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Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00865501
First received: March 18, 2009
Last updated: July 6, 2012
Last verified: July 2012

March 18, 2009
July 6, 2012
March 2008
December 2009   (final data collection date for primary outcome measure)
left ventricular mass [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865501 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular organ damage caused by arterial hypertension. This study aims at evaluating the importance of aldosterone with regard to hypertension induced damage to the heart. In order to do this the investigators will perform a comparative cross-sectional study in hypertensives and normotensives. In addition as interventional part the hypertensives will be treated with a mineralocorticoid-receptor blocker (spironolactone).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Hypertension
  • Drug: spironolactone
    25mg per oral once daily
  • Drug: placebo
    placebo
  • Experimental: 1
    spironolactone
    Intervention: Drug: spironolactone
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis hypertension (BP higher than 139/89)

Exclusion Criteria:

  • Antihypertensive pretreatment
  • Contraindications against spironolactone
  • Being unable to understand or comply with study procedures
Male
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00865501
KFO-TP5-I
Yes
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
Principal Investigator: Roland E Schmieder, MD, FACP Universität Erlangen-Nurnberg
University of Erlangen-Nürnberg Medical School
July 2012

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