Heart FailureNCT05583513
Heart Failure Evaluation Study
An observational study of Heart Failure, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Heart failure (HF) is a highly prevalent conditions that impose a significant burden to the patients, the hospital and the healthcare system. In Hong Kong, HF was one of the commonest causes of hospitalization and death. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- MLHFQ (Minnesota Living with Heart Failure Questionnaire) and KCCQ (the Kansas City Cardiomyopathy Questionnaire)
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2022to 1 Oct 2023
- How long will I take part?
- 1 Year
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is base on the primary objective
Who may be able to join
- 1. Subject age >18 receiving management at the Ambulatory Heart Failure Clinic
Who cannot join
- 1. Subject is unable or unwilling to provide written consent prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Progression of Disease and Health-related Quality of Life in Ambulatory Heart Failure Patients: A Local Clinic-based Registry
Heart failure (HF) is a highly prevalent conditions that impose a significant burden to the patients, the hospital and the healthcare system. In Hong Kong, HF was one of the commonest causes of hospitalization and death. While HF with reduced ejection fraction (HFrEF) infer high mortality, HF with preserved ejection fraction (HFpEF) can be equally debilitating with similar hospital readmission rate and decline in functional status. Despite recent advancement and approval of novel pharmacologic agents and device therapies to treat HF, HF remains difficult to manage, with increased mortality and frequent hospitalization. HF is characterized by a gradual progression with intervals of exacerbation that often necessitating frequent re-admission. These readmissions are common with up to 1 quarter of patients readmitting within 30 days and half within 6 months8. An ambulatory HF centre can serve both as a transition of care from inpatients to community setting and as a point-of-care for early HF exacerbation (HFE) to prevent recurrent HF hospitalization. This is a registry study aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the ambulatory HF clinic.
Read the detailed description
Patient population and study location All patients managed at the Prince of Wales Hospital Ambulatory Heart Failure clinic will be recruited into this registry. Patients' consent will be sought from either the patients or their legal guardian should the patients deemed incapable to consent. There are no exclusion criteria.
Collectable Data Patients' demographic information, clinical characteristic including co-morbidities and physical findings, medication records, laboratory parameter including basic blood test and cardiac enzymes which include NT-pro BNP level, imaging parameters including echocardiographic findings and other relevant cardiac imaging findings will be recorded at baseline and at every visit. Patients' functional class as measure by the New York Heart Association (NYHA) classification and their 6 minute walk test will be recorded at selected time point. Patient's Health-related Quality of Life will be measured using both the Minnesota Living with Heart Failure Questionaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) at selected time-point. The MLHFQ, a 21-item HF-specific questionnaire, was adopted to evaluate the quality of life of the study subjects with score ranging 0-105 and lower the scores the better QoL. The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL. All subjects will have the Chinese version of the questionnaire administered by research team at baseline, 3-month and 12-month.
Intervention Since this is a registry, no active intervention will be provided. Treatment of HF will be dictated by the responsible physician.
Duration This registry aim to follow patients for long term.
Analysis All statistical analysis will be performed using STATA version 15 software (College Station, TX, USA). Continuous variables were described by using descriptive statistics including means, medians, and SDs. Frequencies were used for categorical variables. The prevalence of use of each drug was expressed as the percentage of patients using the drug. Wilcoxon Signed Rank Test was performed to test for statistical significance of the differences in NYHA, KCCQ-12 and MLHFQ scores at 3-month and 12-month with respect to the baseline. Kaplan-Meier survival analysis will be performed for time to first hospital admission and death, with time censored at death or on last follow-date. The effect of clinical categories on time to first hospitalization was assessed using adjusted Cox proportional hazards models. Repeat hospitalization outcomes were examined using Cox regression analysis for recurrent events, accounting for the possibility of multiple readmissions occurring over time in the same patient. We treat death and hospitalization as separate competing events. The lifetime of the HF patient is defined to begin on the first registration to the clinic. The MLHFQ-21 and KCCQ-12 domain and summary scores were analysed as continuous variables and grouped scores categories for analysis.
- Conditions
- Heart Failure
- Being tested
- MLHFQ (Minnesota Living with Heart Failure Questionnaire), KCCQ (the Kansas City Cardiomyopathy Questionnaire)
- Keywords
- Heart failure, HF with reduced ejection fraction, HF with preserved ejection fraction, HF exacerbation, quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLHFQ (Minnesota Living with Heart Failure Questionnaire)Diagnostic test
The MLHFQ, a 21-item HF-specific questionnaire, was adopted to evaluate the quality of life of the study subjects with score ranging 0-105 and lower the scores the better QoL
KCCQ (the Kansas City Cardiomyopathy Questionnaire)Diagnostic test
The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Heart Failure | Not described Receives: Diagnostic Test: MLHFQ (Minnesota Living with Heart Failure Questionnaire); Diagnostic Test: KCCQ (the Kansas City Cardiomyopathy Questionnaire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rehospitalization
Measured: Change from time to first rehospitalization at 12-months
100 patient-year readmission rate
Measured: Change from 100 patient-year readmission rate at 12-months
Change in functional class as measured by NYHA class over times
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
No NYHA class listed or unable to determine.
Measured: Change from functional class as measured by NYHA class over times at 12-months
Change in QoL as measured by MLHFQ and KCCQ over times
The MLHFQ, a 21-item HF-specific questionnaire, was adopted to evaluate the quality of life of the study subjects with score ranging 0-105 and lower the scores the better QoL.
The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL.
Measured: Change from QoL as measured by MLHFQ over times at 12-months
Change in QoL as measured by KCCQ over times
The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL.
Measured: Change from QoL as measured by KCCQ over times at 12-months
Heart-failure related mortality
Measured: Change from Heart-failure related mortality at 12-months
Secondary outcomes (7)
Change in number of Participants With Abnormal Laboratory Values
Measured: Change from number of Participants With Abnormal Laboratory Values at 12-months
Change in patients' laboratory parameters
Measured: Change from patients' laboratory parameters at 12-months
Change from baseline in log-transformed NT-proBNP level over time
Measured: Change from baseline in log-transformed NT-proBNP level over time at 12-months
Change in 6MWT
Measured: Change from 6MWT at 12-months
Change of cardiovascular medications
Change of cardiovascular medications, including ACEI/ARB/ARNI, Beta-blockers, Calcium Channel Blockers, Diuretics, Aldosterone antagonist, antiplatelet, anticoagulation, anti-arrythmias, vasodilators, lipid-lowering agents, potassium supplements, SGLT2 inhibitors.
Measured: Change of cardiovascular medications at 12-months
Cardiovascular and All-cause mortality
Measured: Change from cardiovascular and All-cause mortality at 12-months
The costs of all services, medications and tests
The costs of all services, medications and tests as estimated with reference to the Hong Kong Government Gazette 2020 and Hong Kong Hospital Authority Drug Formulary 2020
Measured: Change from costs of all services, medications and tests at 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GuangMing Tan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583513
- Sponsor's protocol ID
- 2022.204
- Status last verified
- May 2025
- First submitted
- 26 Sep 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arora S, Lahewala S, Hassan Virk HU, Setareh-Shenas S, Patel P, Kumar V, Tripathi B, Shah H, Patel V, Gidwani U, Deshmukh A, Badheka A, Gopalan R. Etiologies, Trends, and Predictors of 30-Day Readmissions in Patients With Diastolic Heart Failure. Am J Cardiol. 2017 Aug 15;120(4):616-624. doi: 10.1016/j.amjcard.2017.05.028. Epub 2017 Jun 1.
PubMed 28648393Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
PubMed 33501848Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
PubMed 28785469Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.
PubMed 32150314McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Writing Committee; Maddox TM, Januzzi JL Jr, Allen LA, Breathett K, Butler J, Davis LL, Fonarow GC, Ibrahim NE, Lindenfeld J, Masoudi FA, Motiwala SR, Oliveros E, Patterson JH, Walsh MN, Wasserman A, Yancy CW, Youmans QR. 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2021 Feb 16;77(6):772-810. doi: 10.1016/j.jacc.2020.11.022. Epub 2021 Jan 11. No abstract available.
PubMed 33446410Chun S, Tu JV, Wijeysundera HC, Austin PC, Wang X, Levy D, Lee DS. Lifetime analysis of hospitalizations and survival of patients newly admitted with heart failure. Circ Heart Fail. 2012 Jul 1;5(4):414-21. doi: 10.1161/CIRCHEARTFAILURE.111.964791. Epub 2012 May 2.
PubMed 22556322Greene SJ, Mentz RJ, Felker GM. Outpatient Worsening Heart Failure as a Target for Therapy: A Review. JAMA Cardiol. 2018 Mar 1;3(3):252-259. doi: 10.1001/jamacardio.2017.5250.
PubMed 29387880DeVore AD, Allen LA, Eapen ZJ. Thinking Outside the Box: Treating Acute Heart Failure Outside the Hospital to Improve Care and Reduce Admissions. J Card Fail. 2015 Aug;21(8):667-73. doi: 10.1016/j.cardfail.2015.05.009. Epub 2015 May 22.
PubMed 26009012Zsilinszka R, Mentz RJ, DeVore AD, Eapen ZJ, Pang PS, Hernandez AF. Acute Heart Failure: Alternatives to Hospitalization. JACC Heart Fail. 2017 May;5(5):329-336. doi: 10.1016/j.jchf.2016.12.014. Epub 2017 Mar 8.
PubMed 28285117Hung YT, Cheung NT, Ip S, Fung H. Epidemiology of heart failure in Hong Kong, 1997. Hong Kong Med J. 2000 Jun;6(2):159-62.
PubMed 10895138Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
PubMed 10758967
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Progression of Disease and Health-related Quality of Life in Ambulatory Heart Failure Patients: A Local Clinic-based Registry
- ClinicalTrials.gov ID
- NCT05583513
- Acronym / sponsor ID
- 2022.204
- Conditions
- Heart Failure
- Keywords
- Heart failure, HF with reduced ejection fraction, HF with preserved ejection fraction, HF exacerbation, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 17 Oct 2022 (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.
Heart failure (HF) is a highly prevalent conditions that impose a significant burden to the patients, the hospital and the healthcare system. In Hong Kong, HF was one of the commonest causes of hospitalization and death. While HF with reduced ejection fraction (HFrEF) infer high mortality, HF with preserved ejection fraction (HFpEF) can be equally debilitating with similar hospital readmission rate and decline in functional status. Despite recent advancement and approval of novel pharmacologic agents and device therapies to treat HF, HF remains difficult to manage, with increased mortality and frequent hospitalization. HF is characterized by a gradual progression with intervals of exacerbation that often necessitating frequent re-admission. These readmissions are common with up to 1 quarter of patients readmitting within 30 days and half within 6 months8. An ambulatory HF centre can serve both as a transition of care from inpatients to community setting and as a point-of-care for early HF exacerbation (HFE) to prevent recurrent HF hospitalization. This is a registry study aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the ambulatory HF clinic.
Detailed description
Patient population and study location All patients managed at the Prince of Wales Hospital Ambulatory Heart Failure clinic will be recruited into this registry. Patients' consent will be sought from either the patients or their legal guardian should the patients deemed incapable to consent. There are no exclusion criteria.
Collectable Data Patients' demographic information, clinical characteristic including co-morbidities and physical findings, medication records, laboratory parameter including basic blood test and cardiac enzymes which include NT-pro BNP level, imaging parameters including echocardiographic findings and other relevant cardiac imaging findings will be recorded at baseline and at every visit. Patients' functional class as measure by the New York Heart Association (NYHA) classification and their 6 minute walk test will be recorded at selected time point. Patient's Health-related Quality of Life will be measured using both the Minnesota Living with Heart Failure Questionaire (MLHFQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) at selected time-point. The MLHFQ, a 21-item HF-specific questionnaire, was adopted to evaluate the quality of life of the study subjects with score ranging 0-105 and lower the scores the better QoL. The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL. All subjects will have the Chinese version of the questionnaire administered by research team at baseline, 3-month and 12-month.
Intervention Since this is a registry, no active intervention will be provided. Treatment of HF will be dictated by the responsible physician.
Duration This registry aim to follow patients for long term.
Analysis All statistical analysis will be performed using STATA version 15 software (College Station, TX, USA). Continuous variables were described by using descriptive statistics including means, medians, and SDs. Frequencies were used for categorical variables. The prevalence of use of each drug was expressed as the percentage of patients using the drug. Wilcoxon Signed Rank Test was performed to test for statistical significance of the differences in NYHA, KCCQ-12 and MLHFQ scores at 3-month and 12-month with respect to the baseline. Kaplan-Meier survival analysis will be performed for time to first hospital admission and death, with time censored at death or on last follow-date. The effect of clinical categories on time to first hospitalization was assessed using adjusted Cox proportional hazards models. Repeat hospitalization outcomes were examined using Cox regression analysis for recurrent events, accounting for the possibility of multiple readmissions occurring over time in the same patient. We treat death and hospitalization as separate competing events. The lifetime of the HF patient is defined to begin on the first registration to the clinic. The MLHFQ-21 and KCCQ-12 domain and summary scores were analysed as continuous variables and grouped scores categories for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Heart Failure | – | Diagnostic Test: MLHFQ (Minnesota Living with Heart Failure Questionnaire), Diagnostic Test: KCCQ (the Kansas City Cardiomyopathy Questionnaire) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is base on the primary objective
Key inclusion criteria (1 listed)
- 1. Subject age >18 receiving management at the Ambulatory Heart Failure Clinic
Key exclusion criteria (1 listed)
- 1. Subject is unable or unwilling to provide written consent prior to enrollment
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 |
|---|---|---|
| MLHFQ (Minnesota Living with Heart Failure Questionnaire)The MLHFQ, a 21-item HF-specific questionnaire, was adopted to evaluate the quality of life of the study subjects with score ranging 0-105 and lower the scores the better QoL | Diagnostic test | Ambulatory Heart Failure |
| KCCQ (the Kansas City Cardiomyopathy Questionnaire)The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL | Diagnostic test | Ambulatory Heart Failure |
Primary outcome
Time to first rehospitalization
Time frame: Change from time to first rehospitalization at 12-months
100 patient-year readmission rate
Time frame: Change from 100 patient-year readmission rate at 12-months
Change in functional class as measured by NYHA class over times
Time frame: Change from functional class as measured by NYHA class over times at 12-months
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. No NYHA class listed or unable to determine.
Change in QoL as measured by MLHFQ and KCCQ over times
Time frame: Change from QoL as measured by MLHFQ over times at 12-months
The MLHFQ, a 21-item HF-specific questionnaire, was adopted to evaluate the quality of life of the study subjects with score ranging 0-105 and lower the scores the better QoL. The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL.
Change in QoL as measured by KCCQ over times
Time frame: Change from QoL as measured by KCCQ over times at 12-months
The KCCQ, is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, with score ranging 1-100 and higher scores the better QoL.
Heart-failure related mortality
Time frame: Change from Heart-failure related mortality at 12-months
7 secondary outcomes
Change in number of Participants With Abnormal Laboratory Values
Time frame: Change from number of Participants With Abnormal Laboratory Values at 12-months
Change in patients' laboratory parameters
Time frame: Change from patients' laboratory parameters at 12-months
Change from baseline in log-transformed NT-proBNP level over time
Time frame: Change from baseline in log-transformed NT-proBNP level over time at 12-months
Change in 6MWT
Time frame: Change from 6MWT at 12-months
Change of cardiovascular medications
Time frame: Change of cardiovascular medications at 12-months
Cardiovascular and All-cause mortality
Time frame: Change from cardiovascular and All-cause mortality at 12-months
The costs of all services, medications and tests
Time frame: Change from costs of all services, medications and tests at 12-months
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 30 May 2025.
- Background: PubMed 28648393Arora S, Lahewala S, Hassan Virk HU, Setareh-Shenas S, Patel P, Kumar V, Tripathi B, Shah H, Patel V, Gidwani U, Deshmukh A, Badheka A, Gopalan R. Etiologies, Trends, and Predictors of 30-Day Readmissions in Patients With Diastolic Heart Failure. Am J Cardiol. 2017 Aug 15;120(4):616-624. doi: 10.1016/j.amjcard.2017.05.028. Epub 2017 Jun 1.
- Results publication: PubMed 33501848Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
- Results publication: PubMed 28785469Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
- Results publication: PubMed 32150314Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.
- Results publication: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Results publication: PubMed 33446410Writing Committee; Maddox TM, Januzzi JL Jr, Allen LA, Breathett K, Butler J, Davis LL, Fonarow GC, Ibrahim NE, Lindenfeld J, Masoudi FA, Motiwala SR, Oliveros E, Patterson JH, Walsh MN, Wasserman A, Yancy CW, Youmans QR. 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2021 Feb 16;77(6):772-810. doi: 10.1016/j.jacc.2020.11.022. Epub 2021 Jan 11. No abstract available.
- Results publication: PubMed 22556322Chun S, Tu JV, Wijeysundera HC, Austin PC, Wang X, Levy D, Lee DS. Lifetime analysis of hospitalizations and survival of patients newly admitted with heart failure. Circ Heart Fail. 2012 Jul 1;5(4):414-21. doi: 10.1161/CIRCHEARTFAILURE.111.964791. Epub 2012 May 2.
- Results publication: PubMed 29387880Greene SJ, Mentz RJ, Felker GM. Outpatient Worsening Heart Failure as a Target for Therapy: A Review. JAMA Cardiol. 2018 Mar 1;3(3):252-259. doi: 10.1001/jamacardio.2017.5250.
- Results publication: PubMed 26009012DeVore AD, Allen LA, Eapen ZJ. Thinking Outside the Box: Treating Acute Heart Failure Outside the Hospital to Improve Care and Reduce Admissions. J Card Fail. 2015 Aug;21(8):667-73. doi: 10.1016/j.cardfail.2015.05.009. Epub 2015 May 22.
- Results publication: PubMed 28285117Zsilinszka R, Mentz RJ, DeVore AD, Eapen ZJ, Pang PS, Hernandez AF. Acute Heart Failure: Alternatives to Hospitalization. JACC Heart Fail. 2017 May;5(5):329-336. doi: 10.1016/j.jchf.2016.12.014. Epub 2017 Mar 8.
- Results publication: PubMed 10895138Hung YT, Cheung NT, Ip S, Fung H. Epidemiology of heart failure in Hong Kong, 1997. Hong Kong Med J. 2000 Jun;6(2):159-62.
- Results publication: PubMed 10758967Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
- HA Statistical ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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 30 May 2025. 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 Hong Kong. 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?
Time to first rehospitalization (time frame: Change from time to first rehospitalization at 12-months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05583513, which also lists 12 linked publications.
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 30 May 2025.