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UDCA in Chronic Heart Failure
NCT00285597Phase 2
Key facts
- Status
- Unknown
- Start
- May 2004
- Countries
- 1
- Sponsor
- National Heart and Lung Institute
- Modality
- Orthosteric Ligands
- Drugs
- ursodeoxycholic acid
- Conditions
- chronic heart failure (CHF)
01
Overview
Phase 2, randomised, double-blind trial of ursodeoxycholic acid in chronic heart failure (CHF) (2 arms), sponsored by National Heart and Lung Institute. Primary endpoint: Peripheral blood flow as assessed by venous occlusion plethysmography at 4 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
UDCA then Placebo
Patients receive UDCA in Period 1 and Placebo in Period 2
Placebo then UDCA
Patients receive Placebo in Period 1 and UDCA in Period 2
03
Who it enrols
Patients with stable chronic heart failure (NYHA II-IV), LVEF <= 40% or LVEDD >= 60mm, on stable medication for at least 1 month. Excludes severe renal/liver disease, recent cardiac events, and immunosuppressive therapy.
04
Endpoints
Primary
Peripheral blood flow as assessed by venous occlusion plethysmography
Secondary
Peak and resting arm and leg post-ischaemic blood flow
Tumor Necrosis Factor-alpha levels
Soluble CD14 levels
Soluble TNF-Receptor 1 levels
Lipopolysaccharide levels
Cellular immune function
Endothelin-1 plasma levels
B type natriuretic peptide levels
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