Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nervous System Diseases

Rare Diseases

Lymphoma

Autonomic Nervous System Diseases

Primary Dysautonomias

Lymphosarcoma

* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination

* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination

lower heart rate in heart failure patients.

Ivabradine

Procedure prescribed to compare the active effect of a medicine.

Placebo Oral Tablet

Anju Nohria, MD

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

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

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

Calculate the change in cardiac autonomic function (from cardiac autonomic function testing) from baseline to 6 weeks in one half of the patients in the study (n=30)

Calculate the change in health related quality of life (from SF-36 quality of life surveys) from baseline to 6 weeks for each patient in the study (n=60)

Calculate the change in resting HR (from Holter monitor data) from baseline to 6 weeks for each patient in the study. Then compare the median change with ivabradine to the median change with placebo.

Calculate the change in exercise duration (from exercise treadmill stress tests) from baseline to 6 weeks for each patient in the study. Then compare the median change in exercise duration with ivabradine to the median change in exercise duration with placebo.

Amgen

Dana-Farber Cancer Institute

Assistant Professor in Internal Medicine

* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination

Ivabradine: lower heart rate in heart failure patients.

* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination

Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Beta-blocker at baseline

Baseline echo data not available in 2 pts randomized to the ivabradine group

Ejection Fraction, %

Resting heart rate

Dr. Anju Nohria

Analyzed all patients who had data available at baseline and at 6 weeks

Spots Global Cancer Trial Database for abnormal resting heart rate