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.
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
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 group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Experimental | Antihypertensive 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.
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)
The rate of normotensive patients at 3 months (i.e HBPM <135/85 mmHg)
Measured: At 3 months after antihypertensive treatment interruption
The rate of normotensive patients at 6 months (i.e HBPM <135/85 mmHg)
Measured: At 6 months after antihypertensive treatment interruption
The rate of normotensive patients at 9 months (i.e HBPM <135/85 mmHg)
Measured: At 9 months after antihypertensive treatment interruption
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.
- First posted20 Oct 2014 (estimated)
- Study start10 Mar 2015
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Marc BOIVIN, Central Hospital, Nancy, France
- Investigators
- Jean-Marc BOIVIN, MD, PhD, Principal investigator, Centre d'Investigation Clinique Plurithématique/INSERM/CHU de Nancy
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02268071
- Acronym / sponsor ID
- 2014-001773-14
- Conditions
- Hypertension
- Keywords
- Hypertension, Stopping antihypertensive treatment, Primary care, White coat hypertension, Masked Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Mar 2015
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | Experimental | Drug: Antihypertensive treatment will be stopped for 1 year unless hypertension recurrenceAntihypertensive treatment will be stopped for 1 year unless hypertension recurrence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihypertensive treatment will be stopped for 1 year unless hypertension recurrenceFor 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) | Drug | Hypertensive patients |
Primary outcome
The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg)
Time frame: At 12 months after antihypertensive treatment interruption
4 secondary outcomes
The rate of normotensive patients at 3 months (i.e HBPM <135/85 mmHg)
Time frame: At 3 months after antihypertensive treatment interruption
The rate of normotensive patients at 6 months (i.e HBPM <135/85 mmHg)
Time frame: At 6 months after antihypertensive treatment interruption
The rate of normotensive patients at 9 months (i.e HBPM <135/85 mmHg)
Time frame: At 9 months after antihypertensive treatment interruption
Evolution of the quality of life scale (part of SF36)
Time frame: Change from baseline to 12 months after antihypertensive treatment interruption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 40838798Boivin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc BOIVIN, MD, PhD principal investigator
Centre d'Investigation Clinique Plurithématique/INSERM/CHU de Nancy
24 sites in 1 country: see every site and its status.
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.