Status:
COMPLETED
Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures
Lead Sponsor:
Queen's University
Collaborating Sponsors:
Pfizer
Conditions:
Hypertension
Eligibility:
All Genders
15-65 years
Phase:
NA
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 ...
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 ide...
Eligibility Criteria
Inclusion
- Age 20-65 years;
- Hypertension with average 24-hour BP of \>130 mmHg systolic or \>80 mmHg diastolic in spite of treatment with one medication;
- Office systolic blood pressure \>140 mmHg and less than 180mmHg;
- Able to comprehend and sign the consent form;
- Able to tolerate either hydrochlorothiazide 25 mg or amlodipine 5 mg daily for 3 weeks during the run-in phase.
Exclusion
- Diagnosis of secondary hypertension;
- Hypertension with systolic BP \>180 mmHg in spite of 1 medication;
- 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;
- Left Ventricular Ejection Fraction (LVEF) \<20% or LV end systolic dimension \>75 mm;
- Significant valvular disease such as; more than mild disease of aortic or mitral valve;
- Technically sub-optimal acoustic window or regional wall motion abnormalities;
- Patients currently on both CCB and diuretics for more than 4 weeks;
- Normal 24 hour ABPM at the end of the run-in period;
- Physical handicap that precludes adequate performance of 6-minute walk such as arthritis;
- 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;
- 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).
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00229242
Start Date
November 1 2003
End Date
March 1 2007
Last Update
December 14 2009
Active Locations (1)
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1
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7