Spironolactone in Adult Congenital Heart Disease

NCT ID: NCT01069510

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2017-03-31

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.

Detailed Description

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.

Conditions

Congenital Heart Disease; Heart Failure; Endomyocardial Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Patients will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo daily for 12 months

Spironolactone

Spironolactone 25 mg daily

Group Type: EXPERIMENTAL

Spironolactone 25mg

Intervention Type: DRUG

Spironolactone 25 mg daily for 12 months

Interventions

Spironolactone 25mg

Spironolactone 25 mg daily for 12 months

Intervention Type: DRUG

Placebo

Placebo daily for 12 months

Intervention Type: OTHER

Other Intervention Names

Aldactone 25 mg daily

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Oregon Clinical and Translational Research Institute

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Craig Broberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Broberg, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

K23HL093024-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

eIRB 5845

Identifier Type: -

Identifier Source: org_study_id