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Purpose: The purpose of this clinical research is to determine whether heart resynchronization therapy may improve cognitive function in patients with systolic heart failure in patients with systolic heart failure compared to a comparison group of patients treated with an implantable cardioverter-defibrillator or permanent pacemaker with systolic heart failure. Any improvement in cognitive function that is identified between pre- and post- CRT implant will be determined by the CRT therapy, not due to a placebo effect or owing to a learning outcome, and not due to a placebo effect or due to a learning result. Participants with the inclusion or exclusion criteria determined by the study's authors Group A: When compared to a control group of patients receiving an ICD or PPM with systolic heart failure, CRT can increase cognitive function in patients with systolic heart failure patients. To determine if CRT can enhance cognitive function, we can determine whether PRT can improve cognitive function. To determine if cognitive enhancements can lead to LVEF growth/stability/and/or NYHA decrease, see the following aims: To determine whether CRT can improve cognitive function. Both parts of TMT involve circles dotted over a piece of paper, the circles for Part A are marked with the number 1 - 25, and the patient must draw a line connecting the numbers in ascending order, i. e. "1-A-2-B3-C" "u2026")" is one of the few CRT devices evaluated before device placement and at the Post-Implant 6-Month Device Follow-Up Visit, CRT Measures will be performed prior to device installation and at the Post-Implant 6-Month Device Follow-Up Visit. NT-proBNP: The patient's regular blood tests prior to device implantation and the Post-Implant 6-Month Device Follow-Up Visit, where blood testing is routine for heart failure patients every 6 months is common. A NYHA scale analysis will be performed during the screening clinics prior to device implantation and at the Post-Implant 6-Month Device Follow-Up Visit, using the standardised NYHA questionnaires developed for the purpose of this trial. Before and after the ICD or PPM implant, a test will be used to compare cognitive function among patients before and after CRT placement, as well as in the control group before and after ICD or PPMimplantation. The estimated CRT sample size to power the study, according to sample size results, is expected to be 99 participants. A further 99 ICD and PPM participants will be recruited by the control group in a similar way to the main study group.
Source link: https://clinicaltrials.gov/ct2/show/NCT03755570
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