Advocate Children’s Hospital is the first site in Illinois to join a clinical trial testing an investigational nasal spray to treat children and adolescents with a specific type of tachycardia, or faster-than-normal heartbeat.
The study aims to determine the safety, efficacy, tolerability and proper dosing of an investigational drug called etripamil, which is designed to restore a normal heart rate in pediatric participants between the ages of 6 and 17 who come to the hospital having an episode of paroxysmal supraventricular tachycardia (PSVT).
“PSVT is a relatively common type of arrythmia, or irregular heartbeat, during which the heart beats too fast but still with a consistent rhythm,” said pediatric cardiologist and electrophysiologist Frank Zimmerman, MD, Advocate Aurora Research Institute’s principal investigator for the study. “PSVT can come and go very suddenly and can last anywhere from a few minutes to a few hours.”
A normal heart rate for children and adolescents in this age range is between 60 and 100 beats per minute. For patients with PSVT, heart rates climb over 100 beats per minute and sometimes much higher. When having a PSVT episode, people may also experience anxiety and confusion, chest pain, shortness of breath, dizziness, fatigue, and nausea.
“PSVT is not typically dangerous or life-threatening, but it can weaken the heart muscle over time and can sometimes lead to loss of consciousness,” Dr. Zimmerman said.
PSVT does not always require treatment, but patients who present to the hospital with an episode of PSVT are often treated with intravenous medications to restore a normal heart rate.
“Most of the traditional medications to treat PSVT are given through an IV, which is not always ideal when dealing with pediatric patients,” said Cheryl Lefaiver, PhD, RN, Director of the Center for Child and Family Research at the Research Institute. “So researchers are looking for alternatives ways, such as a nasal spray, to deliver PSVT treatment medications for kids who cannot receive an IV, are afraid of needles or may need treatment in addition to existing IV drugs.”
Researchers plan to enroll approximately 60 participants in the study, 30 between the ages of 6 and 11 and 30 between the ages of 12 and 17.
The clinical trial, “The NODE-202 study (study of etripamil nasal spray in pediatric patients),” is sponsored by Milestone Pharmaceuticals Inc., manufacturer of etripamil.
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