Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Milrinone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Advanced HF (current inpatients) with no further clinical options as defined by treating cardiologist.
- NYHA III-IV
- LVEF<35%
- Recurrent hospitalization (>/=3 admissions in the preceding 12 months) for HF
- On optimal tolerated medical/device therapy. Stable therapy for 48hrs.
- Age 18-85 yrs
- Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
Exclusion Criteria:
- Hypotension (BPsys<85)
- Unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate >100).
- Severe renal impairment Cr>250umol/L or dialysis.
- Other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease.
- Pregnancy or female with childbearing potential and inability to use contraception
Sites / Locations
- Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MIlrinone
Arm Description
ER milrinone
Outcomes
Primary Outcome Measures
Safety and tolerability
Number of MACE events change from basline safety profile bloods (Full Blood Count, urea and creatine, Liver function counts) Change in haemodynamic measurements ECG and Blood pressure and HR Monitoring Swan Ganz insertion for haemodynamic measurements (RA volume , RVSP, CO, PA, PAWP)
Secondary Outcome Measures
NYHA Class
Change in Heart Failure Status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01956006
Brief Title
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Official Title
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
May 10, 2017 (Actual)
Study Completion Date
May 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Alfred
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening cardiovascular disorder, characterised by marked symptomatic limitation and frequent hospitalization. It is particularly prevalent in older individuals (up to 10% of the population) and it has become the most common cause for hospitalization in people >65yrs. As such it is also one of the leading consumers of healthcare spending. Recurrent hospitalization is frequently due in significant part to the lack of viable therapeutic options for severe HF. During hospital admission, medications through a drip to give through a vein (intravenous therapy), is required to improve heart pumping capacity (such as milrinone).They are frequently used and in many cases prolonged treatment periods of intravenous therapy are required. In a growing number of cases, there is a need to continue this treatment at home, however this is particularly costly and often complicated by intravenous line infection. As such there is an expanding need for therapeutic options in patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid release form of oral milrinone were examined, however these studies demonstrated adverse effects due to its quick release.
This study aims to determine the safety and tolerability of slow release oral milrinone in advanced HF patients with no further clinical option and to evaluate its effects on HF status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MIlrinone
Arm Type
Experimental
Arm Description
ER milrinone
Intervention Type
Drug
Intervention Name(s)
Milrinone
Intervention Description
Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Number of MACE events change from basline safety profile bloods (Full Blood Count, urea and creatine, Liver function counts) Change in haemodynamic measurements ECG and Blood pressure and HR Monitoring Swan Ganz insertion for haemodynamic measurements (RA volume , RVSP, CO, PA, PAWP)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
NYHA Class
Description
Change in Heart Failure Status
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
6 minute walk test
Description
Change in exercise capacity
Time Frame
3 month
Title
BNP
Time Frame
3 month
Title
Number of Heart Failure Hospitalisation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced HF (current inpatients) with no further clinical options as defined by treating cardiologist.
NYHA III-IV
LVEF<35%
Recurrent hospitalization (>/=3 admissions in the preceding 12 months) for HF
On optimal tolerated medical/device therapy. Stable therapy for 48hrs.
Age 18-85 yrs
Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
Exclusion Criteria:
Hypotension (BPsys<85)
Unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate >100).
Severe renal impairment Cr>250umol/L or dialysis.
Other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease.
Pregnancy or female with childbearing potential and inability to use contraception
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
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