381
Participants
Start Date
March 11, 2024
Primary Completion Date
July 9, 2025
Study Completion Date
July 9, 2025
IVIG + Coordinated Care
Participants will receive IVIG for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator.
IVIG Placebo + Coordinated Care
"Normal saline given intravenously will be the control (placebo) product. Blinding IV bag and tubing covers will be used for both IVIG and Placebo administration.~Participants will receive IVIG placebo for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator."
Ivabradine + Coordinated Care
Participants will receive Ivabradine for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
Ivabradine Placebo + Coordinated Care
"The control (placebo) oral tablets will be similar to the study drug, ivabradine.~The control packaging matches the packaging.~Participants will receive Ivabradine placebo for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, feedback, nutrition counseling, motivation, education, and assisted care through care coordinator."
IVIG + Usual Care
Participants will receive IVIG for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG administration.
IVIG Placebo + Usual Care
"Normal saline given intravenously will be the control (placebo) product. The normal saline will be of similar formulation and appearance to IVIG.~Participants will receive IVIG placebo for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG placebo administration."
Ivabradine + Usual Care
Participants will receive Ivabradine for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine administration.
Ivabradine Placebo + Usual Care
"The control (placebo) oral tablets will be similar to the study drug, ivabradine.~The control packaging matches the packaging.~Participants will receive Ivabradine placebo for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine placebo administration."
Columbia University Irving Medical Center - Appendix A & B, New York
Montefiore Medical Center - Moses Campus - Appendix B, The Bronx
Stony Brook University Hospital - Appendix A & B, Stony Brook
St. Lawrence Health Medical Campus - Appendix A & B, Canton
University at Buffalo - Appendix A & B, Buffalo
MedStar National Rehabilitation Hospital - Appendix B only, Washington D.C.
Johns Hopkins Hospital - Appendix A Only, Baltimore
University of Virginia Health System, University Hospital - Appendix A & B, Charlottesville
Sentara Norfolk General Hospital - Appendix A & B, Norfolk
Marshall Health - University Physicians and Surgeons - Appendix A & B, Huntington
Duke University Hospital - Appendix A & B, Durham
East Carolina University - Appendix B Only, Greenville
Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B, Atlanta
Morehouse School of Medicine - Appendix A & B, Atlanta
University of Florida Health - Appendix A & B, Gainesville
Innovation Clinical Trials Inc.- Appendix A & B, Palmetto Bay
Lakeland Regional Medical Center - Appendix A & B, Lakeland
East Alabama Medical Center - Appendix B Only, Opelika
Vanderbilt University Medical Center, Nashville
University of Mississippi Medical Center - Appendix A & B, Jackson
University of Kentucky Medical Center - Appendix A & B, Lexington
Cleveland Clinic - Appendix A & B, Cleveland
Henry Ford Hospital - Appendix A & B, Detroit
University of Iowa - Appendix A & B, Iowa City
Mayo Clinic - Appendix A & B, Rochester
NorthShore University HealthSystem - Evanston Hospital - Appendix B Only, Evanston
Rush University Medical Center - Appendix B Only, Chicago
University of Illinois at Chicago - Appendix A & B, Chicago
Washington University School of Medicine - Appendix B Only, St Louis
University of Kansas Medical Center CTSU Fairway - Appendix A & B, Fairway
University Medical Center New Orleans - Appendix A & B, New Orleans
University of Arkansas for Medical Sciences - Appendix A & B, Little Rock
University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B, Oklahoma City
Southwest Family Medicine Associates - Appendix A & B, Dallas
University of Texas Health Science Center at San Antonio - Appendix A & B, San Antonio
University of Texas Health Science Center at Houston, Houston
National Neuromuscular Research Institute - Appendix A & B, Austin
University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B, Aurora
Bateman Horne Center - Appendix B Only, Salt Lake City
Center for Complex Neurology - Appendix A & B, Phoenix
Cedars Sinai Medical Center - Appendix A & B, Los Angeles
University of California San Diego - Appendix B Only, La Jolla
Stanford University - Appendix B Only, Stanford
Queens Medical Center - Appendix B Only, Honolulu
Oregon Health and Science University - Appendix A & B, Portland
Evergreen Hospital Medical Center - Appendix A & B, Kirkland
Providence Medical Research Center - Appendix A & B, Spokane
Brigham and Women's Hospital - Appendix A Only, Boston
Kent Hospital - Appendix A & B, Pawtucket
Vermont Lung Center, University of Vermont - Appendix B Only, Burlington
Kanecia Obie Zimmerman
OTHER