The Inotrope Evaluation and Research Patient Registry

Heart Failure Clinical Trial

— INTERPRET  

Official title:

Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160846
• Other study ID #: CT-10-05
• Status: Completed
• Start date: August 25, 2014
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2020
• Source: Coram Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Inotrope
Home intravenous infusion of Dobutamine, Dopamine, or Milrinone

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University, Bluhm Cardiovascular Institute	Chicago	Illinois
United States	The University of Kansas Medical Center Research Institute	Kansas City	Kansas
United States	Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Coram Clinical Trials	Columbia University, Icahn School of Medicine at Mount Sinai, Northwestern University, University of Alabama at Birmingham, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean time of survival post-treatment	Recording length of time on treatment (in days) from start of care at Coram to study discharge date	Through study completion, on average 6 months
Primary	Number of re-hospitalizations	Recorded on the Pharmacy Clinical Progress Report	Through study completion, on average 6 months
Primary	Duration of re-hospitalizations	The duration (days) of re-hospitalization visits	Through study completion, on average 6 months
Primary	Primary cause of re-hospitalization visits	The primary cause of re-hospitalization visits following treatment will be recorded by nurse on patient clinical progress report from a drop-down list with the following options: Central venous access device malfunction, central venous access device infection, cognitive changes, fatigue, dyspnea, fever, chest pain, blood pressure instability, edema, weight gain, nausea and anorexia, and other	Through study completion, on average 6 months
Primary	Implantable cardioverter defibrillator (ICD) activity	Number of ICD firings as recorded by nurse on patient clinical progress report	Weekly, through study completion (an average of 6 months)
Primary	Patient reported symptom severity questionnaire	A patient completed questionnaire will be used to report the severity of the following symptoms: Pain, Fatigue, Edema, Shortness of breath (with exertion), Shortness of breath (without exertion)	Monthly, through study completion (an average of 6 months)
Primary	Quality of life assessment: Questionnaire	The patient completed Kansas City Cardiomyopathy Questionnaire will be used to report the overall patient quality of life	Monthly, through study completion (an average of 6 months)
Secondary	Concomitant medication use	Patient medication profiles will be monitored for presence or absence of additional medications other than inotropes	Weekly, through study completion (an average of 6 months)
Secondary	Additional patient symptoms	A weekly nurse completed clinical progress report will record the presence or absence of the following: increased urination at night, swollen abdomen, breathing problem when lying down to sleep, cough with frothy sputum, loss of appetite, depression, and confusion and/or memory challenges	Weekly, through study completion (an average of 6 months)