An observational study in Heart Failure, Systolic, Morality and Cognitive Impairment, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Chang Gung Memorial Hospital · Observational
In heart failure patients, neuropsychological disorders have been prospectively linked to frequent hospitalizations, recurrent cardiac events, and mortality. Cognitive dysfunction is also a frequent comorbidity in heart failure (HF) patients. The benefit of cardiac rehabilitation between patients with cognitive dysfunction and patients without cognitive dysfunction is unknown. Investigators hypothesize that patients with cognitive dysfunction benefit more from cardiac rehabilitation programs than patients without cognitive dysfunction.
Investigators retrospectively reviewed HF patients discharged from acute HF hospitalizations between March 2015 and May 2021 at the heart failure center, Kaohsiung Chang Gung Memorial Hospital. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. Participants may have cognitive impairment when their LNNB-S >=10. A heart failure disease management program was delivered to all patients before discharge, including an HF specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. Participants were advised to receive phase II cardiac rehabilitation (CR) after the cardiopulmonary exercise test (CPET) within one month. Moderate continuous aerobic exercise training was prescribed individually according to the CPET result. Participants who received at least one exercise session of phase II CR were considered as receiving CR. Other participants were considered non-receiving CR. Kaplan-Meier curves and log-rank test were constructed to compare the composite endpoint and all-causes mortality in four groups (Group a: Candidates without cognitive impairment and receiving CR. Group b: Candidates without cognitive impairment and not-receiving CR. Group c: Candidates with cognitive impairment and receiving CR. Group d: Candidates with cognitive impairment and not-receiving CR.)
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 247 is above the median of 200 across 1,678 observational studies indexed under Heart Failure.
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Investigators retrospectively reviewed 247 HF patients who were discharged from an acute HF hospitalization. LNNB-S was assessed in all patients. Multivariate Cox Regression by enter method was used to determine significant predictors for all-cause mortality and composite endpoints. Kaplan-Meier curves and log-rank test were constructed to compare the composite endpoint and all-causes mortality according to cognitive impairment and receiving CR.
Exclusion Criteria:
As one of the core components of multidisciplinary CR, psychiatrist and psychologist consultation was delivered to all patients. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. The evaluation would be completed during admission. The initial LNNB was condensed to fifteen items for the screen test by Golden. LNNB-S Chinese version focuses on 3 domains, including number calculation, cognitive function, and rhythm control. In our participants' cohort, investigators choose LNNB-S \>=10 as a cutoff point. That is, participants may have cognitive impairment when their LNNB-S \>=10.
Other: multidisciplinary cardiac rehabilitation
As one of the core components of multidisciplinary CR, psychiatrist and psychologist consultation was delivered to all patients. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. The evaluation would be completed during admission. The initial LNNB was condensed to fifteen items for the screen test by Golden. LNNB-S Chinese version focuses on 3 domains, including number calculation, cognitive function, and rhythm control. In our participants' cohort, investigators choose LNNB-S \>=10 as a cutoff point. That is, participants may have cognitive impairment when their LNNB-S \>=10.
Other: multidisciplinary cardiac rehabilitation
A heart failure disease management program was delivered to all patients before discharge, including an HF specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. Participants were advised to receive phase II CR after the CPET within one month. Moderate continuous aerobic exercise training was prescribed individually according to the CPET result.4 The training intensity was within 10 beats of the anaerobic threshold or 40-60% of peak VO2. The training intensity was gradually increased fortnightly as tolerated (Borg's scale of 12-14). Phase II CR consisted of 12 weeks of 36 sessions in the entire course. Patients who received at least one exercise session were considered as receiving CR. Other patients were considered non-receiving CR.
composite of all-cause mortality or HF hospitalization
Number of participants that had an occurrence of the mortality which is defined as all-cause mortality or occurrence of HF hospitalization
Time frame: March, 2015 ~ May, 2021
all-cause mortality
Number of participants that had occurrence of the mortality which is defined as all-cause mortality
Time frame: March, 2015 ~ May, 2021
recurrent HF hospitalization
Number of participants that had an occurrence of HF hospitalization
Time frame: March, 2015 ~ May, 2021
Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score
Change from baseline to Month 6 and month 12 for the Kansas City Cardiomyopathy Questionnaire short form (KCCQ12) clinical summary score. KCCQ12 is a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: March, 2015 ~ May, 2021
Plan to share: Undecided — Individual participant data sharing plans will be discussed with other investigators
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Chang Gung Memorial Hospital