Danish Hypertension Prevention Project - DHYPP

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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 Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension.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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Candesartan	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Official Title:	Danish Hypertension Prevention Project
Study Start Date :	November 2000
Actual Primary Completion Date :	January 2004
Estimated Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: active (candesartan); 12 mo treatment with candesartan	Drug: Candesartan; placebo controlled double blind; Other Name: atacand
Placebo Comparator: placebo; 12 mo placebo treatment

Outcome Measures

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Primary Outcome Measures :

1. The primary outcome is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension. [ Time Frame: 10 years ]
2. 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. [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 36 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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 -

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Denmark
Karin Skov
Aarhus, Denmark, 8000

Sponsors and Collaborators

Karin Skov

University of Aarhus

AstraZeneca

Investigators

Study Chair:	michael mulvany, prof	Dept. of Pharmacology, Aarhus University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Karin Skov, consultant, ph.d., Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:	NCT00150631 History of Changes
Other Study ID Numbers:	20000114
First Posted:	September 8, 2005
Last Update Posted:	November 26, 2014
Last Verified:	November 2014

Keywords provided by Karin Skov, Aarhus University Hospital Skejby:

Hypertension; Prevention; Offspring; Prevent or delay development of hypertension

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Candesartan; Candesartan cilexetil	Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action