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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
  Purpose
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 Intervention Phase
Primary Hypertension Drug: spironolactone Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • left ventricular mass [ Time Frame: 8 weeks ]

Enrollment: 50
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
spironolactone
Drug: spironolactone
25mg per oral once daily
Placebo Comparator: 2
placebo
Drug: placebo
placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865501


Locations
Germany
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
  More Information

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00865501     History of Changes
Other Study ID Numbers: KFO-TP5-I
First Submitted: March 18, 2009
First Posted: March 19, 2009
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by University of Erlangen-Nürnberg Medical School:
primary hypertension
aldosterone
left ventricular hypertrophy

Additional relevant MeSH terms:
Hypertension
Heart Diseases
Vascular Diseases
Cardiovascular Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents