Central Hemodynamics

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01837784
• Other study ID #: 13024
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2013
• Last updated: April 18, 2013
• Start date: April 2013

Study information

• Verified date: April 2013
• Source: Luzerner Kantonsspital
• Contact: Paul Erne, MD
• Phone: ++41 41 205 5208
• Email: paul.erne[@]luks.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness and central hemodynamics	Non-invasive measurement of arterial stiffness and central hemodynamics with the Tensiomed Arteriograph device	3 months	No
Primary	Cognitive function	Measurement with Mini Mental State Exam and Verbal Recall Test	3 months	No
Secondary	Physical function	Measurement with gait speed, hand grip test and physical activity questionnaire	3 months	No
Secondary	Orthostatic hypotension and falls	Measurement with blood pressure recordings and structured questionnaire	3 months	No
Secondary	Renal failure	Creatinine measurement	3 months	No