N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

NCT ID: NCT00532688

Last Updated: 2007-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-02-29

Brief Summary

Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function.

Detailed Description

Ten patients will be invited to participate in the trial. After obtaining informed consent, the ten patients will be randomly assigned to one month of treatment with oral n-acetylcysteine 500mg or placebo twice daily for thirty days in addition to their regular therapy. At enrolment the patients will be educated and counselled about the trial and the intervention medication. Patients will also have a blood test (serum creatinine) that will allow the calculation of their renal function by use of the Cockroft Gault equation. Blood samples will also be frozen and stored. Patients will also undergo an ultrasound test of the function of their arm blood vessels. Both the blood test and the ultrasound test will be repeated at the completion of the thirty day trial period. Again the blood test sample will be frozen and stored. Subjects will then cross over to the other treatment arm for a further one month period, with the same testing at the end.

Conditions

Heart Failure, Congestive; Kidney Failure, Chronic

Keywords

acetylcysteine; N-acetylcysteine; heart failure; renal failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

5 patients: 28 days of n-acetylcysteine (in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period.

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

28 days of oral n-acetylcysteine (500mg bd)(in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.

2

28 days of oral distilled water (5ml) (in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to intervention (N-acetylcysteine 500mg oral bd) for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.

Group Type: PLACEBO_COMPARATOR

N-acetylcysteine

Intervention Type: DRUG

28 days of oral n-acetylcysteine (500mg bd)(in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.

Interventions

N-acetylcysteine

28 days of oral n-acetylcysteine (500mg bd)(in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.

Intervention Type: DRUG

Other Intervention Names

Mucomyst(R)

Eligibility Criteria

Inclusion Criteria

• Age 18 to 75 years inclusive;
• Patients with chronic heart failure NYHA II, III and IV and LVEF<40%. Stable medications for 1 month. Not admitted to hospital in the past month.
• Chronic renal failure with GFR (as estimated by the Cockroft Gault equation) of >30 ml/min and <50 ml/min not on any form of dialysis.

Exclusion Criteria

• Age <18 and >75 years;
• Myocardial infarction in the preceding six months;
• Acute decompensation of renal function or heart failure in the last 30 days;
• Allergy to n-acetylcysteine or glyceryl trinitrate;
• Contraindications to the use of glyceryl trinitrate as per the product information lodged with the PBS (Australia);
• On treatment with allopurinol, vitamin C or vitamin E or other antioxidant therapy at time of randomisation (statins are acceptable);
• Acute decompensation of another organ system in the last 30 days;
• Current pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: collaborator

Bayside Health

OTHER_GOV

Sponsor Role: lead

Principal Investigators

David Kaye, PhD FRACP

Role: PRINCIPAL_INVESTIGATOR

Alfred Heart Centre

Anthony Camuglia, MBBS

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Catherine Farrrington

Role: PRINCIPAL_INVESTIGATOR

Alfred Heart Centre

Jenny Starr

Role: PRINCIPAL_INVESTIGATOR

Alfred Heart Centre

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

David Kaye, PhD FRACP

Role: CONTACT

Phone: 610390762000

Email: david.kaye@baker.edu.au

Anthony Camuglia, MBBS(Hons)

Role: CONTACT

Phone: 610390762000

Email: anthonycamuglia@gmail.com

Facility Contacts

Anthony Camuglia, MBBS(Hons)

Role: primary

References

Camuglia AC, Maeder MT, Starr J, Farrington C, Kaye DM. Impact of N-acetylcysteine on endothelial function, B-type natriuretic peptide and renal function in patients with the cardiorenal syndrome: a pilot cross over randomised controlled trial. Heart Lung Circ. 2013 Apr;22(4):256-9. doi: 10.1016/j.hlc.2012.10.012. Epub 2012 Dec 7.

Reference Type: DERIVED

PMID: 23219310 (View on PubMed)

Other Identifiers

132/07

Identifier Type: -

Identifier Source: org_study_id