Effects of Temporary Inhibition of the Renin-Angiotensin System on future blood pressure and hypertensive organ damage in young prehypertensive adults - TIResiAS.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR894
• Date of registration: 20/09/2006
• Primary sponsor: Academic Medical Center (AMC), Department of Vascular Medicine
• Public title: Effects of Temporary Inhibition of the Renin-Angiotensin System on future blood pressure and hypertensive organ damage in young prehypertensive adults - TIResiAS.
• Scientific title: Effects of Temporary Inhibition of the Renin-Angiotensin System on future blood pressure and hypertensive organ damage in young prehypertensive adults - TIResiAS. - TIResiAS
• Date of first enrolment: 1/2/2007
• Target sample size: 300
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=894
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: B. Bogaard, van den

• Name: B. Bogaard, van den

Key inclusion & exclusion criteria

Inclusion criteria: Otherwise healthy persons aged 18-40 years with 3 cardiovascular risk factors or less and an average blood pressure of 130-139 systolic/below 90 mmHg diastolic and/or below 130 systolic/ 85-89 mmHg diastolic on 2 separate visits with an interval of 1 week and measured by a validated automatic blood pressure device.
Exclusion criteria: 1. Previous antihypertensive treatment;
2. Any chronic use of prescribed oral medication except oral contraceptives;
3. An elevated baseline serum glucose (>7.0 mmol/L) or elevated serum creatinine(> 95 ummol/L for women and >110 ummol/L for men);
4. Women with a wish to become pregnant in the treatment period.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Prehypertension

Intervention(s)

Individuals are randomized to receive either lisinopril 10mg daily for three weeks followed by a forced titration to lisinopril 20mg daily or matched placebo for a period of one year. This is followed by two years of close observation without active treatment.

Primary Outcome(s)

Differences in ambulatory blood pressure between lisinopril and placebo 2 years after cessation of active treatment compared to baseline.

Secondary Outcome(s)

Differences in left ventricular mass (index) and microalbuminuria between lisinopril and placebo 2 years after cessation of active treatment compared to baseline.

Secondary ID(s)

06/307

ISRCTN52222985

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development