Efficacy of Chlorthalidone and Hydrochlorothiazide Combined With Amiloride on Blood Pressure in Primary Hypertension.

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, safety profile and low cost, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Besides, concernments about adverse metabolic effects such as hypokalemia, hyperglycemia and hyperlipidemia do exist, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. In addition to control adverse effects of thiazides, amiloride could offer an additional blood pressure lowering effect, but the efficacy of different doses was not fully established. This study aims to investigate the blood pressure lowering efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborator: Instituto de Cardiologia do Rio Grande do Sul
• Treatments: Amiloride; Chlorthalidone; Hydrochlorothiazide

Criteria

Inclusion Criteria:

• Adults (age 30 to 75 years).

• Diagnosis of primary hypertension based on ABPM (mean 24-h systolic BP ≥130 mmHg or mean 24-h diastolic BP ≥80 mmHg).

• No current use of antihypertensive medication.

Exclusion Criteria:

• Low life expectancy.

• Other indications for the use of diuretics.

• Intolerance or contraindications to the study drugs.

• Cardiovascular disease (heart failure, myocardial infarction or stroke).

• Secondary hypertension.

• Chronic kidney disease and / or abnormal renal function (creatinine >1.5 mg/dL).

• Hyperkalemia (serum potassium >5.5 mEq/L).

• Gout.

• Previous antihypertensive treatment with more than one drug.

• Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg measured through office blood pressure.

• Pregnancy or prospective pregnancy during the study.

• Lactating women.