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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Spironolactone
Placebo
Amiloride
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Blood pressure, PWV, HRV, PWV, potassium

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking
  • Not using contraceptives
  • Other illnesses
  • Drug or alcohol abuse

Sites / Locations

  • Departments of medical research and medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Amiloride

Spironolactone

Placebo

Arm Description

1 tablet twice a day for 28 days

Outcomes

Primary Outcome Measures

Bloodpressure

Secondary Outcome Measures

Full Information

First Posted
September 3, 2010
Last Updated
August 19, 2015
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT01195805
Brief Title
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables
Acronym
hass
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 Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Purpose of the study is to examine the effect of amiloride and spironolactone on Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK), Pulsewave velocity, augmentation index central bloodpressure, Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and Ambulatory bloodpressure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Blood pressure, PWV, HRV, PWV, potassium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amiloride
Arm Type
Active Comparator
Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
1 tablet twice a day for 28 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 tablet twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Amiloride
Intervention Description
1 tablet twice a day for 28 days
Primary Outcome Measure Information:
Title
Bloodpressure
Time Frame
24-hours and examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hypertension, BMI 18,5-30, non-smoker Exclusion Criteria: Smoking Not using contraceptives Other illnesses Drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Solveig K Matthesen, MD
Organizational Affiliation
Departments of medical research and medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departments of medical research and medicine
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

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The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

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