Biventricular Pacing and Cardiac Physiology
| 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
Scientific
Cardiac Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 13/07/2005 |
| Completion date | 13/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/07/2005 |
| Date of final enrolment | 13/07/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiac Medicine
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
