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Study Details

  • Full title of clinical trial: The Effect of Biventricular Pacing in Heart Failure with preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis
  • Study design: Single centre, mechanistic, random-order pilot. A Clinical Investigation of a medical device being used outside its approved indications.
  • Chief Investigator: Prof Zaheer Yousef
  • Sponsor: Cardiff and Vale University Health Board (ref 17-Dec-7164)
  • REC approval: 16/LO/1610
  • IRAS: 203878
  • MHRA approval: CI/2017/0052
  • Funding: Medtronic, Cardiff and Vale Charitable Endowment Fund
  • Trial registration: NCT03215849
  • Study protocol: TBC
  • Status: Open by invitation


Lay Summary

In most patients with heart failure the heart doesn’t empty properly when it contracts, and not enough blood is pumped out to meet the body’s needs. However, some patients have the same signs and symptoms despite their hearts emptying quite well. These patients have ‘heart failure with preserved ejection fraction’ (HFpEF). For these patients their hearts don’t work well during exercise. There are few treatments available and cardiac pacemakers are not generally used.

In the MAPPLE study, up to 10 patients with HFpEF will have a pacemaker fitted. We will test whether a pacemaker that co-ordinates the left and right side of the heart (biventricular pacing) might help it work better during exercise. Participants will have 3 sessions of cycle exercise tests and echocardiograms at Cardiff Metropolitan University School of Health and Sport Sciences. Three types of cardiac pacing will be tested to see if there is any difference between them before and after exercise.

CEDAR's Role

This Clinical Investigation was originally sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust with the support of Norwich Clinical Trials Unit. Cardiff and Vale University Heath Board joined the study, became the sole study site, and managed to recruit 1 patient before the Covid pandemic shut down all non-essential clinical research. The study is now restarting with Cardiff and Vale University Hospital Board as the new Sponsor and Prof Yousef as Chief Investigator. CEDAR has taken over the role of CTU, and the study design, documentation, and database are all adapted from those developed by the previous study management.

  • adapting and updating the Clinical Investgation Plan and patient-facing documents
  • updating and administering the study database
  • managing amendments and approvals on behalf of the Sponsor
  • co-ordinating the Trial Management Group
  • monitoring and safety reporting
  • supporting analysis and report writing by the clinical researchers