CompletedNot Applicable

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

France403 participantsStarted 2015-03-10

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 proje…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: At 12 months after antihypertensive treatment interruption

Trial details

NCT IDNCT02268071

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-21

View on ClinicalTrials.gov More Hypertension trials