Danish Hypertension Prevention Project - DHYPP
Information source: Aarhus University Hospital Skejby
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Candesartan (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Karin Skov Official(s) and/or principal investigator(s): michael mulvany, prof, Study Chair, Affiliation: Dept. of Pharmacology, Aarhus University
Summary
The present study examine healthy, normotensive subjects 18 to 36 years of age whose both
parents have essential hypertension. The subjects receive treatment with either the
AT1-antagonist candesartan cilexetil, 16 mg daily or placebo for one year. Then, treatment
is withdrawn and the subjects is followed for 10 years to determine if the treatment has
been able to either prevent or delay the development of hypertension. The primary objective
is to determine whether pharmacological treatment with an angiotensin receptor blocker is
able to restrain or delay the progression to hypertension. Secondary objectives are to
investigate whether any long-term effect on blood pressure is related to the effect of
treatment on renal haemodynamic function, or on the left ventricle mass.
Clinical Details
Official title: Danish Hypertension Prevention Project
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: The primary outcome is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension.Secondary outcomes are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
Detailed description:
Essential hypertension, a major health problem worldwide, is a disease generally considered
to require life-long treatment. However, evidence suggests that hypertension is caused by
specific phenotypic changes caused by a combination of genetic and environmental factors.
Thus, in principle, hypertension could be prevented by prevention of these phenotypic
changes. Animal data indicate that early treatment that blocks the renin-angiotensin system
have long-term effects after treatment withdrawal. The present human study is testing
whether early treatment (with the AT1- antagonist) is able to have a persistent effect after
stopping treatment.
This is a monocenter, double-blind, randomized, placebo-controlled study in healthy,
normotensive (consultation diastolic blood pressure over 2 visits < 85 mmHg) subjects 18 to
36 years of age whose both parents have essential hypertension. The primary objective is to
determine whether pharmacological treatment with an angiotensin receptor blocker is able to
restrain or delay the progression to hypertension. Secondary objectives are to investigate
whether any long-term effect on blood pressure is related to the effect of treatment on
renal haemodynamic function, or on the left ventricle mass.
Subjects are recruited by use of hospital registers to identify persons who have received
the indication essential hypertension, and are of an age that they may have children of the
appropriate age. These persons are then mailed asking if they do have children with a
partner who is also hypertensive, and asking permission to contact the children. The
diagnosis of hypertension of the parents is checked following evaluation by the physicians
who are treating them.
One hundred subjects were randomly assigned to one of two treatment groups: placebo; or
candesartan cilexetil, 16 mg, once daily. Before inclusion and after 12 months of treatment
glomerular filtration rate, renal vascular resistance, echocardiography and 24-hour blood
pressure monitoring were performed. Subjects were evaluated at 0. 5, 1, 2, 4, 6 and 10 months
to ensure compliance and to control blood pressure. After 12-months of treatment, 24-hour
blood pressure monitoring were performed in a scheduled manner over a 10-year period. The
primary effect parameter is 24-hour blood pressure measured 10 years after withdrawal of
treatment. Interim analyses will be made at 1, 2 and 5 years by an independent data
committee. Secondary effect parameters will be numbers on antihypertensive treatment at 2,
5 and 10 years after withdrawal, as well as the effect of treatment on renal vascular
resistance and left ventricular mass.
A substudy is comparing renal haemodynamics and genetic profil of the subjects with persons
having normotensive parents.
Eligibility
Minimum age: 18 Years.
Maximum age: 36 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Both parents have essential hypertension
2. Age 18 - 36 years
3. Caucasians
4. Diastolic blood pressure less than 85 mmHg at inclusion time
5. Female participants using orale anticonceptives ot intrauterine devices
Exclusion Criteria:
1. Clinical or biochemically signs of disease in kidney, liver, or endocrine organs
2. Diastolic blood pressure above 85 mmHg at inclusion time
3. Pregnancy or pregnancy wish
4. Daily medication, except for orale anticoncetives -
Locations and Contacts
Karin Skov, Aarhus 8000, Denmark
Additional Information
Starting date: November 2000
Last updated: November 25, 2014
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