Heart FailureINTERPRETNCT03160846
The Inotrope Evaluation and Research Patient Registry
An observational study of Heart Failure, run by Coram Clinical Trials at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Inotrope
- Type of treatment
- Injection or infusion
- How many people
- 129 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Aug 2014to 30 Sep 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Northwestern University, Bluhm Cardiovascular Institute
Chicago, Illinois, 60611
The University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center
New York, New York, 10032
About this study
Official title: Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Inotrope
- Keywords
- Inotrope, Milrinone, Dopamine, Dobutamine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InotropeDrug
Also called Primacor
Home intravenous infusion of Dobutamine, Dopamine, or Milrinone
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time of survival post-treatment
Recording length of time on treatment (in days) from start of care at Coram to study discharge date
Measured: Through study completion, on average 6 months
Number of re-hospitalizations
Recorded on the Pharmacy Clinical Progress Report
Measured: Through study completion, on average 6 months
Duration of re-hospitalizations
The duration (days) of re-hospitalization visits
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Monthly, through study completion (an average of 6 months)
Secondary outcomes (2)
Concomitant medication use
Patient medication profiles will be monitored for presence or absence of additional medications other than inotropes
Measured: Weekly, through study completion (an average of 6 months)
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
Measured: Weekly, through study completion (an average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start25 Aug 2014
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Coram Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Northwestern University, University of Kansas Medical Center, University of Alabama at Birmingham, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Erica Blanchard, PharmD, Study director, Coram/CVS specialty infusion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160846
- Sponsor's protocol ID
- CT-10-05
- Acronym
- INTERPRET
- Status last verified
- Dec 2020
- First submitted
- 16 May 2017
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program
- ClinicalTrials.gov ID
- NCT03160846
- Acronym / sponsor ID
- INTERPRET / CT-10-05
- Conditions
- Heart Failure
- Keywords
- Inotrope, Milrinone, Dopamine, Dobutamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Coram Clinical TrialsUniversity, hospital or other
- Collaborators
- Columbia University, Northwestern University, University of Kansas Medical Center, University of Alabama at Birmingham, Icahn School of Medicine at Mount Sinai
- Study start
- 25 Aug 2014 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InotropeAlso: PrimacorHome intravenous infusion of Dobutamine, Dopamine, or Milrinone | Drug | – |
Primary outcome
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
Number of re-hospitalizations
Time frame: Through study completion, on average 6 months
Recorded on the Pharmacy Clinical Progress Report
Duration of re-hospitalizations
Time frame: Through study completion, on average 6 months
The duration (days) of re-hospitalization visits
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
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
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)
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
2 secondary outcomes
Concomitant medication use
Time frame: Weekly, through study completion (an average of 6 months)
Additional patient symptoms
Time frame: Weekly, through study completion (an average of 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Results publicationCheckley 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Blanchard, PharmD study director
Coram/CVS specialty infusion
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Coram Clinical Trials at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time of survival post-treatment (time frame: Through study completion, on average 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.