Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Bayside Health The Alfred |
---|---|
Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00532688 |
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 |
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. |
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.
|
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Kaye, PhD FRACP | 610390762000 | david.kaye@baker.edu.au |
Contact: Anthony Camuglia, MBBS(Hons) | 610390762000 | anthonycamuglia@gmail.com |
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 |
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 |
Study ID Numbers: | 132/07 |
Study First Received: | September 19, 2007 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00532688 History of Changes |
Health Authority: | Australia: Therapeutic Goods Administration (TGA); Australia: National Health and Medical Research Council (NHMRC) |
acetylcysteine N-acetylcysteine heart failure renal failure |
Heart Failure Renal Insufficiency Heart Diseases Antioxidants Kidney Failure, Chronic Antiviral Agents Urologic Diseases |
Renal Insufficiency, Chronic Expectorants Acetylcysteine Kidney Diseases N-monoacetylcystine Kidney Failure |
Anti-Infective Agents Respiratory System Agents Heart Failure Renal Insufficiency Antioxidants Heart Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Kidney Failure, Chronic Protective Agents Antiviral Agents Pharmacologic Actions |
Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Expectorants Free Radical Scavengers Acetylcysteine Cardiovascular Diseases Kidney Diseases N-monoacetylcystine Antidotes Kidney Failure |