Acute Effects of Inhaled Treprostinil in Fontan Patients
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/11/2018 |
| Start Date: | February 21, 2017 |
| End Date: | September 21, 2018 |
A Randomized, Placebo-Controlled Pilot Study to Determine the Acute Effects of Inhaled Treprostinil on Exercise, Vascular Function, and Exercise Induced Liver Stiffness in Fontan Patients
In this pilot study investigators propose to explore the effects of a locally delivered
inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood
flow, venous pressure response and vascular function in stable Fontan patients. Investigators
will also assess the effects of resting and acute rises in exercise induced systemic venous
pressure on liver stiffness and will also assess whether treprostinil will attenuate the
acute stiffness increase that investigators expect to see. This will be a prospective,
randomized, double-blinded placebo controlled, crossover trial. Following recruitment and
informed consent, each participant will undergo three study visits, including baseline
testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and
visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.
inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood
flow, venous pressure response and vascular function in stable Fontan patients. Investigators
will also assess the effects of resting and acute rises in exercise induced systemic venous
pressure on liver stiffness and will also assess whether treprostinil will attenuate the
acute stiffness increase that investigators expect to see. This will be a prospective,
randomized, double-blinded placebo controlled, crossover trial. Following recruitment and
informed consent, each participant will undergo three study visits, including baseline
testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and
visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.
Inclusion Criteria:
1. Patients age 18 years and older
2. Single ventricle patients status post Fontan procedure
Exclusion Criteria:
1. Clinically unstable: these are patients who are experiencing new cardiovascular
symptoms such as worsening shortness of breath, new onset arrhythmia, uncontrolled
heart failure, or evidence of clinically significant cirrhosis or renal failure.
2. Evidence of Fontan pathway or intra cardiac obstruction as identified on prior
clinically indicated imaging studies (echocardiography and MRI);
3. Evidence of left or right systemic ventricular systolic dysfunction with an Ejection
fraction of <40% on either echocardiogram or MRI from previously documented clinical
data;
4. Presence of uncontrolled arrhythmias;
5. Unable to perform exercise testing for any reason or if deemed by the PI or designee
that exercise testing would not be in the best interest of the participant
6. Currently pregnant and/or breastfeeding
7. Patient unable to provide informed consent
8. BMI > 30 mg/m2
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Phone: 513-803-4244
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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