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NCT Number: NCT03160846

The Inotrope Evaluation and Research Patient Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inotrope

Drug

Home intravenous infusion of Dobutamine, Dopamine, or Milrinone

Other names: Primacor

Primary outcomes

  1. Mean time of survival post-treatment

    Time frame: Through study completion, on average 6 months

    Recording length of time on treatment (in days) from start of care at Coram to study discharge date

  2. Number of re-hospitalizations

    Time frame: Through study completion, on average 6 months

    Recorded on the Pharmacy Clinical Progress Report

  3. Duration of re-hospitalizations

    Time frame: Through study completion, on average 6 months

    The duration (days) of re-hospitalization visits

  4. Primary cause of re-hospitalization visits

    Time frame: Through study completion, on average 6 months

    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

  5. Implantable cardioverter defibrillator (ICD) activity

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

    Number of ICD firings as recorded by nurse on patient clinical progress report

  6. Patient reported symptom severity questionnaire

    Time frame: Monthly, through study completion (an average of 6 months)

    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)

  7. Quality of life assessment: Questionnaire

    Time frame: Monthly, through study completion (an average of 6 months)

    The patient completed Kansas City Cardiomyopathy Questionnaire will be used to report the overall patient quality of life

Secondary outcomes

  1. Concomitant medication use

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

    Patient medication profiles will be monitored for presence or absence of additional medications other than inotropes

  2. Additional patient symptoms

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

    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

Sponsors and collaborators

Lead sponsor

Coram Clinical Trials

Other

Collaborators

  • Columbia University
  • Icahn School of Medicine at Mount Sinai
  • Northwestern University
  • University of Alabama at Birmingham
  • University of Kansas Medical Center

Registry information

Official study title

Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program

Acronym: INTERPRET

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
May 19, 2017
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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