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Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

NCT ID: NCT00865501

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Primary Hypertension

Keywords

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primary hypertension aldosterone left ventricular hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

spironolactone

Group Type EXPERIMENTAL

spironolactone

Intervention Type DRUG

25mg per oral once daily

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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spironolactone

25mg per oral once daily

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland E Schmieder, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

Universität Erlangen-Nurnberg

Locations

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University Erlangen-Nürnberg, Nephrology and Hypertension

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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KFO-TP5-I

Identifier Type: -

Identifier Source: org_study_id