Caffeine and Intermittent Claudication
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00388128|
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Claudication||Drug: Caffeine 6mg/kg||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Caffeine in Patients With Intermittent Claudication.|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||September 2009|
|Placebo Comparator: A||
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388128
|Herning Hospital, Surgical research dep.|
|Herning, Region Central-Jutland, Denmark, 7400|
|Principal Investigator:||Anne-Mette H Momsen, MPH, Phys, ph.D stud||Herning Hospital|