Caffeine and Intermittent Claudication

NCT ID: NCT00388128

Last Updated: 2011-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-09-30

Brief Summary

The purpose of this study is to evaluate the change in Walking capacity after an intake of caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed, balance, cognitive function, health related quality of life (SF-36).

Detailed Description

PAD has a prevalence of 15-20 % in an elderly (>50) western population. PAD can not be seen in isolation but represents the peripheral manifestation of a generalized artherosclerosis. The co-morbidity with coronary or cerebralartherosclerosis depends on the degree of severity of PAD, the relative risk of a death (predominantly cardiac) is increased by a factor 4. From af medical and a socio-economic point of view there is the need to control the PAD complication rate and related treatment costs as effectively as possible.

The aim of any treatment of intermittent claudication is a clinically relevant improvement in the patient´s mobility and quality of life.

There is agreement, that physical training does improve the collateralisation of vascular lesions, the rheologic properties of blood and lead to a shift from glycolytic to oxidative muscle fibers in the working musculature which increases the capillary density. The effect of physical training is also to modify the patients risk factor profile, even moderate training increase the insulin receptor sensitivity and the fibrinolytic activity and decrease the dLDL/HDL ratio and the diastolic blood pressure in hypertensive patients - and thereby decrease the overall cardiac mortality.

This is a Phase 3, 12-week, double-blind, randomized, placebo-controlled cross-over and a follow-up study with 80 patients with intermittent claudication, half of which will be revascularized.

The objectives of this study are to evaluate the efficacy of caffeine (6mg/kg)and the revascularisation procedure. The primary end-point will be maximal walking distance (MWD) in both groups of patients. Other efficacy measures will include claudication onset time (PWD), changes in Ankle Brachial Index (ABI), Quality of Life (QoL), cognitive function, plasma response of Vascular Endothelian Growth Factor (VEGF, FGF). Safety variables will include routine hematology parameters and adverse events.

Conditions

Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Group Type: PLACEBO_COMPARATOR

Caffeine 6mg/kg

Intervention Type: DRUG

Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing

Interventions

Caffeine 6mg/kg

Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• men and women > 40 years
• history of IC of the lower extremities, Fontaine II
• ankle-brachial index (ABI)> 0.9 (subjects who are referred for a revasularizarition procedure)

Exclusion Criteria

• dementia
• diabetes
• illness or reason to be unable to participate, f.ex. general weakness, amputation or arthritis
• acute illness, f.ex. inflammation, unstable angina
• other reasons which contraindicate participation/treadmill exercise
• intake of Trental and/or Teofyllamin
• weight > 100kg

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herning Hospital

OTHER

Sponsor Role: collaborator

Central Jutland Regional Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Surgical Research Unit

Principal Investigators

Anne-Mette H Momsen, MPH, Phys, ph.D stud

Role: PRINCIPAL_INVESTIGATOR

Herning Hospital

Locations

Herning Hospital, Surgical research dep.

Herning, Central Jutland, Denmark

Countries

Denmark

References

Momsen AH, Jensen MB, Norager CB, Madsen MR, Vestersgaard-Andersen T, Lindholt JS. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication. Br J Surg. 2010 Oct;97(10):1503-10. doi: 10.1002/bjs.7149.

Reference Type: DERIVED

PMID: 20629111 (View on PubMed)

Other Identifiers

2006/168

Identifier Type: -

Identifier Source: secondary_id

2006-001902-10

Identifier Type: -

Identifier Source: org_study_id