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

NCT01956006 | Completed Phase 1

• 1 other identifier: DK-MIL-2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months

Secondary Outcomes (1)

• NYHA Class

  3 months

Other Outcomes (3)

• 6 minute walk test

  3 month

• BNP

  3 month

• Number of Heart Failure Hospitalisation

  3 months

Study Arms (1)

MIlrinone

EXPERIMENTAL

ER milrinone

Drug: Milrinone

Interventions

Milrinone DRUG

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

MIlrinone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Experimental Cardiology and Heart Failure Division Baker Heart Research Institute & Cardiologist, Heart Centre, Alfred Hospital

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)