Clinical trial NCT01956006: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Lead sponsor: The Alfred
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and tolerability
timeFrame: 3 months
Secondary outcomes:
measure: NYHA Class
timeFrame: 3 months
Other outcomes:
measure: 6 minute walk test
timeFrame: 3 month
measure: BNP
timeFrame: 3 month
measure: Number of Heart Failure Hospitalisation
timeFrame: 3 months
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
References: