N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Alfred
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00532688
First received: September 19, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Bayside Health

Additional 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
Study First Received: September 19, 2007
Last Updated: September 19, 2007
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

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

ClinicalTrials.gov processed this record on October 21, 2014