Spironolactone in Adult Congenital Heart Disease

This study is currently recruiting participants.
Verified April 2014 by Oregon Health and Science University
Sponsor:
Collaborators:
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Craig Broberg, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01069510
First received: February 16, 2010
Last updated: April 9, 2014
Last verified: April 2014

February 16, 2010
April 9, 2014
February 2010
June 2015   (final data collection date for primary outcome measure)
"Fibrosis Index" or the volume of distribution of gadolinium in the myocardium measured by MRI. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01069510 on ClinicalTrials.gov Archive Site
PCIIINP, PCINP, MMP-2, TIMP-1, 6-minute walk distance, ejection fraction, and degree of diastolic function [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Spironolactone in Adult Congenital Heart Disease
Heart Failure in Congenital Heart Disease: the Role of Myocardial Fibrosis. Treatment Sub-Study: Spironolactone vs. Placebo

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.

This study will include randomizing the subject to receive the study drug or placebo. Randomization will occur during visit 1.

Visit 1 will include the following:

  • Subjects will answer questions about how well they can breathe.
  • An MRI. Dye called gadolinium will be injected into the subject's vein.
  • They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
  • They will do a 6 minute walk test..
  • They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.

Subjects' will also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization. Visits 2-5 will include the following:

  • They will go to the Oregon Clinical and Translational Research Institute where 1/2 tablespoon of blood will be drawn.
  • They will do a 6 minute walk test. During this test, they will walk back and forth in a hallway. The goal is to walk as far as possible for 6 minutes. Subjects will probably get out of breath or become exhausted. If they do, they can slow down, stop, or rest as they need to. Blood pressure will be taken before the walk.
  • They will have a health review at 6 months.

Visit 6 will be identical to visit 1 and include the following:

  • Subjects will answer questions about how well they can breathe.
  • An MRI. Dye called gadolinium will be injected into the subject's vein.
  • They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
  • They will do a 6 minute walk test..
  • They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.

The investigators will compare the study drug, called spironolactone, to placebo with regard to any changes in heart stiffening and function of the heart.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Congenital Heart Disease
  • Heart Failure
  • Endomyocardial Fibrosis
  • Drug: Spironolactone
    Spironolactone 25 mg daily for 12 months
  • Other: Placebo
    Placebo daily for 12 months
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Spironolactone
    Spironolactone 25 mg daily
    Intervention: Drug: Spironolactone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
September 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Fibrosis index ≥29%, or
  2. Evidence of cardiovascular dysfunction including any of the following:

    • Systemic ejection fraction <55%,
    • NYHA 2-3
    • 6-minute walk distance <500 m.
  3. Completion of Visit 1 of the study Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" (eIRB # 3665) including meeting all inclusion for that study (Aged 18-80, Known congenital heart disease).
  4. Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.

Exclusion Criteria:

  1. Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
  2. 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.
  3. Moderate/severe systemic atrioventricular valve regurgitation,
  4. Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
  5. Unwilling to commit to return visits including mandatory blood draws for potassium,
  6. Renal insufficiency (estimated creatinine clearance < 30 ml/min/1.73m2),
  7. Positive urine pregnancy test.
  8. Any contraindication to MRI.
Both
18 Years to 80 Years
No
Contact: Craig Broberg, MD 503-494-8750 brobergc@ohsu.edu
United States
 
NCT01069510
eIRB 5845
No
Craig Broberg, Oregon Health and Science University
Oregon Health and Science University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Oregon Clinical and Translational Research Institute
Principal Investigator: Craig Broberg, MD Oregon Health and Science University
Oregon Health and Science University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP