News | March 11, 2011

Erectile Dysfunction Drug Improves Exercise Performance in Children With Heart Disease

March 11, 2011 – Sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, has another possible use – helping children and young adults with congenital heart disease to better tolerate exercise. The drug significantly improved measures of exercise performance during stress testing in patients with single-ventricle heart disease, according to researchers from The Children's Hospital of Philadelphia.

This study was published online in the journal Circulation. It is the first randomized, double-blind, placebo-controlled, crossover trial to evaluate the impact of the drug on measures of exercise performance in children and young adults with single-ventricle heart disease.

All patients involved in the study had earlier undergone the Fontan operation, a procedure that redirects systemic venous blood directly to the pulmonary arteries, bypassing the heart. It is the third operation in a staged series of surgeries for single-ventricle heart defects, life-threatening conditions in which a child is born with severe underdevelopment of one of the pumping chambers of the heart.

"Despite dramatically improved early operative success achieved over the past 20 years, morbidity and mortality are still a challenge for children who have undergone a Fontan operation," said David J. Goldberg, M.D., pediatric cardiologist at The Children's Hospital of Philadelphia and primary investigator of this study. "The staged palliation does not recreate a normal two-ventricle circulation, instead the series of surgeries creates a unique physiology in which exercise capacity is dramatically diminished."

In this study, researchers randomized 28 children and young adults who had undergone the Fontan operation an average of 11 years earlier to receive either placebo or sildenafil three times a day for six weeks. After a six week break from treatment, subjects were switched to the opposite treatment course. As a "proof-of-concept" study, the researchers selected a relatively healthy cohort of subjects without significant complications that they felt would have sufficient exercise capacity to complete the study.

The researchers found significant improvements in exercise performance during treatment with sildenafil compared to placebo. The findings included improved ventilatory efficiency and, in two subgroups of patients, an improved ability to perform moderate levels of exercise. These changes suggest an overall improvement in the physiology associated with this unique circulation.

"The enhanced exercise performance that we found in the study is exciting and may lead to an improvement in day to day activities for these children and young adults," Goldberg said. "However, it is important to note that while the results of this study are encouraging, more work is needed to determine whether the short-term benefit found in this study holds up over a longer period of time and whether there are any long-term side effects."

"If the results from this preliminary study are validated in a larger sample over a longer period of time, it may be that this medication has the potential to improve quality of life for patients born with only one ventricle," Goldberg concluded.

For more information: www.chop.edu

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init