hass: The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

• Sponsor: Regional Hospital Holstebro (Other)
• Overall Status: Completed
• CT.gov ID: NCT01195805
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 3
• Duration (Months): 60
• Patients Per Site Per Month: 0.4

Study Details

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	Phase
Essential Hypertension	Drug: Spironolactone; Other: Placebo; Drug: Amiloride	N/A

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
• Anticipated 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: Aug 1, 2010
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

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 [24-hours and examination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erling Bjerregaard Pedersen, professor, Regional Hospital Holstebro
• ClinicalTrials.gov Identifier: NCT01195805
• Other Study ID Numbers: MED.RES.HOS.2010.03.SKM
• First Posted: Sep 6, 2010
• Last Update Posted: Aug 20, 2015
• Last Verified: Mar 1, 2013

• Keywords provided by Erling Bjerregaard Pedersen, professor, Regional Hospital Holstebro: Blood pressure, PWV, HRV, PWV, potassium
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Amiloride; Spironolactone

Study Results

No Results Posted as of Aug 20, 2015