The Effect of Amiloride and Spironolactone in Patients With Hypertension (hass)

March 27, 2012 updated by: Erling Bjerregaard Pedersen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

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

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holstebro, Denmark, 7500
        • Department of medical research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
twice a day
Active Comparator: Spironolactone
Increases the level of potassium
Drug: Spironolactone
25 mg twice a day
Active Comparator: Amiloride
Increases the level of potassium
Drug: Amiloride
5 mg twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 2 years
24 hours blood pressure measurements
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse wave velocity
Time Frame: 2 years
We will investigate the changes in cardiovascular variables using a Sphygmocor scanner.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erling Bjerregaard Pedersen

Investigators

  • Principal Investigator: Solveig K Matthesen, Cand.Med, Medical Research Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

July 3, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED.RES.HOS.2010.02.SKM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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