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The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables (hass)

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ClinicalTrials.gov Identifier: NCT01195805
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : August 20, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Essential Hypertension Drug: Spironolactone Other: Placebo Drug: Amiloride

Detailed Description:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.
Study Start Date : August 2010
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Amiloride Drug: Amiloride
1 tablet twice a day for 28 days
Active Comparator: Spironolactone Drug: Spironolactone
1 tablet twice a day for 28 days
Placebo Comparator: Placebo
1 tablet twice a day for 28 days
Other: Placebo
1 tablet twice a day for 28 days

Outcome Measures

Primary Outcome Measures :
  1. Bloodpressure [ Time Frame: 24-hours and examination ]

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking
  • Not using contraceptives
  • Other illnesses
  • Drug or alcohol abuse
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01195805

Departments of medical research and medicine
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Principal Investigator: Solveig K Matthesen, MD Departments of medical research and medicine
More Information

Responsible Party: Erling Bjerregaard Pedersen, professor, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01195805     History of Changes
Other Study ID Numbers: MED.RES.HOS.2010.03.SKM
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: March 2013

Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
Blood pressure, PWV, HRV, PWV, potassium

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