Spironolactone in Adult Congenital Heart Disease

Heart Failure Clinical Trial

Official title:

Heart Failure in Congenital Heart Disease: the Role of Myocardial Fibrosis. Treatment Sub-Study: Spironolactone vs. Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069510
• Other study ID #: eIRB 5845
• Secondary ID: K23HL093024-01A1
• Status: Completed
• Phase: Phase 2
• Start date: February 2010
• Est. completion date: March 2017

Study information

• Verified date: July 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Endomyocardial Fibrosis
• Fibrosis
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure

Intervention

Drug:
• Spironolactone 25mg
Spironolactone 25 mg daily for 12 months

Other:
• Placebo
Placebo daily for 12 months

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Heart, Lung, and Blood Institute (NHLBI), Oregon Clinical and Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extracellular Volume Fraction	extracellular volume fraction measured by T1 mapping with MRI	12 month
Secondary	6-minute Walk Distance	distance walked recorded in meters after 6 minutes on flat ground	12 month
Secondary	Procollagen 3 NT Peptide		12 months