The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

Essential Hypertension Clinical Trial

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Official title:

The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195805
• Other study ID #: MED.RES.HOS.2010.03.SKM
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: August 19, 2015
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: March 2013
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.

Description:

Purpose of the study is to examine the effect of amiloride and spironolactone on

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

2. Pulsewave velocity, augmentation index central bloodpressure,

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

4. Ambulatory bloodpressure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• hypertension,

• BMI 18,5-30,

• non-smoker

Exclusion Criteria:

• Smoking

• Not using contraceptives

• Other illnesses

• Drug or alcohol abuse

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Spironolactone
1 tablet twice a day for 28 days

Other:
• Placebo
1 tablet twice a day for 28 days

Drug:
• Amiloride
1 tablet twice a day for 28 days

Locations

Country	Name	City	State
Denmark	Departments of medical research and medicine	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bloodpressure		24-hours and examination	No