Heart Failure Evaluation Study

NCT05583513 | Completed

• 1 other identifier: 2022.204
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

Heart failure; HF with reduced ejection fraction; HF with preserved ejection fraction; HF exacerbation; quality of life

Outcome Measures

Primary Outcomes (6)

• Time to first rehospitalization

  Change from time to first rehospitalization at 12-months

• 100 patient-year readmission rate

  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.

  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.

  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.

  Change from QoL as measured by KCCQ over times at 12-months

• Heart-failure related mortality

  Change from Heart-failure related mortality at 12-months

Secondary Outcomes (7)

• Change in number of Participants With Abnormal Laboratory Values

  Change from number of Participants With Abnormal Laboratory Values at 12-months

• Change in patients' laboratory parameters

  Change from patients' laboratory parameters at 12-months

• 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

• Change in 6MWT

  Change from 6MWT at 12-months

• Change of cardiovascular medications

  Change of cardiovascular medications at 12-months

Study Arms (1)

Ambulatory Heart Failure

Diagnostic Test: MLHFQ (Minnesota Living with Heart Failure Questionnaire); Diagnostic Test: KCCQ (the Kansas City Cardiomyopathy Questionnaire)

Interventions

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

Ambulatory Heart Failure

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

Ambulatory Heart Failure

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is base on the primary objective

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

Location

Related 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.

  PMID: 28648393 BACKGROUND

• 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, 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.

  PMID: 33501848 RESULT

• 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.

  PMID: 28785469 RESULT

• 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, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.

  PMID: 32150314 RESULT

• McDonagh 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.

  PMID: 34447992 RESULT

• 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 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.

  PMID: 33446410 RESULT

• 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 2012 May 2.

  PMID: 22556322 RESULT

• 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.

  PMID: 29387880 RESULT

• 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.

  PMID: 26009012 RESULT

• 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.

  PMID: 28285117 RESULT

• 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.

  PMID: 10895138 RESULT

• 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. doi: 10.1016/s0735-1097(00)00531-3.

  PMID: 10758967 RESULT

Related Links

• HA Statistical Report

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 17, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

HK (1)