Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT00138944|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : April 17, 2013
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 or disease||Intervention/treatment||Phase|
|Essential Hypertension||Drug: placebo Drug: eplerenone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||July 2008|
Placebo Comparator: 1
Active Comparator: 2
- Change of left ventricular mass [ Time Frame: 3 months vs. baseline ]MRT assessment of left ventricular mass
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
|CRC Medical Department IV|
|Erlangen, Germany, 91054|
|Study Chair:||Roland E Schmieder, MD||University Erlangen-Nuremberg|