NCT00860340

Brief Summary

To determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action. Randomized, two group placebo controlled, single blind study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

3.7 years

First QC Date

March 11, 2009

Last Update Submit

December 9, 2014

Conditions

Congestive Heart Failure

Keywords

Congestive Heart FailureHemodynamicsEchocardiographs

Outcome Measures

Primary Outcomes (2)

  • Echocardiogram

    3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug

  • Measure of Kidney function and potassium levels

    This will be taken before drug, two hours after and the following day

Study Arms (1)

1

EXPERIMENTAL

Study patient will take 100mg tablet of Spironolactone

Drug: Spironolactone

Interventions

SpironolactoneDRUG

100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.

1

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CHF
  • years
  • Serum creatinine \< 2 mg/dL
  • Serum potassium 2.7 - 4.5 mg/dL measured within past 4 weeks

You may not qualify if:

  • Less than 21 years
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Ohio

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

February 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(1)