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

Not Applicable

Completed

• Conditions: Hypertension/cardiovascular diseases; Circulatory System; Hypertension

• Registration Number: ISRCTN93126600
• Lead Sponsor: inewells Hospital & Medical School (UK)

Brief Summary

1. 2007 protocol in https://www.ncbi.nlm.nih.gov/pubmed/17490489 2. 2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20009770

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-02-01
• Study Start: 2007-04-13
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the difference in mean 24-hour blood ambulatory pressure recorded at the end of each 12-week treatment period.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include the differences between the following measurements taken at the end of each 12-week treatment period:<br>1. Mean daytime ambulatory blood pressure<br>2. Mean night time ambulatory blood pressure <br>3. Mean clinic blood pressure defined as mean of mean clinic BPs on both penultimate and final days of treatment periods<br>4. Clinical biochemistry measurements of plasma potassium (K+), magnesium (Mg2+), creatinine, triglycerides, cholesterol and High Density Lipoprotein (HDL) cholesterol