Back to resultsImportance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
Primary Purpose
Primary Hypertension
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
spironolactone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypertension focused on measuring primary hypertension, aldosterone, left ventricular hypertrophy
Eligibility Criteria
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
Sites / Locations
- University Erlangen-Nürnberg, Nephrology and Hypertension
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
spironolactone
placebo
Outcomes
Primary Outcome Measures
left ventricular mass
Secondary Outcome Measures
Full Information
NCT ID
NCT00865501
First Posted
March 18, 2009
Last Updated
July 6, 2012
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT00865501
Brief Title
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
Official Title
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
Keywords
primary hypertension, aldosterone, left ventricular hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
spironolactone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
spironolactone
Intervention Description
25mg per oral once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
left ventricular mass
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland E Schmieder, MD, FACP
Organizational Affiliation
Universität Erlangen-Nurnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Erlangen-Nürnberg, Nephrology and Hypertension
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
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