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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00138944
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date April 17, 2013
Study Start Date  ICMJE January 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2013)
Change of left ventricular mass [ Time Frame: 3 months vs. baseline ]
MRT assessment of left ventricular mass
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00138944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
Official Title  ICMJE Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE
  • Drug: placebo
    od
  • Drug: eplerenone
    50mg od
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: placebo
  • Active Comparator: 2
    Eplerenone
    Intervention: Drug: eplerenone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2013)
85
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00138944
Other Study ID Numbers  ICMJE KFO_TP5/2
DFG KFO 106-2 TP5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roland E Schmieder, MD University Erlangen-Nuremberg
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP