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
|
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
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
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, Principal Investigator
Bernhard MW Schmidt, MD, Sub-Investigator
Roland E Schmieder, MD, Study Chair, University Erlangen-Nuremberg
More Information
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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