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Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00865501
First Posted: March 19, 2009
Last Update Posted: July 10, 2012
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.
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
March 18, 2009
March 19, 2009
July 10, 2012
March 2008
December 2009   (Final data collection date for primary outcome measure)
left ventricular mass [ Time Frame: 8 weeks ]
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00865501
KFO-TP5-I
Yes
Not Provided
Not Provided
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