ISRCTN ISRCTN75745362
DOI https://doi.org/10.1186/ISRCTN75745362
Secondary identifying numbers N0265160803
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
16/07/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof MP Frenneaux
Scientific

Cardiac Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular
InterventionPlan 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date13/07/2005
Completion date13/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients 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
Key exclusion criteria1. 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
Date of first enrolment13/07/2005
Date of final enrolment13/07/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cardiac Medicine
Birmingham
B15 2TH
United Kingdom

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

University Hospital Birmingham NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan