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

Regional Hospital Holstebro

Status and phase: Completed; Phase 1

Conditions: High Blood Pressure

Treatments: Drug: Spironolactone; Drug: Placebo and spironolactone; Drug: Amiloride; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00857909

MED.RES:HOS:SKM.02.2009

Details and patient eligibility

About

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

Full description

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

Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK), Pulsbewave velocity, augmentation index and central blood pressure, Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and Ambulatory blood pressure

Enrollment: 30 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Non-smokers

Exclusion criteria

• Smoking
• Under medical treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Randomisation 1

Active Comparator group

Description:

Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo

Treatment:

Drug: Amiloride

Drug: Placebo and spironolactone

Randomisation 2

Active Comparator group

Description:

Spironolactone 25 mg twice daily, to be compared with placebo and amiloride

Treatment:

Drug: Spironolactone

Placebo

Placebo Comparator group

Description:

calcium tablet

Treatment:

Drug: Placebo