Clinical trial NCT00532688: N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
Official title: Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Heart Failure, Congestive
Kidney Failure, Chronic
Keywords: acetylcysteine
N-acetylcysteine
heart failure
renal failure
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: The Alfred
First posted: 2007-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vascular function via non invasive ultrasound measured flow mediated dilatation
timeFrame: baseline, 4 weeks and 9 weeks
measure: Estimated glomerular filtration rate calculated with Cockroft Gault equation.
timeFrame: baseline, 4 weeks, 9 weeks
Secondary outcomes:
measure: Symptoms of heart failure
timeFrame: baseline, 4 weeks, 9 weeks
measure: Death
timeFrame: baseline, 4 weeks, 9 weeks
measure: Serum BNP (brain natriuretic peptide)
timeFrame: baseline, 4 weeks, 9 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Alfred Heart Centre
name: David Kaye, PhD FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: The Alfred
name: Anthony Camuglia, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred Heart Centre
name: Catherine Farrrington
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred Heart Centre
name: Jenny Starr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.