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

• Status: Completed
• Trial end date: 2020-10-21
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Antihypertensive Agents; Tin Fluorides

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.