N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure - Full Text View

Sponsors and Collaborators:	Bayside Health The Alfred
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00532688

Purpose

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

Condition	Intervention	Phase
Heart Failure, Congestive Kidney Failure, Chronic	Drug: N-acetylcysteine	Phase II Phase III

MedlinePlus related topics: Heart Failure Kidney Failure

Drug Information available for: Acetylcysteine Creatinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.

Further study details as provided by Bayside Health:

Primary Outcome Measures:

Vascular function via non invasive ultrasound measured flow mediated dilatation [ Time Frame: baseline, 4 weeks and 9 weeks ]
Estimated glomerular filtration rate calculated with Cockroft Gault equation. [ Time Frame: baseline, 4 weeks, 9 weeks ]

Secondary Outcome Measures:

Symptoms of heart failure [ Time Frame: baseline, 4 weeks, 9 weeks ]
Death [ Time Frame: baseline, 4 weeks, 9 weeks ]
Serum BNP (brain natriuretic peptide) [ Time Frame: baseline, 4 weeks, 9 weeks ]

Estimated Enrollment:	10
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2008

Arms	Assigned Interventions
1: Experimental 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.	Drug: 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.
2: Placebo Comparator 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.	Drug: 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.

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532688

Contacts

Contact: David Kaye, PhD FRACP	610390762000	david.kaye@baker.edu.au
Contact: Anthony Camuglia, MBBS(Hons)	610390762000	anthonycamuglia@gmail.com

Locations

Australia, Victoria
Alfred Hospital	Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Anthony Camuglia, MBBS(Hons) 90762000 anthonycamuglia@gmail.com
Principal Investigator: David Kaye, PhD, FRACP
Sub-Investigator: Anthony Camuglia, MBBS(Hons)
Sub-Investigator: Catherine Farrington
Sub-Investigator: Jenny Starr

Sponsors and Collaborators

Bayside Health

The Alfred

Investigators

Principal Investigator:	David Kaye, PhD FRACP	Alfred Heart Centre
Principal Investigator:	Anthony Camuglia, MBBS	The Alfred
Principal Investigator:	Catherine Farrrington	Alfred Heart Centre
Principal Investigator:	Jenny Starr	Alfred Heart Centre

More Information

Study ID Numbers:	132/07
Study First Received:	September 19, 2007
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00532688
Health Authority:	Australia: Therapeutic Goods Administration (TGA); Australia: National Health and Medical Research Council (NHMRC)

Keywords provided by Bayside Health:

acetylcysteine
N-acetylcysteine
heart failure
renal failure

Study placed in the following topic categories:

Renal Insufficiency
Heart Failure
Heart Diseases
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Acetylcysteine
Kidney Diseases
N-monoacetylcystine
Kidney Failure

Additional relevant MeSH terms:

Respiratory System Agents
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiviral Agents
Protective Agents

Pharmacologic Actions
Expectorants
Therapeutic Uses
Free Radical Scavengers
Cardiovascular Diseases
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009