Heart Failure Evaluation Study

Heart Failure Clinical Trial

Official title:

Evaluation of the Progression of Disease and Health-related Quality of Life in Ambulatory Heart Failure Patients: A Local Clinic-based Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05583513
• Other study ID #: 2022.204
• Status: Enrolling by invitation
• Start date: October 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Subject age >18 receiving management at the Ambulatory Heart Failure Clinic

Exclusion Criteria:

1. Subject is unable or unwilling to provide written consent prior to enrollment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• 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
• 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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

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. — View Citation

Chun 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 20 — View Citation

DeVore 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. Review. — View Citation

Green 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. — View Citation

Greene 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. — View Citation

Hung 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. — View Citation

McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm 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 — View Citation

Reddy 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, an — View Citation

Savarese 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. — View Citation

Virani 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, — View Citation

Writing 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 Exper — View Citation

Zsilinszka 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first rehospitalization		Change from time to first rehospitalization at 12-months
Primary	100 patient-year readmission rate		Change from 100 patient-year readmission rate at 12-months
Primary	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.	Change from functional class as measured by NYHA class over times at 12-months
Primary	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.	Change from QoL as measured by MLHFQ over times at 12-months
Primary	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.	Change from QoL as measured by KCCQ over times at 12-months
Primary	Heart-failure related mortality		Change from Heart-failure related mortality at 12-months
Secondary	Change in number of Participants With Abnormal Laboratory Values		Change from number of Participants With Abnormal Laboratory Values at 12-months
Secondary	Change in patients' laboratory parameters		Change from patients' laboratory parameters at 12-months
Secondary	Change from baseline in log-transformed NT-proBNP level over time		Change from baseline in log-transformed NT-proBNP level over time at 12-months
Secondary	Change in 6MWT		Change from 6MWT at 12-months
Secondary	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.	Change of cardiovascular medications at 12-months
Secondary	Cardiovascular and All-cause mortality		Change from cardiovascular and All-cause mortality at 12-months
Secondary	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	Change from costs of all services, medications and tests at 12-months

External Links

•   HA Statistical Report