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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01956006




Registration number
NCT01956006
Ethics application status
Date submitted
25/09/2013
Date registered
8/10/2013
Date last updated
11/01/2019

Titles & IDs
Public title
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Scientific title
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Secondary ID [1] 0 0
DK-MIL-2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Milrinone

Experimental: MIlrinone - ER milrinone


Treatment: Drugs: Milrinone
Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
NYHA Class
Timepoint [1] 0 0
3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/05/2018
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01956006
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01956006