Study: NCT06305780

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVIG + Coordinated Care
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVIG Placebo + Coordinated Care
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ivabradine + Coordinated Care
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ivabradine Placebo + Coordinated Care
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVIG + Usual Care
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVIG Placebo + Usual Care
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ivabradine + Usual Care
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ivabradine Placebo + Usual Care
Description: 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.