The Effect of Amiloride and Spironolactone in Healthy Persons (SPAS)

The Effect of Amiloride and Spironolactone Measured on Cardiovascular and Kidney Related Variables in Healthy Subjects in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study

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

Study Overview

• Status: Completed
• Conditions: High Blood Pressure
• Intervention / Treatment: Drug: Placebo; Drug: Amiloride; Drug: Placebo and spironolactone; Drug: Spironolactone; Drug: Spironolactone

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy
• Non-smokers

Exclusion Criteria:

• Smoking
• Under medical treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Randomisation 1; Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo	Drug: Amiloride; 1 tablet twice a day; Drug: Placebo and spironolactone; 5mg twice daily
Active Comparator: Randomisation 2; Spironolactone 25 mg twice daily, to be compared with placebo and amiloride	Drug: Spironolactone; 1 tablet twice a day; Drug: Spironolactone; 25mg twice daily
Placebo Comparator: Placebo; calcium tablet	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	2 years

Collaborators and Investigators

• Sponsor: Regional Hospital Holstebro
• Investigators: Principal Investigator: Erling B Pedersen, Prof, Regional Hospital Holstebro

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Estimate): July 8, 2011
• Last Update Submitted That Met QC Criteria: July 7, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Channel Blockers; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Acid Sensing Ion Channel Blockers; Epithelial Sodium Channel Blockers; Spironolactone; Amiloride
• Other Study ID Numbers: MED.RES:HOS:SKM.02.2009