- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01956006
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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-
Victoria
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Melbourne, Victoria, Australien, 3004
- Alfred Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: MIlrinone
ER milrinone
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Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety and tolerability
Tidsramme: 3 months
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
NYHA Class
Tidsramme: 3 months
|
Change in Heart Failure Status
|
3 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
6 minute walk test
Tidsramme: 3 month
|
Change in exercise capacity
|
3 month
|
BNP
Tidsramme: 3 month
|
3 month
|
|
Number of Heart Failure Hospitalisation
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DK-MIL-2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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-
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