NCT01083017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

6.1 years

First QC Date

March 8, 2010

Last Update Submit

October 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • blood pressure control

    at 12 weeks after initiation of standard treatment

Secondary Outcomes (1)

  • cardiovascular morbidity and mortality

    5 years

Study Arms (3)

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

chlorthalidone 25mg/d vs. chlorthalidone 50mg/d

chlorthalidone

motivational interview(s) vs. repeated calls vs. no particular intervention

motivational invervention

olmesartan, amlodipine, chlorthalidone, +- spironolactone

standardized anti-hypertensive treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients addressed to a speciality consultation at Geneva University Hospital

You may qualify if:

  • informed consent
  • years or more, both sexes are included
  • women at reproductive age: consenting to use oral contraception

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Geneva University Hospitals

Geneva, Switzerland

Location

Lausanne University Hospital, CHUV

Lausanne, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, DNA, urine

MeSH Terms

Conditions

HypertensionEssential Hypertension

Interventions

Chlorthalidone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Antoinette PECHERE, MD

    Geneva University Hospitals, Switzerland

    PRINCIPAL INVESTIGATOR
  • Georg B EHRET, MD

    Geneva University Hospitals, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
intern

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 9, 2010

Study Start

April 1, 2011

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations