Contact information
Type
Scientific
Primary contact
Dr Poay Huan Loh
ORCID ID
Contact details
Academic Cardiology Department
University of Hull
3rd Floor Houghton Building
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
+44 (0)1482 675009
huan.loh@hey.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084151408
Study information
Scientific title
Acronym
Study hypothesis
1. Whether enhanced external counterpulsation (EECP) results in improvement of heart muscle pumping function in ischaemic heart disease and heart failure patients.
2. The degree of improvement in the heart pumping function is related to the extent of impaired but viable heart muscle.
Ethics approval
Added 27 August 2008: approved by South Humber LREC in 2004, ref 04/Q1105/7.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular: Heart failure
Intervention
This is a randomised controlled trial comparing a course (35 sessions over 4 to 7 weeks) of standard (one hour) versus brief (5 minutes) sessions of EECP in patients with ischaemic heart disease and left ventricular systolic dysfunction to determined whether there is a difference between these interventions. Data from EECP suggests that 5-minute sessions are, in effect, a placebo. The intended follow-up period is 6 months after completion of EECP treatment course.
At baseline, patients will be investigated by physical examination, Minnesota Living with Heart Failure Questionnaires, echocardiogram (Echo), metabolic treadmill exercise test, blood tests, forearm flow-mediated dilatation (an ultrasound test of vascular function), and gadolinium-enhanced rest-stress cardiac cine-magnetic resonance imaging (CMR). The blood tests include N-terminal brain natriuretic peptide (or NT-BNP which is a marker for the presence of impaired heart muscle), troponin-T (marker for recent heart muscle injury or death), angiogenic factors (growth factors that stimulate the formation and growth of new blood vessels including vascular endothelial growth factor [VEGF], basic fibroblast growth factor [bFGF] and hepatocyte growth factor [HGF]), cytokines (protein molecules that involve in inflammation including highly specify C-reactive protein [hs-CRP], interleukin-1 beta [IL-1b], interleukin-6 [IL-6] and tumour necrosis factor alpha [TNF-a]) and creatinine (a marker for kidney function). A 24-hour urine collection will be done for urinary electrolytes and creatinine clearance (an estimation of kidney function).
Patients will then be randomised to the above interventions (ratio 1:1). Baseline investigations will be repeated 2 weeks and again 6 months after completion of the EECP course. All tests will be repeated at 3 months after treatment except CMR.
These data will provide the prevalence of a various substrates of heart muscle impairment in this patient population, their natural history over 6 months and their response to EECP treatment. The principal analyses will be a comparison between the randomised groups at baseline and during post-EECP follow-up.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Improvement in left ventricular function and coronary perfusion reserve based on assessment by gadolinium-enhanced rest/stress (adenosine) cine CMR.
2. To confirm the hypothesis that the degree of improvement in left ventricular function is affected by the extent of viable myocardium.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/08/2004
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
"Participant recruitment issue"
Eligibility
Participant inclusion criteria
Blood and urinary samples will be collected for the purpose of this study. Blood samples will be collected by a medical doctor or specialist nurse according to standard venesection method. 6mls of the blood will be analysed immediately by the local laboratory for NT-BNP, Troponin-T and hs-CRP. The other 8mls will be centrifuged and the plasma will be stored below -20 degree celcius. These will later be analysed using commercially available kits (R & D System, Abingdon, UK) for VEGF, bFGF, HGF, IL-1beta, IL-6 and TNF-a. This will be carried out by experience doctor with support from laboratory technician within the department. 24-hour urinary collection will be analysed in the local laboratory.
Inclusion criteria:
1. Over 18 years old
2. Male or female
3. Presence of LVSD with ejection fraction less than 40%
4. Known IHD stable on treatment 3 months prior to randomisation
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Total number of patients is 60 (randomised 1:1)
Participant exclusion criteria
1. Patients who have had an ischaemic event within the last 3 months
2. Contraindication to EECP
Recruitment start date
31/08/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Cardiology Department
Hull
HU3 2JZ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The North and South Bank Research and Development Consortium (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list