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

This study has been completed.
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro Identifier:
First received: May 19, 2010
Last updated: March 27, 2012
Last verified: March 2012

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.

Condition Intervention Phase
Hypertension Drug: Spironolactone Drug: Amiloride Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 2 years ]
    24 hours blood pressure measurements

Secondary Outcome Measures:
  • Pulse wave velocity [ Time Frame: 2 years ]
    We will investigate the changes in cardiovascular variables using a Sphygmocor scanner.

Enrollment: 23
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
twice a day

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

Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypertension
  • Age 45-70
  • BMI: 18,5-30

Exclusion Criteria:

  • Other diseases
  • Drug or alcohol abuse
  • Abnormal findings in the screening procedure
  Contacts and Locations
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Please refer to this study by its identifier: NCT01388088

Department of Medical Research
Holstebro, Denmark, 7500
Sponsors and Collaborators
Erling Bjerregaard Pedersen
Principal Investigator: Solveig K Matthesen, Cand.Med Medical Research Department
  More Information

Responsible Party: Erling Bjerregaard Pedersen, Proffesor, Regional Hospital Holstebro Identifier: NCT01388088     History of Changes
Other Study ID Numbers: MED.RES.HOS.2010.02.SKM
Study First Received: May 19, 2010
Last Updated: March 27, 2012

Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers processed this record on August 18, 2017