Clinical trial NCT02268071: Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial)
Official title: Arrêt du Traitement Antihypertenseur Chez Les Patients Hypertendus Suivis en Médecine Générale / Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care: The STOP-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Stopping antihypertensive treatment
Primary care
White coat hypertension
Masked Hypertension
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg)
timeFrame: At 12 months after antihypertensive treatment interruption
Secondary outcomes:
measure: The rate of normotensive patients at 3 months (i.e HBPM <135/85 mmHg)
timeFrame: At 3 months after antihypertensive treatment interruption
measure: The rate of normotensive patients at 6 months (i.e HBPM <135/85 mmHg)
timeFrame: At 6 months after antihypertensive treatment interruption
measure: The rate of normotensive patients at 9 months (i.e HBPM <135/85 mmHg)
timeFrame: At 9 months after antihypertensive treatment interruption
measure: Evolution of the quality of life scale (part of SF36)
timeFrame: Change from baseline to 12 months after antihypertensive treatment interruption
Other outcomes:
Locations:
city: Boulay
country: France
facility: Cabinet de groupe Dr Birgé
city: Bouzonville
country: France
facility: Cabinet de groupe Dr BAUDOIN
city: Dettwiller
country: France
facility: Cabinet de groupe Dr Gries
city: Dombasle Sur Meurthe
country: France
facility: Cabinet du Dr Di Patrizio
city: Dombasle Sur Meurthe
country: France
facility: Cabinet médical Dr Bouché
city: Dombasle Sur Meurthe
country: France
facility: Cabinet médical du Dr Chevillard
city: Gondrecourt Le Chateau
country: France
facility: Maison de santé Dr Millet-Malingrey
city: Grostenquin
country: France
facility: Maison de Santé Pluridisciplinaire de GROSTENQUIN
city: Hatten
country: France
facility: Cabinet de groupe Dr Rougerie
city: Jarville La Malgrange
country: France
facility: Cabinet du Dr Plane
city: Laxou
country: France
facility: Cabinet médical prof Boivin
city: Le Palais-sur-Vienne
country: France
facility: Cabinet du Dr LARQUE
city: Limoges
country: France
facility: Cabinet de groupe Dr Faure Christian
city: Limoges
country: France
facility: Cabinet Dr Bleynie
city: Neufchateau
country: France
facility: Cabinet du Dr Poyeton
city: Nexon
country: France
facility: Cabinet Dr Delage
city: Remilly
country: France
facility: Cabinet de groupe Dr Masson,
city: Revigny-sur-Ornain
country: France
facility: Cabinet de groupe en pôle de santé
city: Saint-Avold
country: France
facility: Cabinet du Dr Louyot-Keller
city: Saint-Max
country: France
facility: Cabinet médical du Dr Carrier
city: Strasbourg
country: France
facility: Maison de Santé du Neuhof
city: Talange
country: France
facility: cabinet de groupe Dr Steyer
city: Vandoeuvre Les Nancy
country: France
facility: Centre d'Investigation Clinique module plurithématique 1433 Inserm/CHRU de Nancy
city: Vicherey
country: France
facility: cabinet du Dr Gerard
Study officials:
affiliation: Centre d'Investigation Clinique Plurithématique/INSERM/CHU de Nancy
name: Jean-Marc BOIVIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: