NCT00865501

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

March 18, 2009

Last Update Submit

July 6, 2012

Conditions

Primary Hypertension

Keywords

primary hypertensionaldosteroneleft ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • left ventricular mass

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

spironolactone

Drug: spironolactone

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

spironolactoneDRUG

25mg per oral once daily

1
placeboDRUG

placebo

2

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis hypertension (BP higher than 139/89)

You may not qualify if:

  • Antihypertensive pretreatment
  • Contraindications against spironolactone
  • Being unable to understand or comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Erlangen-Nürnberg, Nephrology and Hypertension

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Essential HypertensionHypertrophy, Left Ventricular

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesCardiomegalyHeart DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Roland E Schmieder, MD, FACP

    Universität Erlangen-Nurnberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

DE(1)