Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
- Registration Number
- NCT00138944
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
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.
- Detailed Description
see above
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Casual blood pressure >=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic
- Contraindication for eplerenone
- Creatinine-Clearance < 60 ml/min
- Diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Placebo 2 eplerenone Eplerenone
- Primary Outcome Measures
Name Time Method Change of left ventricular mass 3 months vs. baseline MRT assessment of left ventricular mass
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CRC Medical Department IV
🇩🇪Erlangen, Germany