The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

NCT ID: NCT01195805

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Amiloride

Group Type ACTIVE_COMPARATOR

Amiloride

Intervention Type DRUG

1 tablet twice a day for 28 days

Spironolactone

Group Type ACTIVE_COMPARATOR

Spironolactone

Intervention Type DRUG

1 tablet twice a day for 28 days

Placebo

1 tablet twice a day for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 tablet twice a day for 28 days

Interventions

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Spironolactone

1 tablet twice a day for 28 days

Intervention Type DRUG

Placebo

1 tablet twice a day for 28 days

Intervention Type OTHER

Amiloride

1 tablet twice a day for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* hypertension,
* BMI 18,5-30,
* non-smoker

Exclusion Criteria

* Smoking
* Not using contraceptives
* Other illnesses
* Drug or alcohol abuse
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Erling Bjerregaard Pedersen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Solveig K Matthesen, MD

Role: PRINCIPAL_INVESTIGATOR

Departments of medical research and medicine

Locations

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Departments of medical research and medicine

Holstebro, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MED.RES.HOS.2010.03.SKM

Identifier Type: -

Identifier Source: org_study_id

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