A Phase 2 interventional study of Ivabradine and Placebo in Dysautonomia of Adolescence, sponsored by Kathryn Armstrong. Not yet recruiting at 1 site in Canada. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Kathryn Armstrong · Phase 2, Interventional, and Treatment
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.
Each N-of-1 trial will consist of two drug cycles of ivabradine/placebo or placebo/ivabradine with a 1-week washout period in between. Each participant will be randomized to treatment arms independently prior to the start of drug cycles 1 and 2 so that they may receive the treatments in either order during each drug cycle. Treatment overview:
Randomization cycle 1 a) Ivabradine - washout - Placebo or b) Placebo - washout - Ivabradine Cycle 1 washout Randomization cycle 2
a) Ivabradine - washout - Placebo or b) Placebo - washout - Ivabradine
This is the only study on the registry with Kathryn Armstrong as lead sponsor.
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Exclusion Criteria:
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.
Drug: Ivabradine · Drug: Placebo
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.
Drug: Ivabradine · Drug: Placebo
Participants will initially receive 2.5 mg of ivabradine orally twice daily with food. After 14 days of treatment, dosing will be reassessed. If there is insufficient symptom improvement, the Study Physician/Principal Investigator may increase the dose to 5 mg twice daily. Ivabradine will be prepared in 2.5 mg opaque capsules to maintain blinding.
Participants will receive matching placebo capsules orally twice daily with food. Placebo dosing will follow the same schedule as the ivabradine intervention, including a corresponding dose increase when required to maintain blinding. Placebo will be prepared in opaque capsules matching the ivabradine capsules.
Change from Baseline in Resting Heart Rate (bpm) at end of 4-week treatment period.
Heart rate will be measured (ECG testing) before and after each 4-week treatment period. A decrease of greater than or equal to 10 beats per minute after 4 weeks of drug treatment will be considered clinically significant.
Time frame: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Change from Baseline in Symptom Burden at end of 4-week treatment period.
Participants will identify 5 symptoms from a pre-defined list that are most disruptive to their day-to-day functioning. Individual symptoms will be rated for their frequency and severity using a 5-point Likert Scale from 0 = never or almost never have the symptom, to 4 = frequently have it, effect is severe. A decrease of 1 or more point on the Likert scale for 2 or more symptoms will be considered a meaningful response.
Time frame: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Change from Baseline in Quality of Life Score as assessed by the PedsQL 4.0 at end of 4-week treatment period.
Quality of Life Score will be assessed using the Pediatric Quality of Life Inventory (PedsQL 4.0) questionnaire. Scores are on a scale of 0-100, where higher scores indicate a higher quality of life. An increase of 5 or more points in QoL Score will be considered clinically meaningful.
Time frame: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Change from Baseline in Resting Heart Rate (bpm)
Participants will measure and self-report resting heart rate daily during each 4-week treatment period. Baseline measurements will be established for 1 week prior to start of the first drug cycle.
Time frame: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Change from Baseline in Resting Blood Pressure (mmHg)
Participants will measure and self-report resting blood pressure daily during each 4-week treatment period. Baseline measurements will be established for 1 week prior to start of the first drug cycle.
Time frame: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Plan to share: Yes — De-identified individual participant data collected during the study and underlying the results reported in publications may be made available to other researchers. Data will be shared in a manner that protects participant confidentiality and minimizes the risk of re-identification.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivabradine