Does the ALDOsterone:RENin ratio predict the efficacy of spironolactone over bendroflumethiazide in hypertension?

inewells Hospital & Medical School (UK)0 个研究点目标入组 120 人开始时间: 2007年4月13日最近更新: 2018年10月22日

适应症

试验速览

•1. Mild-to-moderate hypertension with daytime mean Ambulatory Blood Pressure Monitoring (ABPM) systolic Blood Pressure (BP) greater than 140 mmHg
•2. Either untreated or on stable treatment for at least two weeks
•3. Either:
•a. aldosterone:renin ratio greater than 750 and plasma aldosterone greater than 250 pmol/l, or
•b. aldosterone:renin ratio less than 300 and plasma renin activity less than 10 ng/ml/h
•4. No clinically significant abnormalities on screening laboratory results
•5. Written informed consent

•1. Females of child-bearing potential not using reliable contraception
•2. Subjects on more than four classes of anti-hypertensive drugs at screening
•3. Secondary hypertension other than hyperaldosteronism
•4. Addison?s disease
•5. Severe or malignant hypertension
•6. Subjects who take and are unable to discontinue taking a thiazide diuretic or potassium sparing diuretic
•7. Serum potassium less than 3.3 or greater than 5 mmol/l two weeks after discontinuing diuretics
•8. Serum creatinine greater than 160 µmol/l
•9. Subjects intolerant of spironolactone or thiazide diuretics
•10. Subjects who have taken spironolactone or potassium canrenoate in the previous three months
•11. Previous Myocardial Infarction (MI) or Cardiovascular Accident (CVA)
•12. Chronic Heart Failure (CHF)
•13. Any condition that would:
•a. interfere with the ability to provide informed consent
•b. place at increased risk
•c. confound interpretation of results

发起方

inewells Hospital & Medical School (UK)