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Resistant Arterial Hypertension Cohort Study (RAHyCo)

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ClinicalTrials.gov Identifier: NCT01083017
Recruitment Status : Recruiting
First Posted : March 9, 2010
Last Update Posted : August 30, 2011
Sponsor:
Information provided by (Responsible Party):
Georg EHRET, University Hospital, Geneva

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Essential Hypertension Resistant Hypertension Drug: chlorthalidone Behavioral: motivational intervention for non-compliant individuals Drug: standardized anti-hypertensive treatment Phase 4

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : April 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. blood pressure control [ Time Frame: at 12 weeks after initiation of standard treatment ]

Secondary Outcome Measures :
  1. cardiovascular morbidity and mortality [ Time Frame: 5 years ]
    additional secondary: BP control at yearly follow-up


Biospecimen Retention:   Samples With DNA
serum, DNA, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients addressed to a speciality consultation at Geneva University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083017


Contacts
Contact: Georg B EHRET, MD 011-41-22-7920322 georg@rhone.ch

Locations
Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland
Contact: Georg B EHRET, MD    011-41-22-3723311    georg@rhone.ch   
Contact: Antoinette PECHERE, MD    011-41-22-3723311      
Lausanne University Hospital, CHUV Not yet recruiting
Lausanne, Switzerland
Contact: Gregoire Wuerzner, MD         
Kantonsspital Luzern Recruiting
Luzern, Switzerland
Contact: Paul Erne, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Antoinette PECHERE, MD Geneva University Hospitals, Switzerland
Principal Investigator: Georg B EHRET, MD Geneva University Hospitals, Switzerland

Responsible Party: Georg EHRET, intern, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01083017     History of Changes
Other Study ID Numbers: RAHyCOstudy
33CM30‐124087 ( Other Grant/Funding Number: Swiss National Science Foundation )
CER09-237 ( Other Identifier: IRB )
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Antihypertensive Agents
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chlorthalidone
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action