A Phase 3 interventional study of Caffeine 6mg/kg in Intermittent Claudication, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-06-09.
Sponsored by University of Aarhus · Phase 3, Interventional, and Treatment
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).
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.
260 studies on the registry are indexed under Intermittent Claudication; 45 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 204 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Drug: Caffeine 6mg/kg
Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing
Quality of life
Time frame: during test 1 and 3
Maximum walking distance
Time frame: during treadmill test
Painfree Walking Distance
Time frame: treadmill test
Max muscle strength (MVC) of kneeextension
Time frame: At end of each test
Endurance of 50%MVC kneeextension
Time frame: At end of each test
Postural stability
Time frame: in all tests
Reaction speed
Time frame: in all tests
Cognitive function
Time frame: in all tests
Walking Impairment Questionnaire
Time frame: in first and third test
vascular endothelian growth factors VGF. FGF
Time frame: before and after 1. and 2. test
The record gives a start of Sep 2006, a primary completion of May 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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