Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

This study has been completed.

First Received on March 18, 2009. Last Updated on February 1, 2010 History of Changes

Sponsor:	University of Erlangen-Nürnberg Medical School
Information provided by:	University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:	NCT00865501

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases High Blood Pressure

Drug Information available for: Spironolactone Aldosterone

U.S. FDA Resources

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

Primary Outcome Measures:

left ventricular mass [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated 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

Ages Eligible for Study:	18 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	University of Erlangen-Nürnberg, University of Erlangen-Nürnberg, Nephrology and Hypertension
ClinicalTrials.gov Identifier:	NCT00865501 History of Changes
Other Study ID Numbers:	KFO-TP5-I
Study First Received:	March 18, 2009
Last Updated:	February 1, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:

primary hypertension
aldosterone
left ventricular hypertrophy

Additional relevant MeSH terms:

Heart Diseases
Hypertension
Cardiovascular Diseases
Vascular Diseases
Spironolactone
Aldosterone Antagonists
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012