The Effect of Amiloride and Spironolactone in Healthy Persons

Phase 1

Completed

• Conditions: High Blood Pressure
• Interventions: Drug: Spironolactone; Drug: Placebo; Drug: Amiloride; Drug: Placebo and spironolactone

• Registration Number: NCT00857909
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

This study will investigate whether retaining potassium in the body will lead to changes in blood pressure and changes in blood and urine samples.

Detailed Description

The purpose is to measure the effect of amiloride and spironolactone on:

1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),

2. Pulsbewave velocity, augmentation index and central blood pressure,

3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and

4. Ambulatory blood pressure

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy
• Non-smokers

Exclusion Criteria

• Smoking
• Under medical treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Randomisation 2	Spironolactone	Spironolactone 25 mg twice daily, to be compared with placebo and amiloride
Placebo	Placebo	calcium tablet
Randomisation 1	Amiloride	Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo
Randomisation 1	Placebo and spironolactone	Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo

Primary Outcome Measures

Name	Time	Method
Blood pressure	2 years

Trial Locations

Locations (1)

Medical Research; 🇩🇰 Holstebro, Denmark