Left Ventricular Hypertrophy and Spironolactone in End St... | NCT00548912

Studies
Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

NCT00548912

Sponsor

Dawnmarie DeFazio

Status

Withdrawn

Last Update Posted

Dec 9, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Kidney Failure, Chronic

Interventions

Spironolactone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study ended

Expanded Access Info

Start Date

Oct 2007Actual

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Oct 23, 2007

First Submission Date that Met QC Criteria

Oct 23, 2007

First Posted Date

Oct 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2021

Last Update Posted Date

Dec 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dawnmarie DeFazio, Nephrolgist, Co-Investigator, West Penn Allegheny Health SystemSponsor-Investigator

Lead Sponsor

Dawnmarie DeFazioOTHER

Collaborators

Not provided

Description Module

Brief Summary

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

Detailed Description

Dialysis patients have significant morbidity and mortality associated with left ventricular hypertrophy and cardiac failure. Aldosterone may have an important role in the development of myocardial hypertrophy and remodeling. Animal studies have demonstrated beneficial effects of aldosterone antagonists on myocardial hypertrophy, and human studies have shown significant survival benefit in a non-dialysis population with congestive heart failure. This study evaluates the effect of spironolactone (an aldosterone receptor antagonist) on cardiac hypertrophy in the end-stage renal disease population.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 group - no arms	Other	no arm just error message	Drug: Spironolactone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spironolactone	Drug		1 group - no arms

Measure	Description	Time Frame
Left ventricular mass		9 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hemodialysis patients

Exclusion Criteria:

non compliance
hyperkalemia
pregnancy
expected survival less than 9 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Marcus	West Penn Allegheny Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allegheny General Hospital		Pittsburgh	Pennsylvania	15212	United States

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013148	Spironolactone

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256

Browse Leaves

Not provided

Browse Branches

Not provided