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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01083017
Other study ID # RAHyCOstudy
Secondary ID 33CM30-124087CER
Status Completed
Phase
First received
Last updated
Start date April 2011
Est. completion date May 2017

Study information

Verified date October 2018
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 non-compliant, and study environmental and genetic variables of individuals with resistant hypertension in a family design.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

Drug:
chlorthalidone
chlorthalidone 25mg/d vs. chlorthalidone 50mg/d
Behavioral:
motivational intervention for non-compliant individuals
motivational interview(s) vs. repeated calls vs. no particular intervention
Drug:
standardized anti-hypertensive treatment
olmesartan, amlodipine, chlorthalidone, +- spironolactone

Locations

Country Name City State
Switzerland Geneva University Hospitals Geneva
Switzerland Lausanne University Hospital, CHUV Lausanne
Switzerland Kantonsspital Luzern Luzern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood pressure control at 12 weeks after initiation of standard treatment
Secondary cardiovascular morbidity and mortality additional secondary: BP control at yearly follow-up 5 years
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