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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00138944
First Posted: August 30, 2005
Last Update Posted: April 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
  Purpose

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.


Condition Intervention Phase
Essential Hypertension Drug: placebo Drug: eplerenone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Roland E. Schmieder, University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Change of left ventricular mass [ Time Frame: 3 months vs. baseline ]
    MRT assessment of left ventricular mass


Enrollment: 85
Study Start Date: January 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: placebo
od
Active Comparator: 2
Eplerenone
Drug: eplerenone
50mg od

Detailed Description:
see above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138944


Locations
Germany
CRC Medical Department IV
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Chair: Roland E Schmieder, MD University Erlangen-Nuremberg
  More Information

Responsible Party: Roland E. Schmieder, Prof. Dr. med., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00138944     History of Changes
Other Study ID Numbers: KFO_TP5/2
DFG KFO 106-2 TP5
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Roland E. Schmieder, University of Erlangen-Nürnberg Medical School:
Essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eplerenone
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents