Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229242
Status:
COMPLETED
Last Update Posted:
2009-12-14
First Post:
2005-09-13
Brief Title:
Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
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:
MAIN The benefits of treating high blood pressure successfully to normal levels on heart function are the same regardless of which particular combination of drugs are used SECONDARY Measurement of heart function using a comprehensive ultrasound imaging method Echocardiography and an objective test of functional ability are better predictors of changes in heart function with successful hypertension treatment than subjective signs of heart failure
Detailed Description:
Successful treatment of hypertension with single medications is very rare On average successful treatment requires more than 2 medications These medications work by different methods One of the ideas behind the use of combinations of medication for hypertension is that benefits are additive There are unresolved questions about whether the observed benefits are simply related to effective treatment of hypertension or whether some of the medications have special benefits independent of blood pressure lowering Each of these contentions has been justified by clinical trials However these trials have in common the flaw that hypertension is either not effectively controlled in all the treated subjects or the magnitude of blood pressure change after treatment is different in the groups compared The result of one of the largest blood pressure clinical trials called ALLHAT trial has recently fuelled this debate The ALLHAT trial which utilized only subjective symptoms and signs of heart failure called the FRAMINGHAM score to determine who has abnormal heart function implied that diuretics water pills were superior to the newer drugs in reducing the frequency of abnormal heart function This study shared the flaw of previous trials in not having equal blood pressure lowering in the groups Nevertheless it provided some evidence that argued against the notion that newer drugs were better than older drugs like diuretics Shortly after the publication of ALLHAT another trial called ANBP was published showing that the group of drugs that was least effective in ALLHAT was superior to diuretics in preventing important cardiovascular outcomes Hence it is not currently clear that there are differences between various drug combinations if effective and equal blood pressure lowering is achieved Another finding that may have confounded clinical trials that rely on subjective scores of heart dysfunction such as the ALLHAT is that a significant proportion of subjects with advanced heart disease are unaware of their heart problem and hence will probably not seek attention This raises the concern that the true frequency of abnormal heart function might not have been reported in those studies Using more modern tools such as Echocardiography a more complete assessment of heart dysfunction can be obtained In addition objective tests of heart function such as the 6-minute walk distance could yield a more reliable assessment of any worsening or improvement in heart function if performed serially in treated subjects In view of the above discussion only a study in which hypertension is effectively and similarly controlled could be used to answer the questions regarding different effects of various drug combinations Such is this study proposed
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