Renin angiotensin Aldosterone (RAAS) axis, endothelial function and hypertension: diagnostic strategies and therapeutic role of potassium supplementatio

Phase 1

• Conditions: We are seeking to determine the effects of potassium supplementation vs placebo for 6 weeks on the renin-angiotensin-aldosterone axis and also endothelial function in subjects with 10-20% 10 year cardiovascular risk.

• Registration Number: EUCTR2008-001738-29-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-21
• Study Completion: 2011-08-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

50–70 years old with a 10-20% cardiovascular disease risk , (BMI) < 30 kg/m2, a (fasting plasma) glucose less than 7mmol/l, plasma potassium less than 5mmol/l, normal renal function (eGFR > 60), a treated BP < 140/85 mmHg and a 24hour urinary sodium >100mmol/24hrs.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion - history of renal or cardio vascular disease,fasting glucose greater than or equal to 7mmol/l, interfering medications with the RAAS axis (namely diuretics, ACE inhibitors, angiotensin receptor blockers, aldosterone antagonists, calcium blockers or beta-blockers). Patients on HRT will also be excluded. Given the age of inclusion, pregnancy is unlikely however pregnant or lactating women will also be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine in a randomised single blinded crossover study the effect of potassium supplementation on global endothelial function;Secondary Objective: To determine the effect of potassium supplementation on the renin-aldosterone axis and on markers of vascular inflammation;Primary end point(s): Global endothelial function as assessed by pulse wave analysis at baseline and after salbutamol and GTN stimulation tests