The Effect of Amiloride and Spironolactone in Patients With Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Spironolactone; Drug: Amiloride; Drug: Placebo

• Registration Number: NCT01388088
• Lead Sponsor: Erling Bjerregaard Pedersen

Brief Summary

The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone.

The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.

Detailed Description

Purpose of the study is to examine the effect of amilorid and spironolacton on

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

2. Pulsewavevelocity, augmentation index and centralt bloodpressure,

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

4. Ambulatory blood pressure

Study Timeline

• Study First Submitted: 2010-05-19
• Study Start: 2010-09
• Study First Submitted QC: 2011-07-03
• Study First Posted: 2011-07-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Hypertension
• Age 45-70
• BMI: 18,5-30

Exclusion Criteria

• Other diseases
• Drug or alcohol abuse
• Abnormal findings in the screening procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spironolactone	Spironolactone	Increases the level of potassium
Amiloride	Amiloride	Increases the level of potassium
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Blood pressure	2 years	24 hours blood pressure measurements

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity	2 years	We will investigate the changes in cardiovascular variables using a Sphygmocor scanner.

Trial Locations

Locations (1)

Department of Medical Research; 🇩🇰 Holstebro, Denmark