Heart Failure, SystolicNCT05726565
Impact of Cardiac Rehabilitation on Acute Heart Failure Patients With Cognitive Impairment
An observational study of Heart Failure, Systolic and Morality, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Systolic, Morality, Cognitive Impairment
- What is being tested?
- multidisciplinary cardiac rehabilitation
- How many people
- 247 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2015to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF <=40%) and discharged alive from the hospital.
- Completed cognitive and psychological functional assessment.
- Aged >= 20 years of age, male or female.
- Received heart failure disease management coordinated by an HF specialist nurse as described before.
Who cannot join
- Estimated survival time < 6 months.
- Long-term bedridden for more than 3 months.
- Terminal heart status. 4. Cannot cooperate with all functional studies.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital Heart Failure Center
Kaohsiung City, 83341
About this study
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.
Read the detailed description
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.)
- Conditions
- Heart Failure, Systolic, Morality, Cognitive Impairment
- Being tested
- multidisciplinary cardiac rehabilitation
- Keywords
- acute heart failure, cognitive screening, cardiac rehabilitation, cardiopulmonary exercise test, adverse outcomes
- Medical subject headings
- Heart Failure, Systolic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary cardiac rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LNNB-S >=10 | 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. Receives: Other: multidisciplinary cardiac rehabilitation | |
| LNNB-S <10 | 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. Receives: Other: multidisciplinary cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: March, 2015 ~ May, 2021
Secondary outcomes (3)
all-cause mortality
Number of participants that had occurrence of the mortality which is defined as all-cause mortality
Measured: March, 2015 ~ May, 2021
recurrent HF hospitalization
Number of participants that had an occurrence of HF hospitalization
Measured: 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.
Measured: March, 2015 ~ May, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Mar 2015
- Primary completion30 Mar 2021
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726565
- Sponsor's protocol ID
- 202200636B0
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing plans will be discussed with other investigators
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiac Rehabilitation on Acute Heart Failure Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05726565
- Acronym / sponsor ID
- 202200636B0
- Conditions
- Heart Failure, Systolic, Morality, Cognitive Impairment
- Keywords
- acute heart failure, cognitive screening, cardiac rehabilitation, cardiopulmonary exercise test, adverse outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNNB-S >=10 | – | Other: multidisciplinary cardiac rehabilitationAs 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. |
| LNNB-S <10 | – | Other: multidisciplinary cardiac rehabilitationAs 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF <=40%) and discharged alive from the hospital.
- Completed cognitive and psychological functional assessment.
- Aged >= 20 years of age, male or female.
- Received heart failure disease management coordinated by an HF specialist nurse as described before.
Key exclusion criteria (3 listed)
- Estimated survival time < 6 months.
- Long-term bedridden for more than 3 months.
- Terminal heart status. 4. Cannot cooperate with all functional studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary cardiac rehabilitationA 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. | Other | LNNB-S <10, LNNB-S >=10 |
Primary outcome
composite of all-cause mortality or HF hospitalization
Time frame: March, 2015 ~ May, 2021
Number of participants that had an occurrence of the mortality which is defined as all-cause mortality or occurrence of HF hospitalization
3 secondary outcomes
all-cause mortality
Time frame: March, 2015 ~ May, 2021
recurrent 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
Time frame: March, 2015 ~ May, 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing plans will be discussed with other investigators
Related trials for Heart Failure, Systolic
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic and Morality, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of all-cause mortality or HF hospitalization (time frame: March, 2015 ~ May, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.