Spironolactone and Insulin Resistance in Chronic Heart Fa... | NCT00664222

Studies
Spironolactone and Insulin Resistance in Chronic Heart Failure (CHF)

NCT00664222

Sponsor

Tottori University Hospital

Status

Completed

Last Update Posted

Apr 22, 2008Estimated

Enrollment

16Actual

Phase

Phase 4

Conditions

Chronic Stable Heart Failure

Interventions

spironolactone + furosemide

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Apr 18, 2008

First Submission Date that Met QC Criteria

Apr 21, 2008

First Posted Date

Apr 22, 2008Estimated

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

Apr 21, 2008

Last Update Posted Date

Apr 22, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

Detailed Description

Diuretics is useful in CHF patients. On the other hand, they deteriorate glucose metabolism. Therefore, the purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

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

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spironolactone + furosemide	Drug	spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16weeks

Measure	Description	Time Frame
insulin resistance		16 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic stable heart failure

Exclusion Criteria:

renal dysfunction or under treatment with antidiabetic agents

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Aug 22, 2012
Reset	Sep 20, 2012
Release	Sep 25, 2012
Reset	Oct 25, 2012
Release	Nov 14, 2012
Reset	Dec 11, 2012

Submission Tracking

Estimated Results First Submitted Date

Aug 22, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 22, 2012			Sep 20, 2012
Sep 25, 2012

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013148	Spironolactone
D005665	Furosemide

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided