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Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

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ClinicalTrials.gov Identifier: NCT00865501
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : March 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

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

University Erlangen-Nürnberg, Nephrology and Hypertension
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
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 Posted: March 19, 2009    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

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

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