Heart Failure Evaluation Study

May 26, 2025 updated by: GuangMing Tan, Chinese University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Shatin
      • Hong Kong, Shatin, Hong Kong, 0000
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population is base on the primary objective

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ambulatory Heart Failure
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
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first rehospitalization
Time Frame: Change from time to first rehospitalization at 12-months
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 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 from functional class as measured by NYHA class over times at 12-months
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 from QoL as measured by MLHFQ over times at 12-months
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.
Change from QoL as measured by KCCQ over times at 12-months
Heart-failure related mortality
Time Frame: Change from Heart-failure related mortality at 12-months
Change from Heart-failure related mortality at 12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of Participants With Abnormal Laboratory Values
Time Frame: Change from number of Participants With Abnormal Laboratory Values at 12-months
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 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 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 from 6MWT at 12-months
Change of cardiovascular medications
Time Frame: Change of cardiovascular medications at 12-months
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
Cardiovascular and All-cause mortality
Time Frame: Change from cardiovascular and All-cause mortality at 12-months
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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