The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)
Virginia Commonwealth University
Summary
End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, or elect a palliative approach, inotropes are frequently used to improve hemodynamics through an increase in cardiac output and reduction in filling pressures. While inotropes provide profound symptomatic relief, these benefits are accompanied by significant risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is, therefore, an urgent need to develop strategies to reduce the dose or duration of inotrope use in the management of patients with stage D of HF.
Description
Heart failure (HF) represents a leading cause of morbidity and mortality worldwide. Despite improvements in treatments and widespread efforts to implement guideline directed medical therapies, a growing population of patients with end-stage HF has limited treatment options to improve their quality and quantity of life. When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, intravenous (IV) drugs that directly stimulate increased cardiac output ("…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Primary diagnosis for the clinic visit is stage D heart failure being on chronic stable dose of inotrope therapy (dobutamine or milrinone for the previous 28 days) * Prior documentation of impaired left ventricular systolic function (ejection fraction \<50%) at most recent assessment by any imaging modality (within 12 months) * Stable dose of inotrope treatment without a recent hospitalization within the previous month * Age ≥21 years and willing/able to provide written informed consent * The patient is willing and able to comply with the protocol (i.e. self administrati…
Interventions
- DrugAnakinra
Anakinra 100 mg SC daily will be administered to sujects on chronic inotrope treatment who are not candidates for transplantation or left ventricular assist device (LVAD).
Location
- Virginia Commonwealth UniversityRichmond, Virginia