search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number2256
- NTR NumberNTR894
- ISRCTNISRCTN52222985
- Date ISRCTN created26-feb-2007
- date ISRCTN requested21-feb-2007
- Date Registered NTR20-sep-2006
- Secondary IDs06/307 
- Public TitleEffects of Temporary Inhibition of the Renin-Angiotensin System on future blood pressure and hypertensive organ damage in young prehypertensive adults - TIResiAS.
- Scientific TitleEffects of Temporary Inhibition of the Renin-Angiotensin System on future blood pressure and hypertensive organ damage in young prehypertensive adults - TIResiAS.
- ACRONYMTIResiAS
- hypothesisHypertension 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) studiedPrehypertension
- Inclusion criteriaOtherwise 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 criteria1. 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2007
- planned closingdate1-feb-2011
- Target number of participants300
- InterventionsIndividuals 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 outcomeDifferences in ambulatory blood pressure between lisinopril and placebo 2 years after cessation of active treatment compared to baseline.
- Secondary outcomeDifferences in left ventricular mass (index) and microalbuminuria between lisinopril and placebo 2 years after cessation of active treatment compared to baseline.
- Timepoints
- Trial web sitehttp://www.tiresiasstudie.nl
- statusplanned
- 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 summaryTitle 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)
- RECORD20-sep-2006 - 17-apr-2007


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl