Clinical Trial: Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Does a Measure Exist in the Right Ventricle Which Can Act as a Surrogate Marker for Future Ventriclar Sysfunction When Pacing - a Pilot Study

Brief Summary:

This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population who are clinically indicated to receive a pacemaker.

When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat.

Increasingly the available evidence suggests that long term RV pacing is associated with complications - left ventricule (LV) dysfunction, heart failure, atrial fibrillation (AF) and death in some patients. What we do not see are a large proportion of all patients who receive pacemakers suffering pacing related adverse effects.

If there could be a way of identifying those patients in the group who go on to develop pacing induced cardiomyopathy at the time of initial pacing implant, this would be a very valuable clinical measure. These patients could be identified from the outset and paced with a biventricular device to avoid the pacing induced cardiomyopathy. Whilst much energy has been directed towards the LV as a focus of the clinical markers of disease, little has been published looking at RV haemodynamics.

We plan to study a cohort of patients who are clinically indicated to receive a pacemaker and study their RV in detail at the time of implantation. We will use conductance catheters and echocardiography to determine measures of pumping function. We will then follow them up for a period of six month using echocardiography and blood markers of heart dysfunction. In those patients who have a reduction in heart function we will then look for common patterns within their initial measurements.


Detailed Summary:

This study is designed to explore whether a marker exists within the right ventricle (RV) that may suggest future pacing induced dysfunction of the heart. Pacing the heart is a necessary procedure when normal conduction has failed. It has been shown in some patients to result in deleterious effects on the pumping function of the left ventricle acutely and chronically. Little has been looked into within right ventricular function and how this interacts with the left side. The fact that this dysfunction is not seen in all patients who receive pacemakers is important and we aim to use these pure haemodynamic measures to investigate this issue and try to identify those patients who may go on to have pacing induced dysfunction. This is an important scientific question to answer as we know that these patients can be spared the ventricular dysfunction by the intervention of biventricular pacing at the time of initial implantation. What we do not know is how to choose this group at the outset.

The study has been designed as a pilot investigation using patients who are to undergo permanent pacemaker therapy. Our study will entail one additional catheter being passed to the heart and also one to the inferior vena cava. This measurement of heart function will be performed directly after the implantation of the pacemaker and will add only a small amount of time to the case.

We will then follow these patients up and take echocardiographic data as well as blood markers of impaired ventricular function at 6 months.

The design of this study is that of a cohort study with the common exposure being that of pacemaker therapy. We seek to take detailed haemodynamic and echocardiographic measurements at the time of implantation. This will yield powerful data when cross referenced to cases of adv
Sponsor: Basildon and Thurrock University Hospitals NHS Foundation Trust

Current Primary Outcome: surrogate marker [ Time Frame: 30 minutes ]

To identify any surrogate markers for this patient cohort


Original Primary Outcome: Same as current

Current Secondary Outcome: dyssynchronous index [ Time Frame: 30 minutes ]

To identify if any dyssynchronour index can be obtained in the right ventricle in this cohort


Original Secondary Outcome: Same as current

Information By: Basildon and Thurrock University Hospitals NHS Foundation Trust

Dates:
Date Received: July 22, 2014
Date Started: July 2014
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016