About the Trial
The Department of Emergency Medicine research team, under the direction of Dr. Jeffrey Kline is conducting the iNOPE trial to test the safety and effectiveness of inhaled nitric oxide (iNO). Inhaled NO has a very short half-life in blood and has a selective pulmonary vasodilation. Inhaled nitric oxide has been cleared by the US Food and Drug Administration (FDA) for treatment of pulmonary hypertension and hypoxemic respiratory failure in newborns but not for pulmonary embolism. We are conducting a phase II randomized trial to test iNO as a therapy to help reduce pressure on the heart that can occur with PEs. The selective vasodilation of the pulmonary vasculature allows more blood flow to the heart and helps relieve patients’ difficulty breathing. A previous study, conducted by Dr. Kline, demonstrated that iNO reduced difficulty breathing without adverse events in patients with severe submassive PE.
iNOPE is a multicenter study involving several academic hospitals including IU Health Methodist Hospital, IU Health University Hospital, Eskenazi Hospital, and the University of Mississippi Medical Center (UMMC). The goal is to enroll 86 subjects over the next three years. The research team includes basic science researchers, current research faculty and fellows, and a research staff.
How to Enroll
The research team is still currently looking to enroll PE patients. For enrollment, the patient needs to have signs or symptoms of right heart strain. This can be from the following:
- Positive Troponin
- CT Scan stating Right Heart Strain
- Formal ECHO with Right Heart Strain
You don’t have to have all of them, any single one will qualify the patient.
Please contact any member of the research team if you have questions. In addition we have listed the enrollment criteria at both Methodist and Eskenazi Emergency Departments.
Our subjects receive standard of care, but after consent and enrollment either receive iNO or placebo for 24 hours via nasal cannula. Subjects are then followed until their hospital discharge and through 28 days for adverse events and again at 3 months for a PEmb-QoL (quality of life) survey. Between all four sites we have successfully enrolled 24 subjects and have 100% follow-up rate.
This study has been truly rewarding for us as our enrolled patients are altruistic; wanting to be able to help patients like them in the future. We build relationships with these patients and their families and they know we care. Our research team is dedicated in helping others and feels that someday the research we are doing will make a difference. Thank you for all of you who have helped identify these patients.
The Research Team
Vice Chair, Research
Division Chief, Research
Editor in Chief, Academic Emergency Medicine