RECRUITING

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)

Quick Facts

Study Start:2024-02-05
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06062966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Prior documentation of impaired left ventricular systolic function (ejection fraction \<50%) at most recent assessment by any imaging modality (within 12 months)
  3. * Stable dose of inotrope treatment without a recent hospitalization within the previous month
  4. * Age ≥21 years and willing/able to provide written informed consent
  5. * The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
  6. * Screening plasma C-reactive protein levels \>2 mg/L
  1. * Concomitant clinically significant comorbidities including (but not limited to) acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration that would interfere with the execution, interpretation, or completion of the study
  2. * Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries
  3. * Previous or planned implantation of left ventricular assist devices or heart transplant within the next 3 months
  4. * Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs)
  5. * Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
  6. * Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA
  7. * Prior (within the past 5 years) or current malignancy on targeted treatment - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer
  8. * Stage V kidney disease or on renal-replacement therapy
  9. * Neutropenia (\<1,500/mm3 or \<1,000/mm3 in African-American patients)
  10. * Pregnancy or breastfeeding
  11. * Angina, hypertension, arrhythmias, electrocardiograph (ECG) changes, or other non-cardiac limitations that limit 6MWD obtained during the baseline testing
  12. * Hypersensitivity to anakinra or to E. coli derived products

Contacts and Locations

Study Contact

Benjamin VanTassell
CONTACT
8048284583
bvantassell@vcu.edu

Principal Investigator

Azita Talasaz
PRINCIPAL_INVESTIGATOR
Virginia Coomonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Azita Talasaz, PRINCIPAL_INVESTIGATOR, Virginia Coomonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-02-05
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Inotrope sensitivity
  • IL-1 Blockade
  • Subcutaneous (SC)
  • Hepatitis B Virus (HBV)
  • Hepatitis C Virus (HCV
  • 6 Minute Walk Test (6MWT)

Additional Relevant MeSH Terms

  • Heart Failure