Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03137537|
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : December 18, 2019
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:
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Autonomic Imbalance Cancer Survivorship||Drug: Ivabradine Drug: Placebo Oral Tablet||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.|
|Actual Study Start Date :||February 27, 2018|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2023|
lower heart rate in heart failure patients.
Other Name: Corlanor
Placebo Comparator: Placebo Oral Tablet
Drug: Placebo Oral Tablet
Procedure prescribed to compare the active effect of a medicine.
- To Investigate Whether Ivabradine Lowers Resting HR, Compared To Placebo, In Survivors Of Lymphoma [ Time Frame: 6 weeks ]Calculate the change in resting HR (from EKGs) from baseline to 6 weeks for each patient in the study (n=60).
- To Evaluate Whether Ivabradine Improves Exercise Duration, Compared To Placebo, In Survivors Of Lymphoma [ Time Frame: 6 weeks ]Calculate the change in exercise duration (from exercise treadmill stress tests) from baseline to 6 weeks for each patient in the study (n=60)
- To Evaluate Whether Ivabradine Improves Additional Markers of Cardiac Sympatho-vagal Balance, Compared To Placebo, In Survivors Of Lymphoma [ Time Frame: 6 weeks ]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)
- To Evaluate Whether Ivabradine Improves Health Related Quality Of Life Compared To Placebo, In Survivors Of Lymphoma [ Time Frame: 6 weeks ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137537
|Contact: Anju Nohria, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Tomas Neilan, MD 617-724-5351|
|Principal Investigator: Tomas Neilan, MD|
|Boston Children Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Ming Hui Chen, MD 617-355-8539|
|Principal Investigator: Ming Hui Chen, MD|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Anju Nohria, MD 617-525-7052 firstname.lastname@example.org|
|Principal Investigator: Anju Nohria, MD|
|Principal Investigator:||Anju Nohria, MD||Brigham and Women's Hospital|