NCT01837784

Brief Summary

Guidelines recommend measuring end organ damage and in particular arterial stiffness in patients with hypertension. However, until now it was not possible to measure arterial stiffness with the use of simple methods. Recently, novel and innovative devices offering determination of arterial stiffness and central hemodynamics from simple and non-invasive arm cuff measurements have now become available. This study therefore evaluates the value of non-invasively measured arterial stiffness and central hemodynamics for guiding antihypertensive treatment in selected patient populations (i.e. elderly patients, patients with diabetes mellitus, patients with heart failure, and patients with resistant hypertension).

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

2.9 years

First QC Date

April 16, 2013

Last Update Submit

April 18, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Arterial stiffness and central hemodynamics

    Non-invasive measurement of arterial stiffness and central hemodynamics with the Tensiomed Arteriograph device

    3 months

  • Cognitive function

    Measurement with Mini Mental State Exam and Verbal Recall Test

    3 months

Secondary Outcomes (3)

  • Physical function

    3 months

  • Orthostatic hypotension and falls

    3 months

  • Renal failure

    3 months

Study Arms (4)

Elderly patients

Other: Optimization of blood pressure according to guidelines

Patients with diabetes mellitus

Other: Optimization of blood pressure according to guidelines

Patients with heart failure

Other: Optimization of blood pressure according to guidelines

Patients with resistant hypertension

Other: Optimization of blood pressure according to guidelines

Interventions

Optimization of blood pressure according to guidelinesOTHER

There is no specific recommendation for the intervention. The goal of the intervention is an optimization of blood pressure control. The intervention is at the discretion of the physician, but should adhere to guidelines. The intervention may therefore embrace measures such as drug prescriptions or lifestyle interventions.

Elderly patientsPatients with diabetes mellitusPatients with heart failurePatients with resistant hypertension

Eligibility Criteria

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

Patients referred for optimization of antihypertensive treatment to Luzerner Kantonsspital, Switzerland.

You may qualify if:

  • Patients \>70 years (elderly cohort)
  • Patients with diabetes mellitus (diabetes cohort)
  • Patients with heart failure (heart failure cohort)
  • Patients with resistant hypertension (resistant hypertension cohort)

You may not qualify if:

  • Patient refuses study participation
  • Severe renal failure
  • Reduced life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, CH-6000, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Paul Erne, MD

    Luzerner Kantonsspital

    STUDY CHAIR

  • Paul Erne, MD

    Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

  • Andreas W Schoenenberger, MD

    University hospital of Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Erne, MD

CONTACT

++41 41 205 5208paul.erne@luks.ch

Andreas W Schoenenberger, MD

CONTACT

++41 79 243 6985Andreas.Schoenenberger@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Cardiology

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 23, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2016

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

CH(1)