Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507819
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2007-07-25
Brief Title:
Sildenafil After the Fontan Operation
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
The Sildenafil After Fontan Operation Study
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFO
Brief Summary:
In this study the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation The investigators will also evaluate echocardiographic measures of ventricular function and measure quality of life changes using two validated quality of life measures The hypothesis is that sildenafil will result in increased exercise tolerance in patients who have had the Fontan operation as compared to placebo
Detailed Description:
The Fontan physiology is the end result of staged reconstruction of the heart and the major blood vessels in patients who have a single ventricle After completion of the reconstruction the great veins which usually bring blood back to the heart are connected directly to the pulmonary arteries allowing blood from the body to bypass the heart and flow directly into the lungs In this system blood flow through the lungs is passive not pumped and the efficiency of flow through the cardiovascular system is related to the resistance to blood flow in the vessels of the lungs
There are two potential problems that arise in this scenario as a result of the resistance to blood flow in the vessels of the lungs First the amount of blood flow returning to the heart from the lungs may not be sufficient to allow the heart to function at maximum efficiency compromising the hearts ability to keep up with the demands of the body Second if the resistance to blood flow in the lungs is high pressure may be transmitted back into the great veins themselves and secondarily into the organs of the body causing mild or sometimes significant organ dysfunction Not all patients with the Fontan physiology develop these problems but we know that even in patients without obvious problems the ability to keep up with an increased metabolic demand as during exercise in compromised
Improving the efficiency of blood flow through the lungs should improve the return of blood to the heart and thereby diminish the pressure transmitted back to the vessels which passively deliver blood to the lungs We believe that this change may manifest as diminished symptoms in those patients with known difficulties or may allow for an increased ability to walk run or participate in sports in those without any overt symptoms Most importantly we speculate that improved efficiency of flow through the lungs and the resulting improved cardiac output blood flow through the body will make patients more energetic and will make them feel better
Sildenafil is an oral medication that has been used to treat patients with pulmonary hypertension a disease in which there is abnormally elevated pressure in the vessels of the lung In this disease the resistance in the lungs is abnormally high severely limiting the ability of the heart to keep up with the demands of the body Sildenafil lowers the resistance in the vessels of the lungs and has been shown to improve exercise performance in patients with this disease We believe that Sildenafil may have a similar benefit for our patients after Fontan operation in whom cardiac output is also limited by resistance of the blood vessels in the lungs
In our study we will compare the exercise capacity echocardiographic measures of cardiac function and the overall quality of life in patients with the Fontan before and after a six-week period of sildenafil administration As a control the same group of patients will take a placebo for a six-week period also with before and after testing We hypothesize that oral sildenafil will result in significant improvements in exercise capacity energy levels and echocardiographic measures of cardiac function and output in our study participants We are hopeful that the findings of this investigation will directly help children and young adults with Fontan physiology
There are two potential problems that arise in this scenario as a result of the resistance to blood flow in the vessels of the lungs First the amount of blood flow returning to the heart from the lungs may not be sufficient to allow the heart to function at maximum efficiency compromising the hearts ability to keep up with the demands of the body Second if the resistance to blood flow in the lungs is high pressure may be transmitted back into the great veins themselves and secondarily into the organs of the body causing mild or sometimes significant organ dysfunction Not all patients with the Fontan physiology develop these problems but we know that even in patients without obvious problems the ability to keep up with an increased metabolic demand as during exercise in compromised
Improving the efficiency of blood flow through the lungs should improve the return of blood to the heart and thereby diminish the pressure transmitted back to the vessels which passively deliver blood to the lungs We believe that this change may manifest as diminished symptoms in those patients with known difficulties or may allow for an increased ability to walk run or participate in sports in those without any overt symptoms Most importantly we speculate that improved efficiency of flow through the lungs and the resulting improved cardiac output blood flow through the body will make patients more energetic and will make them feel better
Sildenafil is an oral medication that has been used to treat patients with pulmonary hypertension a disease in which there is abnormally elevated pressure in the vessels of the lung In this disease the resistance in the lungs is abnormally high severely limiting the ability of the heart to keep up with the demands of the body Sildenafil lowers the resistance in the vessels of the lungs and has been shown to improve exercise performance in patients with this disease We believe that Sildenafil may have a similar benefit for our patients after Fontan operation in whom cardiac output is also limited by resistance of the blood vessels in the lungs
In our study we will compare the exercise capacity echocardiographic measures of cardiac function and the overall quality of life in patients with the Fontan before and after a six-week period of sildenafil administration As a control the same group of patients will take a placebo for a six-week period also with before and after testing We hypothesize that oral sildenafil will result in significant improvements in exercise capacity energy levels and echocardiographic measures of cardiac function and output in our study participants We are hopeful that the findings of this investigation will directly help children and young adults with Fontan physiology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None