Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation … (NCT03137537) | Clinical Trial Compass
TerminatedPhase 2
Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy.
Stopped: Funding terminated
United States23 participantsStarted 2018-02-27
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Survivors of mediastinal lymphoma (either Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma) with no active malignancy
* Prior mediastinal or mantle radiation ≥ 5 years prior to enrollment in the study
* Age 18-80 years.
* Participants must have normal organ function as defined below:
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
* creatinine clearance ≥ 15 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
* Normal sinus rhythm with resting heart rate ≥ 80 bpm on screening EKG
* Based on findings in animals, ivabradine may cause fetal harm when administered to a pregnant woman. For this reason, women of child-bearing potential must agree to use adequate contraception.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Participants who are receiving any other investigational agents.
* History of allergic reaction to ivabradine.
* Participants receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 are ineligible.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, acute coronary syndrome, symptomatic known coronary artery disease, severe valvular heart disease, active malignancy, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because…
What they're measuring
1
To Investigate Whether Ivabradine Lowers Resting HR, Compared To Placebo, In Survivors Of Lymphoma