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
Recruitment status was Recruiting
Sponsor:
Bayside Health
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
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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
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 Heart Diseases Cardiovascular Diseases Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on June 17, 2013