| - candidate number | 2256 |
| - NTR Number | NTR894 |
| - ISRCTN | ISRCTN52222985 |
| - Date ISRCTN created | 26-feb-2007 |
| - date ISRCTN requested | 21-feb-2007 |
| - Date Registered NTR | 20-sep-2006 |
| - Secondary IDs | 06/307 |
| - 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. |
| - ACRONYM | TIResiAS |
| - hypothesis | Hypertension can be prevented, or substantially delayed, by a temporary and early anti-hypertensive intervention with an ACE inhibitor in persons at high risk for future hypertension and hypertension related complications. |
| - Healt Condition(s) or Problem(s) studied | Prehypertension |
| - 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. |
| - mec approval received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-feb-2007 |
| - planned closingdate | 1-feb-2011 |
| - Target number of participants | 300 |
| - Interventions | 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 | Differences in ambulatory blood pressure between lisinopril and placebo 2 years after cessation of active treatment compared to baseline. |
| - Secondary outcome | Differences in left ventricular mass (index) and microalbuminuria between lisinopril and placebo 2 years after cessation of active treatment compared to baseline. |
| - Timepoints | |
| - Trial web site | http://www.tiresiasstudie.nl |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | B. Bogaard, van den |
| - CONTACT for SCIENTIFIC QUERIES | B. Bogaard, van den |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Vascular Medicine |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | |
| - Brief summary | Title Effects of Temporary Inhibition of the Renin-Angiotensin System on future blood pressure and hypertensive organ damage in young prehypertensive adults – TIResiAS. Objective To test the hypothesis whether treatment with an ACE inhibitor in young prehypertensive adults reduces blood pressure 2 years after cessation of active treatment and to determine whether this treatment can reduce left ventricular mass and microalbuminuria. Study design Multi-centre double blind randomized placebo controlled trial. Study population Otherwise healthy volunteers aged 18-40 years with an average blood pressure of 130-139 systolic and/or 85-89 mmHg diastolic on 2 separate office visits with less than 3 risk factors for cardiovascular disease according to current ESH guidelines. Excluded are subjects with previous antihypertensive treatment, any chronic disease requiring medication or specialist treatment, an elevated baseline serum glucose or elevated serum creatinine and women with a wish to become pregnant in the treatment period. Intervention Individuals are randomized to receive either lisinopril 10mg daily for three weeks followed by lisinopril 20mg daily or matched placebo for a period of one year. This is followed by two years of regular blood pressure monitoring. Primary endpoint Blood pressure 2 years after cessation of active treatment as evidenced by differences in 24 hour ambulatory blood pressure measurements. Secondary endpoints Differences in left ventricular mass and microalbuminuria 2 years after active treatment. |
| - Main changes (audit trail) | |
| - RECORD | 20-sep-2006 - 17-apr-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl