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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01195805
First received: September 3, 2010
Last updated: March 1, 2014
Last verified: March 2014
  Purpose

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
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking
  • Not using contraceptives
  • Other illnesses
  • Drug or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195805

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

No publications provided

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
Study First Received: September 3, 2010
Last Updated: March 1, 2014
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amiloride
Spironolactone
Acid Sensing Ion Channel Blockers
Cardiovascular Agents
Diuretics
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
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014