Ivabradine for Heart Rate Reduction During Exercise in Healthy Adults
Heart Rate Reduction Via Oral Ivabradine During Exercise in Healthy Adults to Understand Heart Rate/Work-rate Relations: A Pilot Dose-selection Study
1 other identifier
interventional
20
1 country
1
Brief Summary
During exercise, working muscles require more oxygen. The heart meets this demand in two ways: by beating faster (heart rate) and by pumping more blood with each beat (stroke volume). Heart rate increases steadily with exercise intensity until exhaustion, but the amount of blood pumped with each beat tends to plateau at moderate intensities. Why the amount of blood pumped with each beat becomes limited before heart rate, however, is not well understood. Studying these mechanisms is difficult because most drugs that lower heart rate also affect how strongly the heart pumps, making it hard to separate the two effects. One medication that can help with this is ivabradine, which is used to treat people with heart disease who have high resting heart rates. It slows the heart rate without changing how strongly the heart pumps. This study will investigate whether ivabradine lowers heart rate during exercise in healthy younger and older adults, and whether a higher dose lowers heart rate more. The results will help us better understand how heart rate influences the heart's ability to supply oxygen to the body during exercise, and what limits the ability to exercise as people age. Participants will:
- Attend three visits at SportsCardiologyBC in Vancouver
- Complete a cycling exercise test at each visit to measure heart rate and how hard they can exercise
- Take ivabradine (a heart-rate-lowering medication) before the exercise test at Visits 2 and 3 (a lower dose at Visit 2 and a higher dose at Visit 3)
- Be monitored for side effects including slow heart rate, visual symptoms, and headache.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Aug 2026
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2026
CompletedFirst Posted
Study publicly available on registry
July 21, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 22, 2026
July 1, 2026
4 months
July 10, 2026
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart rate, peak
Highest heart rate achieved during the cardiopulmonary exercise test.
Within 30 minutes of exercise onset
Secondary Outcomes (5)
Heart rate, resting
Within 15 minutes prior to exercise onset
Heart rate/work rate
Within 30 minutes of exercise onset
Incidence of visual symptoms
Within 4 hours post-dose administration
Incidence of headache
Within 4 hours post-dose administration
Incidence of bradycardia
Within 4 hours post-dose administration
Study Arms (1)
Ivabradine
EXPERIMENTALAll participants receive two single oral doses of ivabradine in a fixed sequence across separate experimental visits.
Interventions
A single oral dose of ivabradine is administered at each experimental visit, in a fixed order: 7.5 mg at Visit 2 (one 7.5 mg tablet), and 12.5 mg at Visit 3 (one 7.5 mg + one 5 mg tablet). Ivabradine is a selective hyperpolarization-activated cyclic nucleotide-gated transmembrane (HCN4) channel inhibitor that reduces heart rate without affecting myocardial contractility.
Eligibility Criteria
You may qualify if:
- Healthy males and females aged 19-39 years, and 60-79 years
- Engaging in regular aerobic exercise (e.g., running, cycling, swimming, hiking, field, ice, or racquet sports) at least once per week
You may not qualify if:
- History of any cardiovascular condition, including hypertension
- Use of any chronic medication
- History of any respiratory condition, including asthma
- Smoking, including cannabis or vaping in the past year
- History of diabetes mellitus, cancer, hepatic, renal or any other chronic illness
- Seated blood pressure ≥130/90 or \<100/60 mmHg
- Body mass index \<20 or \>32 kg/m2
- Non-sinus rhythm or abnormalities on 12-lead electrocardiogram (ECG)
- Pregnant, breastfeeding, or women of childbearing potential not using appropriate contraception
- Current or recent (past year) participation in \>150 minutes per week of moderate-vigorous intensity exercise (to avoid endurance training-related bradycardia)
- Any condition that prevents vigorous exercise from being performed safely
- Seated resting heart rate \<60 beats per minute
- Prolonged QT interval (e.g., long QT syndrome)
- Sick sinus syndrome, sino-atrial block or third-degree atrio-ventricular block
- Use of strong cytochrome P450 (CYP3A4) inhibitors (e.g., nirmatrelvir and ritonavir, ketoconazole), which can increase ivabradine levels in the blood to potentially unsafe levels
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SportsCardiologyBC, UBC Hospital
Vancouver, British Columbia, V6T 2B5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor, Department of Medicine
Study Record Dates
First Submitted
July 10, 2026
First Posted
July 21, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share