Resistant Arterial Hypertension Cohort Study (RAHyCo)

October 26, 2018 updated by: Georg EHRET, University Hospital, Geneva

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hospitals
      • Lausanne, Switzerland
        • Lausanne University Hospital, CHUV
      • Luzern, Switzerland
        • Kantonsspital Luzern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients addressed to a speciality consultation at Geneva University Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure control
Time Frame: at 12 weeks after initiation of standard treatment
at 12 weeks after initiation of standard treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular morbidity and mortality
Time Frame: 5 years
additional secondary: BP control at yearly follow-up
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Antoinette PECHERE, MD, Geneva University Hospitals, Switzerland
  • Principal Investigator: Georg B EHRET, MD, Geneva University Hospitals, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAHyCOstudy
  • 33CM30-124087 (Other Grant/Funding Number: Swiss National Science Foundation)
  • CER09-237 (Other Identifier: IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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