Clinical trial NCT05583513: Heart Failure Evaluation 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
HF with reduced ejection fraction
HF with preserved ejection fraction
HF exacerbation
quality of life
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is base on the primary objective

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first rehospitalization
timeFrame: Change from time to first rehospitalization at 12-months
measure: 100 patient-year readmission rate
timeFrame: Change from 100 patient-year readmission rate at 12-months
measure: Change in functional class as measured by NYHA class over times
timeFrame: Change from functional class as measured by NYHA class over times at 12-months
measure: Change in QoL as measured by MLHFQ and KCCQ over times
timeFrame: Change from QoL as measured by MLHFQ over times at 12-months
measure: Change in QoL as measured by KCCQ over times
timeFrame: Change from QoL as measured by KCCQ over times at 12-months
measure: Heart-failure related mortality
timeFrame: Change from Heart-failure related mortality at 12-months
Secondary outcomes:
measure: Change in number of Participants With Abnormal Laboratory Values
timeFrame: Change from number of Participants With Abnormal Laboratory Values at 12-months
measure: Change in patients' laboratory parameters
timeFrame: Change from patients' laboratory parameters at 12-months
measure: Change from baseline in log-transformed NT-proBNP level over time
timeFrame: Change from baseline in log-transformed NT-proBNP level over time at 12-months
measure: Change in 6MWT
timeFrame: Change from 6MWT at 12-months
measure: Change of cardiovascular medications
timeFrame: Change of cardiovascular medications at 12-months
measure: Cardiovascular and All-cause mortality
timeFrame: Change from cardiovascular and All-cause mortality at 12-months
measure: The costs of all services, medications and tests
timeFrame: Change from costs of all services, medications and tests at 12-months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
References:
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