Resistant Arterial Hypertension Cohort Study | NCT01083017

Studies
Resistant Arterial Hypertension Cohort Study

NCT01083017

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Oct 30, 2018Actual

Enrollment

74Actual

Phase

Not provided

Conditions

Hypertension
Essential Hypertension
Resistant Hypertension

Interventions

chlorthalidone
motivational intervention for non-compliant individuals
standardized anti-hypertensive treatment

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
33CM30-124087	Other Grant/Funding Number	Swiss National Science Foundation
CER09-237	Other Identifier	IRB

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Mar 8, 2010

First Submission Date that Met QC Criteria

Mar 8, 2010

First Posted Date

Mar 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2018

Last Update Posted Date

Oct 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
chlorthalidone		Drug: chlorthalidone
motivational invervention	motivational interview(s) vs. repeated calls vs. no particular intervention	Behavioral: motivational intervention for non-compliant individuals
standardized anti-hypertensive treatment		Drug: standardized anti-hypertensive treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chlorthalidone	Drug	chlorthalidone 25mg/d vs. chlorthalidone 50mg/d	chlorthalidone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients addressed to a speciality consultation at Geneva University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antoinette PECHERE, MD	Geneva University Hospitals, Switzerland	Principal Investigator
Georg B EHRET, MD	Geneva University Hospitals, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospitals		Geneva			Switzerland
Lausanne University Hospital, CHUV

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002752	Chlorthalidone

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided