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N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Bayside Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00532688
First Posted: September 20, 2007
Last Update Posted: September 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Alfred
Information provided by:
Bayside Health
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.

Resource links provided by NLM:


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
Experimental: 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.
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.
Other Name: Mucomyst(R)
Placebo Comparator: 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.
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.
Other Name: Mucomyst(R)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00532688     History of Changes
Other Study ID Numbers: 132/07
First Submitted: September 19, 2007
First Posted: September 20, 2007
Last Update Posted: September 20, 2007
Last Verified: September 2007

Keywords provided by Bayside Health:
acetylcysteine
N-acetylcysteine
heart failure
renal failure

Additional relevant MeSH terms:
Kidney Failure, Chronic
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes