Caffeine and Intermittent Claudication - Full Text View

Sponsor:	University of Aarhus
Collaborators:	Herning Hospital Viborg Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00388128

Purpose

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).

Condition	Intervention	Phase
Intermittent Claudication	Drug: Caffeine 6mg/kg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Caffeine in Patients With Intermittent Claudication.

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Quality of life [ Time Frame: during test 1 and 3 ] [ Designated as safety issue: No ]
Maximum walking distance [ Time Frame: during treadmill test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Painfree Walking Distance [ Time Frame: treadmill test ] [ Designated as safety issue: No ]
Max muscle strength (MVC) of kneeextension [ Time Frame: At end of each test ] [ Designated as safety issue: No ]
Endurance of 50%MVC kneeextension [ Time Frame: At end of each test ] [ Designated as safety issue: No ]
Postural stability [ Time Frame: in all tests ] [ Designated as safety issue: No ]
Reaction speed [ Time Frame: in all tests ] [ Designated as safety issue: No ]
Cognitive function [ Time Frame: in all tests ] [ Designated as safety issue: No ]
Walking Impairment Questionnaire [ Time Frame: in first and third test ] [ Designated as safety issue: No ]
vascular endothelian growth factors VGF. FGF [ Time Frame: before and after 1. and 2. test ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2006
Study Completion Date:	September 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A	Drug: Caffeine 6mg/kg Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388128

Locations

Denmark
Herning Hospital, Surgical research dep.
Herning, Region Central-Jutland, Denmark, 7400

Sponsors and Collaborators

University of Aarhus

Herning Hospital

Viborg Hospital

Investigators

Principal Investigator:

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

Herning Hospital

More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Regional Hospital Herning, Surgical Research Unit
ClinicalTrials.gov Identifier:	NCT00388128 History of Changes
Other Study ID Numbers:	2006-001902-10, 2006/168
Study First Received:	October 12, 2006
Last Updated:	June 8, 2011
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee

Keywords provided by University of Aarhus:

Intermittent Claudication
PAD
Caffeine
Walking capacity

ABI
QoL
Growth factor

Additional relevant MeSH terms:

Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 21, 2012