The Inotrope Evaluation and Research Patient Registry

NCT ID: NCT03160846

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-25

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Inotrope

Home intravenous infusion of Dobutamine, Dopamine, or Milrinone

Intervention Type DRUG

Other Intervention Names

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Primacor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Coram Clinical Trials

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erica Blanchard, PharmD

Role: STUDY_DIRECTOR

Coram/CVS specialty infusion

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Northwestern University, Bluhm Cardiovascular Institute

Chicago, Illinois, United States

Site Status

The University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

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

New York, New York, United States

Site Status

Countries

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United States

References

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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

Reference Type RESULT

Other Identifiers

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CT-10-05

Identifier Type: -

Identifier Source: org_study_id

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