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

To Investigate Whether Ivabradine Lowers Resting HR, Compared To Placebo, In Survivors Of Lymphoma

To Evaluate Whether Ivabradine Improves Exercise Duration, Compared To Placebo, In Survivors Of Lymphoma

To Evaluate Whether Ivabradine Improves Additional Markers of Cardiac Sympatho-vagal Balance, Compared To Placebo, In Survivors Of Lymphoma

To Evaluate Whether Ivabradine Improves Health Related Quality Of Life Compared To Placebo, In Survivors Of Lymphoma

Overall Study

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Heart Failure

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until one month after the last chemotherapy session.

Patients will receive placebo just before anthracycline chemotherapy, one capsule per oral twice daily, until one month after the last chemotherapy session.

Placebo

Stephanie I Rizk, MD

Ludhmila A Hajjar, MD, PhD

Ludhmila A Hajar, MD, PhD

Anthracyclines are associated with cardiotoxic effects. Previous studies suggest that enalapril, and or carvedilol, protect against cardiovascular effects of these drugs.

Ivabradine selectively reduces heart rate through inhibition of the cardiac pace maker IF channel, thus prolonging the duration of spontaneous depolarization in the sinus node. Additionally, ivabradine might preserve myocardial perfusion without negative inotropic effect and probably maintain cardiac contractility despite the reduction of heart rate.

Ivabradine has been shown to improve outcome in patients with heart failure and angina. The aim of this study is to evaluate whether ivabradine might prevent anthracycline-induced cardiotoxicity.

Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Randomized Clinical Trial

Composite endpoint of mortality or major cardiovascular outcomes (defined as acute myocardial infarction, heart failure, inappropriate sinus tachycardia and arrhythmia)

Incidence of left ventricular (LV) dysfunction defined as reduction of LV

Levels of NT-proBNP and high-sensitivity cardiac troponin T

Assessment by echocardiography the incidence of diastolic dysfunction using the following parameters: peak E-wave velocity, peak A-wave velocity, mitral valve (MV) E/A ratio, MV deceleration time, pulsed-wave tissue doppler imaging e' velocity, Mitral E/e', left atrium maximum volume index, pulmonary vein(PV) systole(S) wave, PV diastole (D) wave, continuous wave (CW) doppler: tricuspid regurgitation, systolic jet velocity; Color M- mode.

bradycardia, hypertension, atrial fibrillation, luminous phenomena, syncope, hypotension, erythema, rash, diplopia, vertigo, urticaria

Assessment of heart variability through 24-hour holter the following parameters: mRR - ms, SDNN - ms, SDANN - ms, SDNNi - ms, rMSSD-ms, NN50, pNN50.

Measurement of VO2 by cardiopulmonary exercise test

Measurement of ventilatory equivalents for oxygen (VE/VO2) and for carbon dioxide (VE/VCO2) by cardiopulmonary exercise test

LV diastolic diameter, LV diastolic diameter, LV diastolic diameter

LV mass, Septal thickness, Posterior wall thickness

Reduction in global longitudinal strain of at least 10% (GLS)

Incidence of left ventricular (LV) dysfunction defined as reduction of LV ejection fraction by 10%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.	NCT03137537	Lymphoma Autonomic Imbal... Cancer Survivor...	Ivabradine Placebo Oral Ta...	18 Years - 80 Years	Dana-Farber Cancer Institute
Ivabradine to Prevent Anthracycline-induced Cardiotoxicity	NCT03650205	Neoplasms Heart Failure Cardiotoxicity Chemotherapy Ef... Oncology	Ivabradine Placebo	18 Years - 85 Years	University of Sao Paulo

Spots Global Cancer Trial Database for ivabradine

Every month we try and update this database with for ivabradine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ivabradine

Every month we try and update this database with for ivabradine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ivabradine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.