Brief Summary

The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control group of patients implanted with an Implantable Cardioverter-Defibrillator (ICD) or a permanent pacemaker (PPM) with systolic HF (LVEF ≤35%). This clinical investigation is a prospective, single-centre cohort study. Each participant will be followed for 6 months. The study will collect data over 3 years; 2.5 years for enrolment and 6 months until the last participant completes the last 6-month follow-up visit. N.B: COGNI-CRT does NOT affect the patient's care pathway - the patients who will be selected for participation are those who have already been referred for the device implant. The ONLY difference to the patient's care pathway caused by COGNI-CRT is the addition of a battery of cognitive function tests, which involves asking the patient questions and asking them to complete questionnaire-like cognitive tests. NTpro-BNP levels, NYHA classification and LVEF will be measured prior to device implantation and at 6-months post-implant to assess the device's impact on the participant's heart failure (and CRT response). N.B: NT-proBNP, NYHA classification and LVEF are all parts of the patient's standard care pathway, COGNI-CRT is just utilising the data collected as part of the investigation. The main study arm and control group allows COGNI-CRT to assess 3 potential outcomes for patients with severe HF (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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Trial recruitment is currently suspended

Enrollment

198

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.6 years study duration

First Submitted

Initial submission to the registry

November 21, 2018

Completed

7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed

7 months until next milestone

Study Start

First participant enrolled

June 21, 2019

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2024

Completed

Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

4.6 years

First QC Date

November 21, 2018

Last Update Submit

July 29, 2022

Conditions

Cognitive Impairment Cognitive Change Heart Failure, Systolic Heart Failure Cognitive Impairment, Mild Left Ventricular Dysfunction Left Ventricular Systolic Dysfunction Systolic Dysfunction Systolic Heart Failure

Keywords

Cognitive ImpairmentLeft Ventricular Systolic DysfunctionHeart FailureCardiac Resynchronisation TherapyImplantable Cardioverter-DefibrillatorPacemakerCRTICDPPM

Outcome Measures

Primary Outcomes (1)

Change in cognitive function at 6 months post-implant
Measured by the use of a 5-stage cognitive battery test
6 months

Secondary Outcomes (3)

Change in left ventricular ejection fraction (LVEF) at 6 months
6 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Test at 6 months
6 months
Change in New York Heart Association (NYHA) Functional Classification
6 months

Study Arms (2)

CRT: Main Arm

Cardiac Resynchronisation Therapy (CRT): Main Arm \~98 participants Prior to CRT Implantation \& Post-Implant 6-Month Device Follow-Up Clinic: \- Battery of 5 questionnaire-based cognitive tests, including the Test of Premorbid Functioning, Repeatable Battery for the Assessment of Neuropsychological Status, Hospital Anxiety and Depression Scale, Frontal Assessment Battery and Trail Making Test Part A and B Please note, the Test of Premorbid Functioning will only be performed ONCE at Pre-Assessment as results reflect IQ prior to disease onset.

Diagnostic Test: Repeatable Assessment of Neuropsychological StatusDiagnostic Test: Hospital Anxiety and Depression ScaleDiagnostic Test: Frontal Assessment BatteryDiagnostic Test: Trail Making Test Part A and BDiagnostic Test: Test of Premorbid Functioning

ICD and PPM: Control Arm

Implantable Cardioverter-Defibrillator (ICD) and Permanent Pacemaker (PPM): Control Arm \~98 participants Prior to ICD or PPM Implantation \& Post-Implant 6-Month Device Follow-Up Clinic: \- Battery of 5 questionnaire-based cognitive tests, including the Test of Premorbid Functioning Repeatable Battery for the Assessment of Neuropsychological Status, Hospital Anxiety and Depression Scale, Frontal Assessment Battery and Trail Making Test Part A and B Please note, the Test of Premorbid Functioning will only be performed ONCE at Pre-Assessment as results reflect IQ prior to disease onset.