Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
16/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof MP Frenneaux

ORCID ID

Contact details

Cardiac Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265160803

Study information

Scientific title

Acronym

Study hypothesis

1. Does biventricular pacing improve heart function on exercise?
2. What effect does a reduction of blood in the heart have on blood vessels in the forearm?
3. How does heart wall movement relate to heart contraction and the volume of blood within the heart chambers?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular

Intervention

Plan of investigation
Morning study (8.30-11.00 a.m.) - Lower Body Negative Pressure (LBNP) studies.
Patient will be allocated to pacemaker ON or OFF (Investigators will be blinded to the pacemaker mode)

08.30
9.00 Injection of Stannous Agent - patient will then enter LBNP
9.20 Radio-labelling of red blood cells with technetium
9.30 Re-injection of red blood cells

Study begins
9.30 LBNP switched on at 0 mmHg and baseline echo
9.30 LBNP switched to 30 mmHg and repeat echo
9.40 LBNP switched to 40 mmHg and repeat echo
9.45 LBNP off and rest period
9.55 LBNP switched on at 0 mmHg and baseline LV volume and FVR
10.00 LBNP switched to 30 mmHg and LV volume and FVR
10.05 LBNP switched to 40 mmHg and LV volume and FVR
10.10 LNBP off and rest period
10.20 Patient will repeat the above study in the opposite (ON/OFF) mode

Lunch break (11.00am -12.00pm) - During this period the pacemaker will be returned to the ON mode.

Afternoon study (12.00 - 1.40 pm) - Exercise studies

Patients will be allocated to pacemaker ON or OFF (Investigators will be blinded to the Pacemake mode)

Subject will sit on a recline cycle ergometer - Study Begins

12.00 Baseline cardiac radionuclide scan (CRS) and Cardiac output (CO)
12.05 Exercise at 30% of pre-determined maximal exercise capacity with CRS + CO
12.10 Exercise at 50% of pre-determined maximal exercise capacity with CRS + CO
12.15 Exercise at 70% of pre-determined maximal exercise capacity with CRS + CO
12.20 Rest period
13.20 Patient will repeat the above study in the opposite (ON/OFF) mode
13.40 Study completed

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

13/07/2005

Overall trial end date

13/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be identified from Professor Frenneaux’s Heart Failure clinic who have already had a biventricular pacemaker implanted for clinical reasons. These patients will be approached by Professor Frenneaux or a member of his Research team and informed of the study. If the patients are interested in taking part they will be sent a copy of the patient information sheet and a reply letter. If they agree to take part they will be contacted and recruited into the study.

Inclusion criteria:
1. NYHA Class I-III heart failure
2. Implanted with a biventricular pacemaker in the preceding 12 months
3. Physically capable of performing a cycle exercise test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. NYHA Class IV heart failure
2. Terminal illness
3. Women of child-bearing potential
4. Women currently breast-feeding
5. Significant arthritis limiting ability to perform a cycle exercise test

Recruitment start date

13/07/2005

Recruitment end date

13/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiac Medicine
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

University Hospital Birmingham NHS Trust (UK)

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