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Resistant Arterial Hypertension Cohort Study (RAHyCo)

This study is currently recruiting participants.
Verified August 2011 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Georg EHRET, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01083017
First received: March 8, 2010
Last updated: August 26, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention 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
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • blood pressure control [ Time Frame: at 12 weeks after initiation of standard treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiovascular morbidity and mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    additional secondary: BP control at yearly follow-up


Biospecimen Retention:   Samples With DNA

serum, DNA, urine


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Georg EHRET, intern, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01083017     History of Changes
Other Study ID Numbers: RAHyCOstudy, 33CM30‐124087, CER09-237
Study First Received: March 8, 2010
Last Updated: August 26, 2011
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on May 16, 2013