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

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

Study Contact Backup

Study Locations

    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Hospital
        • Contact:
        • 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:
  • 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.
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:
  • Mucomyst(R)

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

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.

Clinical Trials on Kidney Failure, Chronic

Clinical Trials on N-acetylcysteine

Subscribe