Healthy Adult study: Ivabradine
Official title Ivabradine for Heart Rate Reduction During Exercise in Healthy Adults
ClinicalTrials.gov ID: NCT07717710
What this study is testing
What is Ivabradine (single oral dose)?
An investigational oral medication being studied for its effect on heart rate during exercise in healthy adults. Ivabradine is designed to selectively inhibit HCN4 channels in the heart, which reduces heart rate without changing contractility.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether ivabradine reduces heart rate during exercise and if a higher dose works better. It also aims to learn how heart rate affects exercise ability as people age.
- Who it's for
- Healthy adults of any age who can safely ride a stationary bike.
- What's involved
- Participants will visit the clinic three times, do a cycling exercise test each visit, and take ivabradine before the test at the second and third visits (low dose then high dose). Researchers will watch for side effects like slow heart rate, visual changes, or headache.
- Time commitment
- The study lasts for three visits, each with a cycling test and medication administration.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 79. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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
- 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 \ 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
- Use of verapamil or diltiazem, which are moderate CYP3A4 inhibitors and also lower heart rate, posing a risk of excessive bradycardia when combined with ivabradine
- Lactose intolerance, as ivabradine contains lactose
- Known allergy/hypersensitivity to ivabradine or to any ingredient in the formulation or component of the container
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.