RAHyCo: Resistant Arterial Hypertension Cohort Study

• Sponsor: University Hospital, Geneva (Other)
• Overall Status: Completed
• CT.gov ID: NCT01083017
• Collaborator: (none)
• Enrollment: 74
• Locations: 3
• Duration (Months): 73
• Patients Per Site: 24.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 74 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: Apr 1, 2011
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. blood pressure control [at 12 weeks after initiation of standard treatment]

Secondary Outcome Measures

1. cardiovascular morbidity and mortality [5 years]

   additional secondary: BP control at yearly follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospitals	Geneva		Switzerland
2	Lausanne University Hospital, CHUV	Lausanne		Switzerland
3	Kantonsspital Luzern	Luzern		Switzerland

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Georg EHRET, intern, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT01083017
• Other Study ID Numbers: RAHyCOstudy; 33CM30-124087; CER09-237
• First Posted: Mar 9, 2010
• Last Update Posted: Oct 30, 2018
• Last Verified: Oct 1, 2018

• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Chlorthalidone; Antihypertensive Agents

Study Results

No Results Posted as of Oct 30, 2018