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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01388088
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : March 28, 2012
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Drug: Spironolactone Drug: Amiloride Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 23 participants
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.
Study Start Date : September 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01388088

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

Responsible Party: Erling Bjerregaard Pedersen, Proffesor, Regional Hospital Holstebro Identifier: NCT01388088     History of Changes
Other Study ID Numbers: MED.RES.HOS.2010.02.SKM
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 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