NCT03137537

Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will explore whether ivabradine lowers heart rate, and thus improves exercise capacity, in survivors of lymphoma who have an elevated resting heart rate as a side effect of prior radiation treatment. The drugs involved in this study are: * Ivabradine * Placebo

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. This research study is a Pilot Study, which is the first time investigators are examining this study intervention for this particular problem. In this research study, the investigators are studying a drug called ivabradine. The investigators are exploring whether ivabradine can be used to reduce heart rate, increase exercise duration, and improve quality of life in survivors of lymphoma who received radiation to their chest as a part of their cancer treatment. The U.S. Food and Drug Administration (FDA) has not approved ivabradine for this specific disease, but it has approved the drug as an oral medication to lower heart rate in heart failure patients. Survivors of lymphoma who were treated with neck and/or chest radiation can have an elevated resting heart rate and an abnormal rate of decline in their heart rate after exercise, also known as cardiac autonomic dysfunction. These abnormalities can limit exercise duration and worsen quality of life in some radiation treated survivors of lymphoma

Conditions

• Lymphoma
• Autonomic Imbalance
• Cancer Survivorship

Interventions

Type	Name	Description
DRUG	Ivabradine	lower heart rate in heart failure patients.
DRUG	Placebo Oral Tablet	Procedure prescribed to compare the active effect of a medicine.

Timeline

• Start date: 2018-02-27
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2017-05-02
• Last updated: 2022-02-10
• Results posted: 2022-02-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study