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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03844113




Registration number
NCT03844113
Ethics application status
Date submitted
12/02/2019
Date registered
18/02/2019
Date last updated
29/12/2020

Titles & IDs
Public title
Carnosine for Peripheral Vascular Disease
Scientific title
Carnosine for Peripheral Vascular Disease
Secondary ID [1] 0 0
Car-PVD
Universal Trial Number (UTN)
Trial acronym
Car-PVD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carnosine
Treatment: Drugs - Placebo

Active comparator: Intervention - Each participant will be given a daily oral dose 2 g of carnosine for 6 months

Placebo comparator: Control - Each participant will be given a daily oral dose 2 g of placebo for 6 months


Treatment: Drugs: Carnosine
Each participant will be given a daily oral dose 2 g of carnosine for 6 months

Treatment: Drugs: Placebo
Each participant will be given a daily oral dose 2 g of methycellulose powder for 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
walking endurance
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* Age >=40or <80 years
* Clinical diagnosis Peripheral Vascular disease
* Rutherford Grade 1-3
* No significant kidney, cardiovascular, haematological, respiratory, gastrointestinal, or central nervous system disease, as well as no psychiatric disorders, no active cancer within the last five years; no presence of acute inflammation (by history, physical or laboratory examination)
* Intermittent claudication on treadmill between 30m and 200m
* Ankle Brachial index 0.6-1 at rest with minimum post exercise drop in ABI of 0.1
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age < 40 or > 80 years
* Pregnant or lactating
* Limb threatening ischaemia- Rutherford grades 4-6, manifested by ischaemic rest pain, ulceration, or gangrene; acute limb-threatening ischaemia
* lower limb surgical or endovascular interventions in the preceding 6 months
* planned lower limb endovascular or surgical intervention within the next 6 months on either limb
* taking medication for PVD (Cilostazol and Pentoxifylline)
* inability to complete the treadmill walking test for reasons other than claudication
* myocardial infarction within last 3 months
* deep vein thrombosis within 3 months
* estimated life expectancy < 1 year
* alcohol and illicit drug abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Centre for Health Research and Implementation - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The investigators hypothesise that a home-based standardised exercise intervention with 2g of carnosine daily for 6 months will improve walking endurance in 104 patients with PVD aged 40-80 years compared to placebo and exercise through stabilisation of HIF1-a in the ischaemic leg.

Aims

Aim 1: Determine whether in patients with PVD, carnosine in addition to exercise improves:

1. walking endurance (6-min walk test; primary outcome);
2. initial claudication distance (ICD), and absolute claudication distance (ACD; treadmill), cadence, resting and exercise ABI; and
3. central blood pressure, endothelial function, arterial (aortic) stiffness, lipid profile; and
4. quality of life as determined by EuroQol-5D (all secondary outcomes).
5. Improve cognitive function (global cognitive score formed by a composite of 7 cognitive tests)

Aim 2: Delineate the mechanisms by which carnosine improves walking endurance:

1. protein expression of pro-angiogenic and carnosine related genes, including carnosine transporters in the skeletal muscle biopsies, EPCs in peripheral blood and quantitative proteomic studies.
2. other mechanisms demonstrated in animal studies including plasma inflammatory markers, serum and urinary advanced glycation (AGE) and lipoxidation (ALE) end-products (tertiary outcomes).

This trial will provide evidence for use of carnosine as a therapeutic intervention for PVD patients and, if positive, will have immediate clinical application.
Trial website
https://clinicaltrials.gov/study/NCT03844113
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbora deCourten, MD,PHD,MPH
Address 0 0
Monash University and Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Barbora deCourten, MD,PHD,MPH
Address 0 0
Country 0 0
Phone 0 0
+610385722651
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03844113