Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT00865501
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 2.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Primary Hypertension	Drug: spironolactone; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 spironolactone	Drug: spironolactone; 25mg per oral once daily
Placebo Comparator: 2 placebo	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures

1. left ventricular mass [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Erlangen-Nürnberg, Nephrology and Hypertension	Erlangen		Germany	91054

Sponsors and Collaborators

• University of Erlangen-Nürnberg Medical School

Investigators

• Principal Investigator: Roland E Schmieder, MD, FACP, Universität Erlangen-Nurnberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT00865501
• Other Study ID Numbers: KFO-TP5-I
• First Posted: Mar 19, 2009
• Last Update Posted: Jul 10, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by University of Erlangen-Nürnberg Medical School: primary hypertension; aldosterone; left ventricular hypertrophy
• Additional relevant MeSH terms: Hypertension; Heart Diseases; Essential Hypertension; Spironolactone

Study Results

No Results Posted as of Jul 10, 2012