Clinical effects of N-acetylcysteine in the treatment of acute decompensated heart failure

Phase 2

Recruiting

• Conditions: Acute decompensated heart failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12611000766910
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Hospital admission with acute decompensated HF including congestion (or) hypotension (or) worsening renal function (or) other end organ dysfunction.
-NYHA Class III or IV
-LVEF < 40%

Exclusion Criteria

Age < 18, and >75
-LVAD or ECMO in situ or likely requirement for LVAD/ECMO within 24 hrs
-endotracheal intubation/ventilation
-cardiac or other solid organ transplantation
-STEMI at presentation
-Allergy to n-acetylcysteine
- pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the between group distribution of treatment success, treatment failure or no change in the patient?s clinical condition at Day 5. Treatment success = improvement in symptoms at D5. Treatment failure = death, readmission, worsening symptoms or signs of HF at D5, worsening renal function (= >27umol/L rise in creatinine).[Day 5 after hospital admission];The co-primary end-point is an improvement in forearm blood flow (measured by venous occlusion plethysmography and endoPAT).[Day 5 after hospital admission]

Secondary Outcome Measures

Name	Time	Method
Death[Day 30];Worsening renal function (= >27umol/L rise in creatinine)[Day 30];Re-hospitalization[Day 30];Worsening HF (KCCQ heart failure questionaire & blinded clinical assessment by the treating physician)[Day 30]