Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

"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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes