Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Columbia University | OTHER |
| Northwestern University | OTHER |
| University of Kansas Medical Center | OTHER |
| University of Alabama at Birmingham |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inotrope | Drug | Home intravenous infusion of Dobutamine, Dopamine, or Milrinone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Additional patient symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erica Blanchard, PharmD | Coram/CVS specialty infusion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Northwestern University, Bluhm Cardiovascular Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020105 | Milrinone |
| ID | Term |
|---|---|
| D000676 | Amrinone |
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 |
Not provided
Not provided
| OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
Not provided
Not provided
Not provided
| 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) |
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) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| The University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center | New York | New York | 10032 | United States |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |