Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Essential Hypertension Clinical Trial

Official title:

Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138944
• Other study ID #: KFO_TP5/2
• Secondary ID: DFG KFO 106-2 TP
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: April 16, 2013
• Start date: January 2007
• Est. completion date: July 2008

Study information

• Verified date: April 2013
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

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

• Diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• placebo
od
• eplerenone
50mg od

Locations

Country	Name	City	State
Germany	CRC Medical Department IV	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of left ventricular mass	MRT assessment of left ventricular mass	3 months vs. baseline	No