Danish Hypertension Prevention Project - DHYPP

NCT ID: NCT00150631

Last Updated: 2014-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2014-12-31

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 Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension.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

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

active (candesartan)

12 mo treatment with candesartan

Group Type: PLACEBO_COMPARATOR

Candesartan

Intervention Type: DRUG

placebo controlled double blind

placebo

12 mo placebo treatment

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Candesartan

placebo controlled double blind

Intervention Type: DRUG

Other Intervention Names

atacand

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Karin Skov

OTHER

Sponsor Role: lead

Responsible Party

Karin Skov

consultant, ph.d.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

michael mulvany, prof

Role: STUDY_CHAIR

Dept. of Pharmacology, Aarhus University

Locations

Karin Skov

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

20000114

Identifier Type: -

Identifier Source: org_study_id