HypertensionRAHyCoNCT01083017
Resistant Arterial Hypertension Cohort Study
An observational study of Hypertension and Essential Hypertension, run by University Hospital, Geneva at 3 sites in Switzerland.
Trial summary
The purpose of this study is to investigate the epidemiology of resistant hypertension, evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the randomization of two doses of the diuretic used - chlorthalidone), study two interventions in the group of patients that is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Essential Hypertension, Resistant Hypertension
- What is being tested?
- chlorthalidone, motivational intervention for non-compliant individuals and standardized anti-hypertensive treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Apr 2011to May 2017
- Phase
- Observational
- 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
Study population: patients addressed to a speciality consultation at Geneva University Hospital
Who may be able to join
- informed consent
- resistant hypertension at the moment of inclusion
- 18 years or more, both sexes are included
- women at reproductive age: consenting to use oral contraception
Who cannot join
- patients mentally impaired or unable to give informed consent
- patients speaking only a foreign language other than French, German, or English
- patients living far away, making the study visits not practical
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Geneva University Hospitals
Geneva
Lausanne University Hospital, CHUV
Lausanne
Kantonsspital Luzern
Lucerne
About this study
Official title: Interventional Prospective Cohort Study, Multi-center With Nested Case-control Studies (Family-based and Non-family Based) on Individuals With Resistant Arterial Hypertension.
The purpose of this study is to investigate the epidemiology of resistant hypertension, evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the randomization of two doses of the diuretic used - chlorthalidone), study two interventions in the group of patients that is non-compliant, and study environmental and genetic variables of individuals with resistant hypertension in a family design.
- Conditions
- Hypertension, Essential Hypertension, Resistant Hypertension
- Being tested
- chlorthalidone, motivational intervention for non-compliant individuals, standardized anti-hypertensive treatment
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorthalidoneDrug
chlorthalidone 25mg/d vs. chlorthalidone 50mg/d
motivational intervention for non-compliant individualsBehavioural
motivational interview(s) vs. repeated calls vs. no particular intervention
standardized anti-hypertensive treatmentDrug
olmesartan, amlodipine, chlorthalidone, +- spironolactone
| Study group | Role | What they receive |
|---|---|---|
| chlorthalidone | Not described Receives: Drug: chlorthalidone | |
| motivational invervention | motivational interview(s) vs. repeated calls vs. no particular intervention Receives: Behavioral: motivational intervention for non-compliant individuals | |
| standardized anti-hypertensive treatment | Not described Receives: Drug: standardized anti-hypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure control
Measured: at 12 weeks after initiation of standard treatment
Secondary outcomes (1)
cardiovascular morbidity and mortality
additional secondary: BP control at yearly follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startApr 2011
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg EHRET, University Hospital, Geneva
- Investigators
- Antoinette PECHERE, MD, Principal investigator, Geneva University Hospitals, SwitzerlandGeorg B EHRET, MD, Principal investigator, Geneva University Hospitals, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083017
- Sponsor's protocol ID
- RAHyCOstudy
- Other IDs
- 33CM30-124087, CER09-237
- Acronym
- RAHyCo
- Status last verified
- Oct 2018
- First submitted
- 8 Mar 2010
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Prospective Cohort Study, Multi-center With Nested Case-control Studies (Family-based and Non-family Based) on Individuals With Resistant Arterial Hypertension.
- ClinicalTrials.gov ID
- NCT01083017
- Acronym / sponsor ID
- RAHyCo / RAHyCOstudy
- Conditions
- Hypertension, Essential Hypertension, Resistant Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 9 Mar 2010 (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 purpose of this study is to investigate the epidemiology of resistant hypertension, evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the randomization of two doses of the diuretic used - chlorthalidone), study two interventions in the group of patients that is non-compliant, and study environmental and genetic variables of individuals with resistant hypertension in a family design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chlorthalidone | – | Drug: chlorthalidone |
| motivational invervention | – | Behavioral: motivational intervention for non-compliant individualsmotivational interview(s) vs. repeated calls vs. no particular intervention |
| standardized anti-hypertensive treatment | – | Drug: standardized anti-hypertensive treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients addressed to a speciality consultation at Geneva University Hospital
Key inclusion criteria (4 listed)
- informed consent
- resistant hypertension at the moment of inclusion
- 18 years or more, both sexes are included
- women at reproductive age: consenting to use oral contraception
Key exclusion criteria (3 listed)
- patients mentally impaired or unable to give informed consent
- patients speaking only a foreign language other than French, German, or English
- patients living far away, making the study visits not practical
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 |
|---|---|---|
| chlorthalidonechlorthalidone 25mg/d vs. chlorthalidone 50mg/d | Drug | chlorthalidone |
| motivational intervention for non-compliant individualsmotivational interview(s) vs. repeated calls vs. no particular intervention | Behavioural | motivational invervention |
| standardized anti-hypertensive treatmentolmesartan, amlodipine, chlorthalidone, +- spironolactone | Drug | standardized anti-hypertensive treatment |
Primary outcome
blood pressure control
Time frame: at 12 weeks after initiation of standard treatment
1 secondary outcome
cardiovascular morbidity and mortality
Time frame: 5 years
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 30 Oct 2018.
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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.
Antoinette PECHERE, MD principal investigator
Geneva University Hospitals, Switzerland
Georg B EHRET, MD principal investigator
Geneva University Hospitals, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Essential Hypertension, run by University Hospital, Geneva at 3 sites in Switzerland.
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 4 inclusion and 3 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 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
blood pressure control (time frame: at 12 weeks after initiation of standard treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2018; AzTrials last refreshed its copy on 4 Nov 2026.