Danish Hypertension Prevention Project - DHYPP

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Aarhus
AstraZeneca
Information provided by:
Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00150631
First received: September 6, 2005
Last updated: November 29, 2005
Last verified: September 2005
  Purpose

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 Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension.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 Intervention Phase
Hypertension
Drug: Candesartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Danish Hypertension Prevention Project

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: November 2000
Estimated Study Completion Date: December 2015
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

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150631

Locations
Denmark
Karin Skov
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital Skejby
University of Aarhus
AstraZeneca
Investigators
Study Chair: Hans E. Hansen, Dr.Med. Department of Nephrology, Skejby Hospital
Study Chair: Michael J. Mulvany, Prof. Dept. of Pharmacology, Aarhus University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150631     History of Changes
Other Study ID Numbers: 20000114
Study First Received: September 6, 2005
Last Updated: November 29, 2005
Health Authority: Denmark: National Board of Health

Keywords provided by Aarhus University Hospital Skejby:
Hypertension
Prevention
Offspring
Prevent or delay development of hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014