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N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

Primary Purpose

Heart Failure, Congestive, Kidney Failure, Chronic

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
Bayside Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring acetylcysteine, N-acetylcysteine, heart failure, renal failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alfred HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Vascular function via non invasive ultrasound measured flow mediated dilatation
Estimated glomerular filtration rate calculated with Cockroft Gault equation.

Secondary Outcome Measures

Symptoms of heart failure
Death
Serum BNP (brain natriuretic peptide)

Full Information

First Posted
September 19, 2007
Last Updated
September 19, 2007
Sponsor
Bayside Health
Collaborators
The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT00532688
Brief Title
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
Official Title
Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bayside Health
Collaborators
The Alfred

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Kidney Failure, Chronic
Keywords
acetylcysteine, N-acetylcysteine, heart failure, renal failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
Mucomyst(R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vascular function via non invasive ultrasound measured flow mediated dilatation
Time Frame
baseline, 4 weeks and 9 weeks
Title
Estimated glomerular filtration rate calculated with Cockroft Gault equation.
Time Frame
baseline, 4 weeks, 9 weeks
Secondary Outcome Measure Information:
Title
Symptoms of heart failure
Time Frame
baseline, 4 weeks, 9 weeks
Title
Death
Time Frame
baseline, 4 weeks, 9 weeks
Title
Serum BNP (brain natriuretic peptide)
Time Frame
baseline, 4 weeks, 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Kaye, PhD FRACP
Phone
610390762000
Email
david.kaye@baker.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Camuglia, MBBS(Hons)
Phone
610390762000
Email
anthonycamuglia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kaye, PhD FRACP
Organizational Affiliation
Alfred Heart Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Camuglia, MBBS
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Farrrington
Organizational Affiliation
Alfred Heart Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jenny Starr
Organizational Affiliation
Alfred Heart Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Camuglia, MBBS(Hons)
Phone
90762000
Email
anthonycamuglia@gmail.com
First Name & Middle Initial & Last Name & Degree
David Kaye, PhD, FRACP
First Name & Middle Initial & Last Name & Degree
Anthony Camuglia, MBBS(Hons)
First Name & Middle Initial & Last Name & Degree
Catherine Farrington
First Name & Middle Initial & Last Name & Degree
Jenny Starr

12. IPD Sharing Statement

Citations:
PubMed Identifier
23219310
Citation
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.
Results Reference
derived

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N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

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