Heart Failure, CongestivePhase 2/3NCT00532688
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
A Phase 2/3 study testing N-acetylcysteine in people with Heart Failure, Congestive and Kidney Failure, Chronic, run by Bayside Health at 1 site in Australia.
Trial summary
Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Congestive, Kidney Failure, Chronic
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2007to Feb 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Anthony Camuglia, MBBS(Hons), 90762000, anthonycamuglia@gmail.com
David Kaye, PhD, FRACP
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Congestive, Kidney Failure, Chronic
- Being tested
- N-acetylcysteine
- Keywords
- acetylcysteine, N-acetylcysteine, heart failure, renal failure
- Medical subject headings
- Heart Failure, Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called Mucomyst(R)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: N-acetylcysteine |
| 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. Receives: Drug: N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function via non invasive ultrasound measured flow mediated dilatation
Measured: baseline, 4 weeks and 9 weeks
Estimated glomerular filtration rate calculated with Cockroft Gault equation.
Measured: baseline, 4 weeks, 9 weeks
Secondary outcomes (3)
Symptoms of heart failure
Measured: baseline, 4 weeks, 9 weeks
Death
Measured: baseline, 4 weeks, 9 weeks
Serum BNP (brain natriuretic peptide)
Measured: baseline, 4 weeks, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startSep 2007
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- The Alfred
- Investigators
- David Kaye, PhD FRACP, Principal investigator, Alfred Heart CentreAnthony Camuglia, MBBS, Principal investigator, The AlfredCatherine Farrrington, Principal investigator, Alfred Heart CentreJenny Starr, Principal investigator, Alfred Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532688
- Sponsor's protocol ID
- 132/07
- Status last verified
- Sep 2007
- First submitted
- 19 Sep 2007
- Last updated
- 20 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Camuglia AC, Maeder MT, Starr J, Farrington C, Kaye DM. Impact of N-acetylcysteine on endothelial function, B-type natriuretic peptide and renal function in patients with the cardiorenal syndrome: a pilot cross over randomised controlled trial. Heart Lung Circ. 2013 Apr;22(4):256-9. doi: 10.1016/j.hlc.2012.10.012. Epub 2012 Dec 7.
PubMed 23219310
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.
- ClinicalTrials.gov ID
- NCT00532688
- Acronym / sponsor ID
- 132/07
- Conditions
- Heart Failure, Congestive, Kidney Failure, Chronic
- Keywords
- acetylcysteine, N-acetylcysteine, heart failure, renal failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- The Alfred
- Study start
- Sep 2007
- Study completion
- Feb 2008 (estimated)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: N-acetylcysteine5 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. |
| 2 | Placebo comparator | Drug: N-acetylcysteine28 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineAlso: Mucomyst(R)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. | Drug | 1, 2 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
- Derived from this study: PubMed 23219310Camuglia AC, Maeder MT, Starr J, Farrington C, Kaye DM. Impact of N-acetylcysteine on endothelial function, B-type natriuretic peptide and renal function in patients with the cardiorenal syndrome: a pilot cross over randomised controlled trial. Heart Lung Circ. 2013 Apr;22(4):256-9. doi: 10.1016/j.hlc.2012.10.012. Epub 2012 Dec 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kaye, PhD FRACP principal investigator
Alfred Heart Centre
Anthony Camuglia, MBBS principal investigator
The Alfred
Catherine Farrrington principal investigator
Alfred Heart Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing N-acetylcysteine in people with Heart Failure, Congestive and Kidney Failure, Chronic, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Kaye, PhD FRACP (610390762000, david.kaye@baker.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular function via non invasive ultrasound measured flow mediated dilatation (time frame: baseline, 4 weeks and 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00532688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2007.