

Cabinet du Dr Di Patrizio

Dombasle-sur-Meurthe, 54110, France

Location

Cabinet médical Dr Bouché

Dombasle-sur-Meurthe, 54110, France

Location

Cabinet médical du Dr Chevillard

Dombasle-sur-Meurthe, 54110, France

Location

Maison de santé Dr Millet-Malingrey

Gondrecourt-le-Château, 55130, France

Location

Maison de Santé Pluridisciplinaire de GROSTENQUIN

Grostenquin, 57660, France

Location

Cabinet de groupe Dr Rougerie

Hatten, 67690, France

Location

Cabinet du Dr Plane

Jarville-la-Malgrange, 54140, France

Location

Cabinet médical prof Boivin

Laxou, 54520, France

Location

Cabinet du Dr LARQUE

Le Palais-sur-Vienne, 87410, France

Location

Cabinet de groupe Dr Faure Christian

Limoges, 87000, France

Location

Cabinet Dr Bleynie

Limoges, 87100, France

Location

Cabinet du Dr Poyeton

Neufchâteau, 88300, France

Location

Cabinet Dr Delage

Nexon, 87800, France

Location

Cabinet de groupe en pôle de santé

Revigny-sur-Ornain, 55800, France

Location

Cabinet de groupe Dr Masson,

Rémilly, 57580, France

Location

Cabinet du Dr Louyot-Keller

Saint-Avold, 57500, France

Location

Cabinet médical du Dr Carrier

Saint-Max, 54130, France

Location

Maison de Santé du Neuhof

Strasbourg, France

Location

cabinet de groupe Dr Steyer

Talange, 57525, France

Location

Centre d'Investigation Clinique module plurithématique 1433 Inserm/CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

cabinet du Dr Gerard

Vicherey, 88170, France

Location

Related Publications (1)

• 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.

  PMID: 40838798 DERIVED

MeSH Terms

Conditions

Hypertension; White Coat Hypertension; Masked Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Marc BOIVIN, MD, PhD

  Centre d'Investigation Clinique Plurithématique/INSERM/CHU de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 20, 2014
• Study Start: March 10, 2015
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (24)