- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00532688
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
September 19, 2007 updated by: Bayside Health
Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.
Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David Kaye, PhD FRACP
- Phone Number: 610390762000
- Email: david.kaye@baker.edu.au
Study Contact Backup
- Name: Anthony Camuglia, MBBS(Hons)
- Phone Number: 610390762000
- Email: anthonycamuglia@gmail.com
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- Alfred Hospital
-
Contact:
- Anthony Camuglia, MBBS(Hons)
- Phone Number: 90762000
- Email: anthonycamuglia@gmail.com
-
Principal Investigator:
- David Kaye, PhD, FRACP
-
Sub-Investigator:
- Anthony Camuglia, MBBS(Hons)
-
Sub-Investigator:
- Catherine Farrington
-
Sub-Investigator:
- Jenny Starr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vascular function via non invasive ultrasound measured flow mediated dilatation
Time Frame: baseline, 4 weeks and 9 weeks
|
baseline, 4 weeks and 9 weeks
|
Estimated glomerular filtration rate calculated with Cockroft Gault equation.
Time Frame: baseline, 4 weeks, 9 weeks
|
baseline, 4 weeks, 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptoms of heart failure
Time Frame: baseline, 4 weeks, 9 weeks
|
baseline, 4 weeks, 9 weeks
|
Death
Time Frame: baseline, 4 weeks, 9 weeks
|
baseline, 4 weeks, 9 weeks
|
Serum BNP (brain natriuretic peptide)
Time Frame: baseline, 4 weeks, 9 weeks
|
baseline, 4 weeks, 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Study Completion (Anticipated)
February 1, 2008
Study Registration Dates
First Submitted
September 19, 2007
First Submitted That Met QC Criteria
September 19, 2007
First Posted (Estimate)
September 20, 2007
Study Record Updates
Last Update Posted (Estimate)
September 20, 2007
Last Update Submitted That Met QC Criteria
September 19, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency, Chronic
- Heart Failure
- Kidney Failure, Chronic
- Renal Insufficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 132/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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