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NCT01388088 Clinical Trial

The Effect of Amiloride and Spironolactone in Patients With Hypertension

Hypertension Clinical Trial

— hass  

Official title:
Effect of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables in Patients With Essential Hypertension in a Doublle-blinded Randomised Placebo-controlled, Cross-over Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01388088
Other study ID # MED.RES.HOS.2010.02.SKM
Secondary ID
Status Completed
Phase Phase 4
First received May 19, 2010
Last updated March 27, 2012
Start date September 2010
Est. completion date February 2012

Study information
Verified date March 2012
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.

Description:

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

1. Renal function (GFR, u-AQP2, u-ENaCĪ², 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

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Spironolactone
25 mg twice a day
• Amiloride
5 mg twice a day
• Placebo
twice a day

Locations
Country Name City State
Denmark Department of Medical Research Holstebro

Sponsors (1)
Lead Sponsor Collaborator
Erling Bjerregaard Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure 24 hours blood pressure measurements 2 years No
Secondary Pulse wave velocity We will investigate the changes in cardiovascular variables using a Sphygmocor scanner. 2 years No
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