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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Collaborator: Pfizer
• Treatments: Diuretics

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).