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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01388088
First received: May 19, 2010
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    24 hours blood pressure measurements


Secondary Outcome Measures:
  • Pulse wave velocity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388088

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

No publications provided

Responsible Party: Erling Bjerregaard Pedersen, Proffesor, Regional Hospital Holstebro
ClinicalTrials.gov 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
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Regional Hospital Holstebro:
Hypertension
Potassium
Blood-pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Spironolactone
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013