The Inotrope Evaluation and Research Patient Registry

NCT03160846 | Completed

• 1 other identifier: CT-10-05
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure

Keywords

Inotrope; Milrinone; Dopamine; Dobutamine

Outcome Measures

Primary Outcomes (7)

• 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

• Number of re-hospitalizations

  Recorded on the Pharmacy Clinical Progress Report

  Through study completion, on average 6 months

• Duration of re-hospitalizations

  The duration (days) of re-hospitalization visits

  Through study completion, on average 6 months

• 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

• 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)

• 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)

• 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 Outcomes (2)

• Concomitant medication use

  Weekly, through study completion (an average of 6 months)

• Additional patient symptoms

  Weekly, through study completion (an average of 6 months)

Interventions

Inotrope DRUG

Home intravenous infusion of Dobutamine, Dopamine, or Milrinone

Also known as: Primacor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coram Clinical Trials: lead
• Columbia University: collaborator
• Northwestern University: collaborator
• University of Kansas Medical Center: collaborator
• University of Alabama at Birmingham: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Northwestern University, Bluhm Cardiovascular Institute

Chicago, Illinois, 60611, United States

Location

The University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center

New York, New York, 10032, United States

Location

Related 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/S0735-1097(18)31347-0

  RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Erica Blanchard, PharmD

  Coram/CVS specialty infusion

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 19, 2017
• Study Start: August 25, 2014
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: June 22, 2022

Record last verified: 2020-12

Locations

US (5)