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Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
placebo
eplerenone
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Casual blood pressure >=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic Exclusion Criteria: Contraindication for eplerenone Creatinine-Clearance < 60 ml/min Diabetes mellitus

Sites / Locations

  • CRC Medical Department IV

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Placebo

Eplerenone

Outcomes

Primary Outcome Measures

Change of left ventricular mass
MRT assessment of left ventricular mass

Secondary Outcome Measures

Full Information

First Posted
August 29, 2005
Last Updated
April 16, 2013
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00138944
Brief Title
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
Official Title
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not below 140/90 mmHg) with the use of adequate doses of at least three different anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible mechanism of resistance is the aldosterone-escape phenomenon. During aldosterone escape, aldosterone plasma levels are normal or even elevated despite therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH), local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood pressure independent effects on cardiac, vascular and renal damage. Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients with resistant hypertension.
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Eplerenone
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
od
Intervention Type
Drug
Intervention Name(s)
eplerenone
Intervention Description
50mg od
Primary Outcome Measure Information:
Title
Change of left ventricular mass
Description
MRT assessment of left ventricular mass
Time Frame
3 months vs. baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Casual blood pressure >=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic Exclusion Criteria: Contraindication for eplerenone Creatinine-Clearance < 60 ml/min Diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland E Schmieder, MD
Organizational Affiliation
University Erlangen-Nuremberg
Official's Role
Study Chair
Facility Information:
Facility Name
CRC Medical Department IV
City
Erlangen
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

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Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

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