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

Status: Terminated
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children Hospital
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Time Frame
Start Date: 2018-02-27
Completion Date: 2020-11-18
Participants
Target number of participants: 23
Treatments
Experimental: Ivabradine
* 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_comparator: Placebo Oral Tablet
* Placebo will be administered for a total of 6 weeks~* Placebo is taken orally twice daily~* Dosage will be adjusted according to physician determination
Authors
Ming Hui Chen, Tomas Neilan, Anju Nohria
Related Therapeutic Areas
Sponsors
Collaborators: Amgen
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov