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 Frenneauxs 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
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