Caffeine and Intermittent Claudication

Intermittent Claudication Clinical Trial

Official title:

Effects of Caffeine in Patients With Intermittent Claudication.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388128
• Other study ID #: 2006-001902-10
• Secondary ID: 2006/168
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2006
• Last updated: June 8, 2011
• Start date: September 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

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

Locations

Country	Name	City	State
Denmark	Herning Hospital, Surgical research dep.	Herning	Region Central-Jutland

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Central Jutland Regional Hospital, Herning Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		during test 1 and 3	No
Primary	Maximum walking distance		during treadmill test	No
Secondary	Painfree Walking Distance		treadmill test	No
Secondary	Max muscle strength (MVC) of kneeextension		At end of each test	No
Secondary	Endurance of 50%MVC kneeextension		At end of each test	No
Secondary	Postural stability		in all tests	No
Secondary	Reaction speed		in all tests	No
Secondary	Cognitive function		in all tests	No
Secondary	Walking Impairment Questionnaire		in first and third test	No
Secondary	vascular endothelian growth factors VGF. FGF		before and after 1. and 2. test	No