Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150631
Status:
UNKNOWN
Last Update Posted:
2014-11-26
First Post:
2005-09-06
Brief Title:
Danish Hypertension Prevention Project - DHYPP
Sponsor:
Karin Skov
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Danish Hypertension Prevention Project
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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treatment with either the AT1-antagonist candesartan cilexetil 16 mg daily or placebo for one year Then treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension The primary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 05 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
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 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None