NCT00548912

Brief Summary

The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

October 23, 2007

Last Update Submit

November 29, 2021

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, ChronicHemodialysisSpironolactone

Outcome Measures

Primary Outcomes (1)

  • Left ventricular mass

    9 months

Study Arms (1)

1 group - no arms

OTHER

no arm just error message

Drug: Spironolactone

Interventions

SpironolactoneDRUG
1 group - no arms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemodialysis patients

You may not qualify if:

  • non compliance
  • hyperkalemia
  • pregnancy
  • expected survival less than 9 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Richard Marcus

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nephrolgist, Co-Investigator

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations

US(1)