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HypertensionNCT02268071

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

A study testing Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence in people with Hypertension, run by Central Hospital, Nancy, France at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
403 participants
Where
24 sitesFrance
Study dates
10 Mar 2015to 21 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • Cabinet de groupe Dr Birgé

    Boulay, 57220

  • Cabinet de groupe Dr BAUDOIN

    Bouzonville, 57320

  • Cabinet de groupe Dr Gries

    Dettwiller, 67490

  • Cabinet du Dr Di Patrizio

    Dombasle-sur-Meurthe, 54110

  • Cabinet médical Dr Bouché

    Dombasle-sur-Meurthe, 54110

  • Cabinet médical du Dr Chevillard

    Dombasle-sur-Meurthe, 54110

  • Maison de santé Dr Millet-Malingrey

    Gondrecourt-le-Château, 55130

  • Maison de Santé Pluridisciplinaire de GROSTENQUIN

    Grostenquin, 57660

  • Cabinet de groupe Dr Rougerie

    Hatten, 67690

  • Cabinet du Dr Plane

    Jarville-la-Malgrange, 54140

  • Cabinet médical prof Boivin

    Laxou, 54520

  • Cabinet du Dr LARQUE

    Le Palais-sur-Vienne, 87410

  • Cabinet de groupe Dr Faure Christian

    Limoges, 87000

  • Cabinet Dr Bleynie

    Limoges, 87100

  • Cabinet du Dr Poyeton

    Neufchâteau, 88300

  • Cabinet Dr Delage

    Nexon, 87800

  • Cabinet de groupe Dr Masson,

    Rémilly, 57580

  • Cabinet de groupe en pôle de santé

    Revigny-sur-Ornain, 55800

  • Cabinet du Dr Louyot-Keller

    Saint-Avold, 57500

  • Cabinet médical du Dr Carrier

    Saint-Max, 54130

  • Maison de Santé du Neuhof

    Strasbourg

  • cabinet de groupe Dr Steyer

    Talange, 57525

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

    Vandœuvre-lès-Nancy, 54500

  • cabinet du Dr Gerard

    Vicherey, 88170

Other trials in France

About this study

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

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.

Read more

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).

Read the 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.

Conditions
Hypertension
Being tested
Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence
Keywords
Hypertension, Stopping antihypertensive treatment, Primary care, White coat hypertension, Masked Hypertension
Medical subject headings
Hypertension, White Coat Hypertension, Masked Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antihypertensive treatment will be stopped for 1 year unless hypertension recurrenceDrug

    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)

Study groups in NCT02268071
Study groupRoleWhat they receive
Hypertensive patientsExperimentalAntihypertensive treatment will be stopped for 1 year unless hypertension recurrence
Receives: Drug: Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At 12 months after antihypertensive treatment interruption

Secondary outcomes (4)

  1. The rate of normotensive patients at 3 months (i.e HBPM <135/85 mmHg)

    Measured: At 3 months after antihypertensive treatment interruption

  2. The rate of normotensive patients at 6 months (i.e HBPM <135/85 mmHg)

    Measured: At 6 months after antihypertensive treatment interruption

  3. The rate of normotensive patients at 9 months (i.e HBPM <135/85 mmHg)

    Measured: At 9 months after antihypertensive treatment interruption

  4. Evolution of the quality of life scale (part of SF36)

    Measured: Change from baseline to 12 months after antihypertensive treatment interruption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2014 (estimated)
  2. Study start10 Mar 2015
  3. Primary completion21 Oct 2020
  4. Study completion21 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02268071
Sponsor's protocol ID
2014-001773-14
Other IDs
2014
Status last verified
Jun 2023
First submitted
14 Oct 2014
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40838798

Questions about this trial

What is this clinical trial studying?

A study testing Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence in people with Hypertension, run by Central Hospital, Nancy, France at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg) (time frame: At 12 months after antihypertensive treatment interruption). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02268071, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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