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

ISRCTN	ISRCTN52222985
DOI	https://doi.org/10.1186/ISRCTN52222985
Secondary identifying numbers	06/307, NL880 (NTR894)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 26/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr B van den Bogaard
Scientific

Academic Medical Centre
Department of Vascular Medicine
Meibergdreef 9 (room F4-255)
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 5981
Email	B.vandenBogaard@amc.uva.nl

Study information

Study design	Randomised, placebo controlled, parallel group, double blinded, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Effects of Temporary Inhibition of the Renin-Angiotensin System on future blood pressure and hypertensive organ damage in young prehypertensive adults
Study acronym	TIResiAS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lisinopril
Primary outcome measure	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 study start date	01/02/2007
Completion date	01/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	300
Key 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.
Key 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
Date of first enrolment	01/02/2007
Date of final enrolment	01/02/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/08/2007	26/03/2021	Yes	No

Editorial Notes

26/03/2021: Publication reference added.