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NCT00865501 Clinical Trial

Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

Primary Hypertension Clinical Trial

Official title:
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00865501
Other study ID # KFO-TP5-I
Secondary ID
Status Completed
Phase Phase 3
First received March 18, 2009
Last updated July 6, 2012
Start date March 2008
Est. completion date December 2009

Study information
Verified date July 2012
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

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).

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• spironolactone
25mg per oral once daily
• placebo
placebo

Locations
Country Name City State
Germany University Erlangen-Nürnberg, Nephrology and Hypertension 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 left ventricular mass 8 weeks No
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