Carnosine for Peripheral Vascular Disease

NCT03844113 | Unknown Phase 2 DMC

• 1 other identifier: Car-PVD
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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-α in the ischaemic leg. Aims Aim 1: Determine whether in patients with PVD, carnosine in addition to exercise improves:

1. 1.walking endurance (6-min walk test; primary outcome);
2. 2.initial claudication distance (ICD), and absolute claudication distance (ACD; treadmill), cadence, resting and exercise ABI; and
3. 3.central blood pressure, endothelial function, arterial (aortic) stiffness, lipid profile; and
4. 4.quality of life as determined by EuroQol-5D (all secondary outcomes).
5. 5.Improve cognitive function (global cognitive score formed by a composite of 7 cognitive tests)
6. 6.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.
7. 7.other mechanisms demonstrated in animal studies including plasma inflammatory markers, serum and urinary advanced glycation (AGE) and lipoxidation (ALE) end-products (tertiary outcomes).

Conditions

Peripheral Arterial Disease

Keywords

carnosine; peripheral arterial disease

Outcome Measures

Primary Outcomes (1)

• walking endurance

  change in walking endurance (6-min walk test)

  6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Drug: Carnosine

Control

PLACEBO COMPARATOR

Each participant will be given a daily oral dose 2 g of placebo for 6 months

Drug: Placebo

Interventions

Carnosine DRUG

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

Also known as: Pure Carnosine

Intervention

Placebo DRUG

Each participant will be given a daily oral dose 2 g of methycellulose powder for 6 months

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monash University: lead
• Monash Health: collaborator

Study Sites (1)

Monash Centre for Health Research and Implementation

Melbourne, Victoria, 3168, Australia

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Barbora deCourten, MD,PHD,MPH

  Monash University and Monash Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbora deCourten, MD,PHD,MPH

CONTACT

+610385722651; barbora.decourten@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: parallel assignment

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 18, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)