NCT01069510

Brief Summary

The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function. Subjects from the study titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle will be asked to take part in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_2

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, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 21, 2019

Completed
Last Updated

August 21, 2019

Status Verified

July 1, 2019

Enrollment Period

6.3 years

First QC Date

February 16, 2010

Results QC Date

July 30, 2019

Last Update Submit

July 30, 2019

Conditions

Congenital Heart DiseaseHeart FailureEndomyocardial Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Extracellular Volume Fraction

    extracellular volume fraction measured by T1 mapping with MRI

    12 month

Secondary Outcomes (2)

  • 6-minute Walk Distance

    12 month

  • Procollagen 3 NT Peptide

    12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will receive placebo

Other: Placebo

Spironolactone

EXPERIMENTAL

Spironolactone 25 mg daily

Drug: Spironolactone 25mg

Interventions

Spironolactone 25mgDRUG

Spironolactone 25 mg daily for 12 months

Also known as: Aldactone 25 mg daily
Spironolactone
PlaceboOTHER

Placebo daily for 12 months

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fibrosis index ≥29%, or
  • Evidence of cardiovascular dysfunction including any of the following:
  • Systemic ejection fraction \<55%,
  • NYHA 2-3
  • minute walk distance \<500 m.
  • Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.

You may not qualify if:

  • Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
  • Serum potassium ≥5.0 mmol/L at the initial visit, if not taking potassium supplements. Patients will be eligible if a repeat potassium is \<5.0 mmol/L after potassium supplements have been discontinued.
  • Moderate/severe systemic atrioventricular valve regurgitation,
  • Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
  • Unwilling to commit to return visits including mandatory blood draws for potassium,
  • Renal insufficiency (estimated creatinine clearance \< 30 ml/min/1.73m2),
  • Positive urine pregnancy test.
  • Any contraindication to MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Heart Defects, CongenitalHeart FailureEndomyocardial Fibrosis

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiomyopathies

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Craig Broberg
Organization
Oregon Health and Science Univ.
brobergc@ohsu.edu
503-494-7400

Study Officials

  • Craig Broberg, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2016

Study Completion

March 1, 2017

Last Updated

August 21, 2019

Results First Posted

August 21, 2019

Record last verified: 2019-07

Locations

US(1)