Clinical trial NCT03160846: The Inotrope Evaluation and Research Patient Registry
Official title: Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Inotrope
Milrinone
Dopamine
Dobutamine
Lead sponsor: Coram Clinical Trials
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Northwestern University
name: University of Kansas Medical Center
name: University of Alabama at Birmingham
name: Icahn School of Medicine at Mount Sinai
First posted: 2017-05-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be identified by investigator and study staff from among patients admitted to hospital for HF that are being discharged to receive inotropic therapy in the home or infusion suite.

Brief summary: The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this registry will provide information on how a patient's quality of life and symptoms change over time while on inotrope therapy, and help healthcare providers to have a better understanding of the benefits and risks associated with bridge-to-treatment and palliative care.

Detailed description: Eligible patients will be consented by the site investigator or staff to participate in the Registry at the time of referral for home care. Clinical data, including dosing, symptom severity, lab values, and hospitalizations, along with data on quality-of-life and patient compliance with treatment, will be collected by the home care nurses and pharmacists. The Registry's goal is to significantly contribute to the medical understandings of heart failure treatment and to improve the quality of care for heart failure patients in the United States through active publication of registry findings and disease management approaches.

Eligibility criteria: Inclusion Criteria:

* Patient must be prescribed inotropic treatment (milrinone, dobutamine or dopamine)
* Patient must be referred to Coram for this treatment in an alternate site of care, either home or infusion suite
* Patient must be willing to receive care and comply with the teaching and training necessary to administer treatment
* Patient is age 18 or over

Exclusion Criteria:

* Patient is unable to start, or stops taking, inotropic medication
* Patient and/or patient insurance will not cover cost of home inotropic treatment with Coram, or patient elects not to start treatment
* Patient is under the age of 18

Primary outcomes:
measure: Mean time of survival post-treatment
timeFrame: Through study completion, on average 6 months
measure: Number of re-hospitalizations
timeFrame: Through study completion, on average 6 months
measure: Duration of re-hospitalizations
timeFrame: Through study completion, on average 6 months
measure: Primary cause of re-hospitalization visits
timeFrame: Through study completion, on average 6 months
measure: Implantable cardioverter defibrillator (ICD) activity
timeFrame: Weekly, through study completion (an average of 6 months)
measure: Patient reported symptom severity questionnaire
timeFrame: Monthly, through study completion (an average of 6 months)
measure: Quality of life assessment: Questionnaire
timeFrame: Monthly, through study completion (an average of 6 months)
Secondary outcomes:
measure: Concomitant medication use
timeFrame: Weekly, through study completion (an average of 6 months)
measure: Additional patient symptoms
timeFrame: Weekly, through study completion (an average of 6 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern University, Bluhm Cardiovascular Institute
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center Research Institute
state: Kansas
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center
state: New York
Study officials:
affiliation: Coram/CVS specialty infusion
name: Erica Blanchard, PharmD
role: STUDY_DIRECTOR
References:
citation: Checkley et. al. CONTINUOUS HOME INTRAVENOUS INOTROPIC THERAPY DECREASES SYMPTOM SEVERITY AND MAY REDUCE HOSPITALIZATIONS IN PATIENTS WITH ADVANCED HEART FAILURE Journal of the American College of Cardiology Mar 2018, 71 (11 Supplement) A806; DOI: 10.1016/S0735-1097(18)31347-0