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NCT01956006
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Phase 1, PHASE2 trial testing Milrinone in Heart Failure in 26 participants. Completed in 10 May 2018.
10 May 2017
Quick facts
| Lead sponsor | The Alfred |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 October 2013 |
| Primary completion | 10 May 2017 |
| Estimated completion | 10 May 2018 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Milrinone (MILRINONE) — full drug profile →
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
The Alfred — full company profile →
Who can join
Adults 18 to 85, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01956006
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Milrinone
Trials testing the same drug.
- NCT06562036 — Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children · NA · completed
- NCT07186062 — Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure Wit · completed
- NCT05132153 — Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery · Phase 4 · unknown
- NCT03855579 — Levosimendan Versus Milrinone in Off Pump CABG Surgery · Phase 4 · unknown
- NCT02951130 — Milrinone in Congenital Diaphragmatic Hernia · Phase 2 · completed
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other The Alfred trials
Trials by the same sponsor.
- NCT07430267 — Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion · NA · not yet recruiting
- NCT05591677 — D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT) · Phase 2 · active not recruiting
- NCT04113993 — Bazedoxifene -Treatment for Women With Schizophrenia · Phase 4 · unknown
- NCT03095859 — Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation · NA · completed
- NCT03026985 — Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring ECMO · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01956006 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Alfred
- Last refreshed: 11 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01956006.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing