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

This study has been completed.
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro Identifier:
First received: September 3, 2010
Last updated: August 19, 2015
Last verified: March 2013
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 Intervention
Essential Hypertension
Drug: Spironolactone
Other: Placebo
Drug: Amiloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Bloodpressure [ Time Frame: 24-hours and examination ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: August 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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 Identifier: NCT01195805     History of Changes
Other Study ID Numbers: MED.RES.HOS.2010.03.SKM 
Study First Received: September 3, 2010
Last Updated: August 19, 2015
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Acid Sensing Ion Channel Blockers
Diuretics, Potassium Sparing
Epithelial Sodium Channel Blockers
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Mineralocorticoid Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Channel Blockers processed this record on May 23, 2016