Biventricular Pacing and Cardiac Physiology

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN75745362
• Date of registration: 29/09/2006
• Prospective Registration: No
• Primary sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health
• Public title: Biventricular Pacing and Cardiac Physiology
• Date of first enrolment: 13/07/2005
• Target sample size: 0
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN75745362
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: MP Frenneaux

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular
Circulatory System

Intervention(s)

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

Primary Outcome(s)

Not provided at time of registration

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

N0265160803

Source(s) of Monetary Support

University Hospital Birmingham NHS Trust (UK)