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Effectiveness of Eplerenone to Improve Target Organ Damage in Patients with Resistant Arterial Hypertension - Article


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Hypertension

High Blood Pressure; Hypertension/High Blood Pressure


Clinical Trial: Effectiveness of Eplerenone to Improve Target Organ Damage in Patients with Resistant Arterial Hypertension

This study is currently recruiting patients.
Verified by University of Erlangen-Nürnberg August 2005

Sponsored by: University of Erlangen-Nürnberg
Information provided by: University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT00138944

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: Eplerenone
Phase III

MedlinePlus related topics:  High Blood Pressure

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
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 (Cockroft-Gault formula)
  • Diabetes mellitus

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00138944

Roland E Schmieder, MD      +49-9131-85-  Ext. 36245    roland.schmieder@rzmail.uni-erlangen.de
Bernhard MW Schmidt, MD      +49-911-398  Ext. 3119    bernhardmwschmidt@yahoo.com

Germany
      CRC Medical Department IV, Erlangen,  91054,  Germany; Recruiting
Roland E Schmieder, MD  +49-9131-85  Ext. 36245    roland.schmieder@rzmail.uni-erlangen.de 
Roland E Schmieder, MD,  Principal Investigator
Bernhard MW Schmidt, MD,  Sub-Investigator

Study chairs or principal investigators

Roland E Schmieder, MD,  Study Chair,  University Erlangen-Nuremberg   

More Information

Study ID Numbers:  KFO_TP5/2; DFG KFO 106-2 TP5
Last Updated:  August 29, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00138944
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-30


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Page Updated: December 9, 2005
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