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Study of Etripamil Nasal Spray for Children with Paroxysmal Supraventricular Tachycardia (Ages 6-18)

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Paroxysmal Supraventricular Tachycardia (PSVT), which is a type of rapid heart rate that starts and stops suddenly. The treatment being tested is a medication called Etripamil, which is administered as a nasal spray. The purpose of the study is to evaluate how effective a single dose of this nasal spray is in stopping an episode of PSVT in children.

The study is divided into two parts based on age groups: one for patients aged 12 to under 18 years, and another for those aged 6 to under 12 years. During the study, participants will receive the Etripamil nasal spray to see if it can successfully convert the rapid heart rate back to a normal rhythm. The nasal spray is designed to deliver the medication directly through the nose using a special device that ensures the correct amount is administered.

Participants will be monitored to see how quickly the treatment works and whether any additional medical help is needed. The study will also look at how well the nasal spray is tolerated, including any side effects at the site where it is administered, and any changes in vital signs like heart rate and blood pressure after using the spray. The goal is to determine the safety and effectiveness of Etripamil nasal spray for treating PSVT in children.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that all necessary consent forms are signed. This includes providing written informed consent or assent, depending on age.
If applicable, a pregnancy test will be conducted for females of childbearing potential. Adequate contraception must be used throughout the study duration.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking the body mass index (BMI) and reviewing the medical history of paroxysmal supraventricular tachycardia (PSVT).
Documentation of PSVT through an electrocardiogram (ECG) or other monitoring methods is required.
Step 3
Receiving the medication
The medication used in this study is etripamil, administered as a nasal spray.
A single dose of the nasal spray will be given during a spontaneous episode of PSVT.
Step 4
Monitoring after administration
After receiving the nasal spray, monitoring will occur to observe the effects. The primary goal is to convert PSVT to a normal heart rhythm within 15 minutes.
Vital signs, such as heart rate and blood pressure, will be checked. Any side effects or reactions at the administration site will be recorded.
Step 5
Follow-up
A follow-up visit will be scheduled to assess the overall response to the treatment and to ensure no further medical intervention is needed.
During this visit, any additional questions or concerns can be addressed.

Who can join the trial?

9 criteria

Patients must be male or female.
For Part 1: Patients must be 12 to under 18 years old.
For Part 2: Patients must be 6 to under 12 years old.
Patients must have a body mass index (BMI) between the 5th and 85th percentiles for their age and sex. BMI is a measure of body fat based on height and weight.
Patients must have a history of paroxysmal supraventricular tachycardia (PSVT) documented by an ECG or other monitoring device. An ECG is a test that records the electrical activity of the heart.
If the patient had a prior ablation for PSVT, they must have documented evidence of PSVT after the procedure. Ablation is a treatment that uses heat or cold to destroy tissue in the heart that causes abnormal heart rhythms.
Patients must provide written informed consent or assent. This means they agree to participate in the study after being informed about it.
Females who can become pregnant must have a negative pregnancy test at screening and use adequate contraception unless they are completely abstinent. Contraception must be used from the time of consent until the follow-up visit. Acceptable methods include hormonal contraception, an intrauterine device (IUD), or barrier methods like condoms.
Patients must be willing and able to comply with study procedures.

Who cannot join the trial?

3 criteria

Patients who do not have Paroxysmal Supraventricular Tachycardia (PSVT) cannot participate. PSVT is a condition where the heart suddenly beats much faster than normal.
Patients who are not within the age range of 6 to less than 18 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like those with certain disabilities or conditions.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain

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Investigated drugs

Etripamil Nasal Spray is a medication used in this clinical trial to help stop episodes of a heart condition called paroxysmal supraventricular tachycardia (PSVT). PSVT is a condition where the heart suddenly beats much faster than normal. This medication is given as a spray into the nose, which allows it to work quickly. The goal of using this nasal spray is to help bring the heart rate back to normal during an episode of PSVT. The trial is testing how well this medication works and how safe it is for children aged 6 to 18 years old who experience these sudden fast heartbeats.

Etripamil

What is already known about the treatment

Etripamil – Etripamil is administered as a nasal spray, making it easy to use for patients experiencing episodes of paroxysmal supraventricular tachycardia (PSVT), a condition characterized by rapid heartbeats. Currently, it is being studied in clinical trials to assess its effectiveness and safety in children aged 6 to 18 years. The main therapeutic use of etripamil is to quickly stop episodes of PSVT. It works by blocking certain calcium channels in the heart, which helps to slow down the heart rate. Etripamil is classified as a calcium channel blocker in pharmacology.

Investigated diseases

Paroxysmal Supraventricular Tachycardia (PSVT) – Paroxysmal Supraventricular Tachycardia is a condition characterized by episodes of rapid heart rate that originate above the heart's ventricles. These episodes can start and stop suddenly and may last from a few seconds to several hours. During an episode, the heart can beat at a rate of 150 to 250 beats per minute. The condition occurs when electrical signals in the heart's upper chambers misfire, causing the heart to beat faster than normal. Symptoms can include palpitations, dizziness, shortness of breath, and chest discomfort. The episodes can vary in frequency and may be triggered by stress, caffeine, or alcohol.