COGNI-CRT version 1

• Research type

  Research Study

• Full title

  Can COGNItive Function be improved by Cardiac Resynchronisation Therapy?

• IRAS ID

  251230

• Contact name

  Hannah Ford

• Contact email

  hannah.ford6@nhs.net

• Sponsor organisation

  Royal Cornwall Hospital NHS Trust

• Clinicaltrials.gov Identifier

  NCT03755570, Clinicaltrials.gov

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  It is known that patients with heart failure (HF) are prone to cognitive impairment, with a possible mechanism being cerebral hypoperfusion. The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (Left Ventricular Ejection Fraction (LVEF) ≤35%), when compared to a control group of patients implanted with an Implantable Cardioverter-Defibrillator (ICD) or permanent pacemaker (PPM) with systolic HF (LVEF ≤35%).
  The main study arm and control group allows assessment of 3 potential outcomes for patients with LVEF <35%:-
  1. Cognitive function is not improved by CRT, ICDs or PPMs
  2. Cognitive function can be improved by the assurance of rate control offered by CRT, ICDs and PPMs
  3. Cognitive function can be improved by the assurance of ventricular synchronisation and rate control provided by the additional left ventricular lead in CRT devices

  Using LVEF <35% in both arms contributes to comparable baseline characteristics. Patients’ cognitive function, NYHA scale, LVEF and NT-proBNP levels will be recorded at prior to device implantation and at the Post-Implant 6-Month Device Follow-Up Visit. Comparing NYHA scale, LVEF and BNP will identify if patients have responded to the CRT and may demonstrate the potential benefit of CRT over ICD or PPM.

  Care will be taken to ensure patients are receiving care to ensure medications are optimised according to the Consultant Cardiologist, or in the process of being optimised. Medications, co-morbidities, blood pressure and defibrillation therapy will be recorded to assess the potential impact this may have on cognitive function.

  Device selection will be in line with published international guidelines. All patients listed for device implant will be via an MDT process. All hospital visits for participants will be routine and mandatory as the standard care pathway, and COGNI-CRT does not require participants to make additional visits to hospital.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  18/LO/2242

• Date of REC Opinion

  25 Apr 2019

• REC opinion

  Further Information Favourable Opinion