NCT00532688

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

September 19, 2007

Last Update Submit

September 19, 2007

Conditions

Heart Failure, CongestiveKidney Failure, Chronic

Keywords

acetylcysteineN-acetylcysteineheart failurerenal failure

Outcome Measures

Primary Outcomes (2)

  • Vascular function via non invasive ultrasound measured flow mediated dilatation

    baseline, 4 weeks and 9 weeks

  • Estimated glomerular filtration rate calculated with Cockroft Gault equation.

    baseline, 4 weeks, 9 weeks

Secondary Outcomes (3)

  • Symptoms of heart failure

    baseline, 4 weeks, 9 weeks

  • Death

    baseline, 4 weeks, 9 weeks

  • Serum BNP (brain natriuretic peptide)

    baseline, 4 weeks, 9 weeks

Study Arms (2)

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

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

Interventions

N-acetylcysteineDRUG

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.

Also known as: Mucomyst(R)
12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23219310DERIVED

MeSH Terms

Conditions

Heart FailureKidney Failure, ChronicRenal Insufficiency

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRenal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Kaye, PhD FRACP

CONTACT

610390762000david.kaye@baker.edu.au

Anthony Camuglia, MBBS(Hons)

CONTACT

610390762000anthonycamuglia@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 20, 2007

Study Start

September 1, 2007

Study Completion

February 1, 2008

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

AU(1)