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Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00229242
First Posted: September 29, 2005
Last Update Posted: December 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Queen's University
  Purpose
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.

Condition Intervention
Hypertension Drug: Diuretic-Based or Non-Diuretic Based Hypertension Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Measurement of systolic and diastolic function in responders to therapy [ Time Frame: 0, 3 and 6 months ]
  • LV mass in responders [ Time Frame: 0, 3 and 6 months ]
  • Change in 6-minute walk distance in responders [ Time Frame: 0, 3, and 6 months ]

Secondary Outcome Measures:
  • Correlation between interval improvement or deterioration in Framingham score and corresponding change in echocardiographic classification in all subjects [ Time Frame: 3 and 6 months ]
  • Correlation between interval improvement or deterioration in LV Mass and corresponding change in 6 minute walk distance and diastolic function in all subjects [ Time Frame: 3 and 6 months ]

Enrollment: 38
Study Start Date: November 2003
Study Completion Date: March 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Diuretic-Based Hypertension Therapy
Drug: Diuretic-Based or Non-Diuretic Based Hypertension Therapy
Active Comparator: 2
Non-Diuretic-Based Hypertension Therapy
Drug: Diuretic-Based or Non-Diuretic Based Hypertension Therapy

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.
  Eligibility

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20-65 years;
  2. Hypertension with average 24-hour BP of >130 mmHg systolic or >80 mmHg diastolic in spite of treatment with one medication;
  3. Office systolic blood pressure >140 mmHg and less than 180mmHg;
  4. Able to comprehend and sign the consent form;
  5. Able to tolerate either hydrochlorothiazide 25 mg or amlodipine 5 mg daily for 3 weeks during the run-in phase.

Exclusion Criteria:

  1. Diagnosis of secondary hypertension;
  2. Hypertension with systolic BP >180 mmHg in spite of 1 medication;
  3. Chronic heart failure requiring diuretics, Angina or coronary syndrome requiring anti-angina therapy with CCB or beta blockers, or more than 0.4 mg/hr nitroglycerine patch;
  4. Left Ventricular Ejection Fraction (LVEF) <20% or LV end systolic dimension >75 mm;
  5. Significant valvular disease such as; more than mild disease of aortic or mitral valve;
  6. Technically sub-optimal acoustic window or regional wall motion abnormalities;
  7. Patients currently on both CCB and diuretics for more than 4 weeks;
  8. Normal 24 hour ABPM at the end of the run-in period;
  9. Physical handicap that precludes adequate performance of 6-minute walk such as arthritis;
  10. Concomitant comorbidity that might compromise ability to evaluate treatment or enhance risks of therapy, such as: atrial fibrillation with resting ventricular rate of >100 bpm; morbid obesity; uncontrolled diabetes mellitus; severe chronic obstructive pulmonary disease (COPD); hypertrophic cardiomyopathy; and documented history of non-compliance with treatment;
  11. Any condition or disorder other than hypertension that: Requires prolonged hospitalization; May limit life expectancy within 2 years; would increase the risk of participation to the subject (in the opinion of the investigator).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229242


Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Pfizer
Investigators
Principal Investigator: Kofo O Ogunyankin, MD, FACC Queen's University
  More Information

Additional Information:
Publications:
Responsible Party: Dr Kofo Ogunyankin, Queens University
ClinicalTrials.gov Identifier: NCT00229242     History of Changes
Other Study ID Numbers: DMED-676-03
First Submitted: September 13, 2005
First Posted: September 29, 2005
Last Update Posted: December 14, 2009
Last Verified: December 2009

Keywords provided by Queen's University:
Ambulatory blood pressure monitoring
Echocardiography
Diastolic function
Left ventricular mass regression

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs