Spironolactone in Adult Congenital Heart Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/7/2017 |
| Start Date: | February 2010 |
| End Date: | March 2017 |
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.
(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.
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.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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