Ivabradine for Dysautonomia
(ADAPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Dysautonomia of Adolescence (dysautonomia) is an umbrella term used to describe symptoms experienced by adolescents and young adults related to dysfunction of the autonomic nervous system. Symptoms can include dizziness, fatigue, increased heart rate upon standing, exercise intolerance, and difficulty with daily activities. Treatment commonly involves lifestyle modifications, including increased fluid and salt intake and structured routines related to diet, sleep, aerobic exercise, and lower-body strength training. While these approaches can be effective, some patients experience symptoms that make it difficult to implement these changes.
Despite increasing awareness of dysautonomia, research evaluating effective treatment strategies in adolescents remains limited, and there are currently no medications approved by Health Canada specifically for the treatment of dysautonomia. Ivabradine is a heart rate-lowering medication approved for the treatment of heart failure and has been studied as a potential treatment for symptoms associated with dysautonomia, including postural orthostatic tachycardia syndrome (POTS). However, there is limited evidence regarding its use in adolescents.
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate whether ivabradine can reduce symptom burden and improve heart rate control and overall well-being in adolescents with dysautonomia. The study will use a series of N-of-1 randomized controlled trials in which participants receive both ivabradine and placebo during different treatment periods. This design will allow the effects of ivabradine and placebo to be compared within individual participants.
Are You a Good Fit for This Trial?
This trial is for adolescents and young adults who have symptoms of dysautonomia, such as dizziness, fatigue, or rapid heartbeat when standing. Participants should be able to follow the study procedures. People with certain medical conditions or on conflicting medications may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Ivabradine
Trial Overview
The study tests whether ivabradine, a medication that lowers heart rate, can help reduce symptoms of dysautonomia in adolescents compared to a placebo. Each participant will receive both treatments at different times in a randomized and blinded manner.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants randomized to this sequence receive placebo during the first treatment period, followed by a washout period, and then ivabradine during the second treatment period. Participants are independently re-randomized at the beginning of Cycle 2.
Participants randomized to this sequence receive ivabradine during the first treatment period, followed by a washout period, and then placebo during the second treatment period. Participants are independently re-randomized at the beginning of Cycle 2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kathryn Armstrong
Lead Sponsor
BC Children's Hospital Research Institute
Collaborator
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