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The effects of N-acetyl cysteine (NAC) in patients with heart failure

The effects of N-acetyl cysteine (NAC) in patients with heart failure: a double-blind, placebo-controlled, randomised cross-over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66348022
Enrollment
50
Registered
2005-09-30
Start date
2004-04-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure Circulatory System Heart failure

Interventions

We intend to conduct a double blind, placebo-controlled, randomised, cross-over trial comparing NAC (600 mg once daily [od], effervescent tablet Flumicil®) to placebo in patients with persistent major

Sponsors

Department of Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Blood samples will be taken to measure N-terminal pro-brain natriuretic peptide (NT-proBNP), tumour necrotising factor (TNF), interleukin-6 (IL-6), soluble tumour necrosis factor receptor 1 (sTNFR1), soluble tumour necrosis factor receptor 2 (sTNFR2). Oxidative stress will be assessed by the measurement of 8-epimer of Prostaglandin F2 (8-iso-PGF2). The effects on the myocardial interstitium will be assessed by measuring 3 degradation markers total membrane metalloproteinase 1 (MMP-1), total tissue inhibitor of metalloproteinase 1 (TIMP 1), and the MMP-1/TIMP 1 complex. As well as 3 extra-cellular matrix serum markers pro-collagen type I carboxy-terminal peptide (P-I-CP), pro-collagen type I amino terminal peptide (P-I-NP), and pro-collagen type III amino terminal peptide (P-III-NP). They will be collected by Dr Windram and members of the nursing staff of the Department of Academic Cardiology Department.

Exclusion criteria

Exclusion criteria: 1. Asthma 2. Known intolerance to NAC 3. Serum creatinine greater than 200 mol/L

Design outcomes

Primary

MeasureTime frame
Improvement in left ventricular ejection fraction (LVEF), measured by cine-magnetic resonance imaging.

Secondary

MeasureTime frame
1. Symptoms 2. Exercise capacity 3. Natriuretic peptides 4. Serum creatinine 5. Vascular function

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026