Text Size

Spironolactone in Adult Congenital Heart Disease

This study is currently recruiting participants.
Verified January 2010 by Oregon Health and Science University
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Clinical and Translational Research Institute
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01069510
First received: February 16, 2010
Last updated: July 21, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Heart Disease
Heart Failure
Endomyocardial Fibrosis
 Drug: Spironolactone
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Heart Failure in Congenital Heart Disease: the Role of Myocardial Fibrosis. Treatment Sub-Study: Spironolactone vs. Placebo

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • "Fibrosis Index" or the volume of distribution of gadolinium in the myocardium measured by MRI. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: February 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo daily for 12 months
Experimental: Spironolactone
Spironolactone 25 mg daily
 Drug: Spironolactone
Spironolactone 25 mg daily for 12 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069510

Contacts
Contact: Craig Broberg, MD 503-494-8750 brobergc@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Craig S Broberg, MD     503-494-8750     brobergc@ohsu.edu    
Contact: Jennifer Bishop     503-494-7399     bishopj@ohsu.edu    
Principal Investigator: Craig Broberg, MD            
Sponsors and Collaborators
Oregon Health and Science University
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Clinical and Translational Research Institute
Investigators
Principal Investigator: Craig Broberg, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Craig Broberg, MD - Assistant Professor, Department of Cardiology, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01069510     History of Changes
Other Study ID Numbers: eIRB 5845
Study First Received: February 16, 2010
Last Updated: July 21, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Fibrosis
Heart Diseases
Heart Failure
Heart Defects, Congenital
Endomyocardial Fibrosis
Pathologic Processes
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Cardiomyopathies
 Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013