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To determine the pharmacokinetic profile of a new (extended release) formulation of milrinone and to demonstrate evidence of hemodynamic effect
Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort) - to demonstrate evidence of haemodynamic benefit
Study Design: Open label
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milrinone 6mg | Experimental | single oral dose of 6mg ER milrinone tablet (Part A). 1. single intravenous infusion of milrinone (per Alfred Hospital protocol. 50ug/kg loading dose over 15 mins followed by infusion at 0.375 ug/kg/min for 6 hrs) - Part B. |
|
| Milrinone 10mg ER | Active Comparator | single oral dose of 10 mg ER milrinone tablet (Part A) single oral dose of 10 mg ER milrinone tablet (Part B) |
|
| Milrinone 14mg | Active Comparator | single oral dose of 14 mg ER milrinone tablet (Part A) single dose of 14 mg ER milrinone tablet 4. single oral dose of 18 mg ER milrinone tablet (if the group average plasma milrinone levels is less than 150 ug/L with 15 mg dose) - (Part B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milrinone 6mg | Drug | Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile - to demonstrate stable plasma levels | Laboratory Analysis: Plasma milrinone concentration | 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| (Heart Failure cohort) - to demonstrate evidence of haemodynamic benefit | ECG and Blood pressure and HR Monitoring Swan Ganz insertion for haemodynamic measurements (RA volume , RVSP, CO, PA, PAWP) | 6 hours |
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Inclusion Criteria:
Participants must:
Inclusion Criteria - Part B Heart Failure Patients
Participants must:
Exclusion Criteria:
Participants will not be enrolled if they meet any of the following criteria:
Exclusion Criteria - Part B Heart Failure Patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia | ||
| Nucleus Network |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020105 | Milrinone |
| ID | Term |
|---|---|
| D000676 | Amrinone |
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 |
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| milrinone 10mg ER | Drug | Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements |
|
|
| milrinone 14mg | Drug | Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements |
|
|
| Melbourne |
| Victoria |
| 3004 |
| Australia |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |