Condition category
Circulatory System
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
27/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.tiresiastrial.nl

Contact information

Type

Scientific

Primary contact

Dr B van den Bogaard

ORCID ID

Contact details

Academic Medical Centre
Department of Vascular Medicine
Meibergdreef 9 (room F4-255)
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 5981
B.vandenBogaard@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/307

Study information

Scientific title

Acronym

TIResiAS

Study hypothesis

Hypertension can be prevented, or substantially delayed, by a temporary and early anti-hypertensive intervention with an Angiotensin Converting Enzyme (ACE) inhibitor in persons at high risk for future hypertension and hypertension related complications.

Ethics approval

Not provided at time of registration

Study design

Randomised, placebo controlled, parallel group, double blinded, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Prehypertension

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Lisinopril

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/02/2007

Overall trial end date

01/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Otherwise healthy persons aged 18 to 40 years with three 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 two separate visits with an interval of one week and measured by a validated automatic blood pressure device.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

1. Previous antihypertensive treatment
2. Any chronic use of prescribed oral medication except oral contraceptives
3. An elevated baseline serum glucose (more than 7.0 mmol/L) or elevated serum creatinine(more than 95 ummol/L for women and more than 110 ummol/L for men)
4. Women with a wish to become pregnant in the treatment period

Recruitment start date

01/02/2007

Recruitment end date

01/02/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Vascular Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/#http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes