Central Hemodynamics

Value of Non-invasively Measured Arterial Stiffness and Central Hemodynamics for Guiding Antihypertensive Treatment in Selected Patient Populations

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).

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: Optimization of blood pressure according to guidelines

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Switzerland
  • Luzern, Switzerland, CH-6000
    • Recruiting
    • Luzerner Kantonsspital
    • Contact: Paul Erne, MD; Phone Number: ++41 41 205 5208; Email: paul.erne@luks.ch
    • Sub-Investigator: Renate Schoenenberger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly patients	Other: Optimization of blood pressure according to guidelines; 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.
Patients with diabetes mellitus	Other: Optimization of blood pressure according to guidelines; 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.
Patients with heart failure	Other: Optimization of blood pressure according to guidelines; 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.
Patients with resistant hypertension	Other: Optimization of blood pressure according to guidelines; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	Measurement with gait speed, hand grip test and physical activity questionnaire	3 months
Orthostatic hypotension and falls	Measurement with blood pressure recordings and structured questionnaire	3 months
Renal failure	Creatinine measurement	3 months

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Study Chair: Paul Erne, MD, Luzerner Kantonsspital; Principal Investigator: Andreas W Schoenenberger, MD, University Hospital of Bern

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 13024