Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension|
- Change of left ventricular mass [ Time Frame: 3 months vs. baseline ] [ Designated as safety issue: No ]MRT assessment of left ventricular mass
|Study Start Date:||January 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Active Comparator: 2
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138944
|CRC Medical Department IV|
|Erlangen, Germany, 91054|
|Study Chair:||Roland E Schmieder, MD||University Erlangen-Nuremberg|