Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure

NCT ID: NCT01956006

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2018-05-10

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIlrinone

ER milrinone

Group Type: EXPERIMENTAL

Milrinone

Intervention Type: DRUG

Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.

Interventions

Milrinone

Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: lead

Responsible Party

Prof David Kaye

Head, Experimental Cardiology and Heart Failure Division Baker Heart Research Institute & Cardiologist, Heart Centre, Alfred Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

DK-MIL-2

Identifier Type: -

Identifier Source: org_study_id