Targeting LOXL2 and Cardiac Fibrosis for Post-acute Heart Failure Treatment- A Prospective Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-100
SponsorChang Gung Memorial Hospital

About this trial

A previous study demonstrated that a multidisciplinary cardiac rehabilitation (CR) program was associated with reduced medium- to long-term all-cause mortality in a retrospective propensity score-matched study. The investigators will further investigate the predictors including LOXl2, cardiac MRI, and endothelial function that will benefit from a successful CR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must give written informed consent before any assessment is performed.

Inpatients >= 20 years of age, male or female.

Patients with a diagnosis of heart failure New York Heart Association (NYHA) class II-IV with BNP >=100 pg/mL or NT-porBNP >= 400 pg/mL ( >= 900 pg/mL if concomitant atrial fibrillation)

Left ventricular ejection fraction <= 40% by echocardiography or other methods

Disqualifiers

Estimated survival time < 6 months

Long-term bedridden for more than 3 months

Cannot tolerate exercise test due to muscular skeletal disorder.

Cannot cooperate all functional studies

Trial population

This study has a target enrollment of 126 HF patients admitted for worsening heart failure (HF) in 3 years, based on at least one symptom of HF and at least two signs of HF, and a change in medical treatment specifically targeting acute decompensated HF. We enroll those patients with reduced ejection fraction (LVEF \<=40%). Patients must be at least 20 years of age or greater, able to walk at the time of enrollment, and expected to be discharged to home.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • exercise based cardiac rehabilitation

    Behavioral

    The types of exercise are treadmill walking/walking-jogging/jogging, ergometer cycling, stair climbing, or elliptical machine training. The training intensity is gradually increased fortnightly to reach the targeted Borg's rate of perceived exertion (RPE) of 12-14. The training duration is 40 minutes, which included 5-10 minutes of warm-up and cool-down exercises. The training frequency is three sessions per week, with 36 sessions concluding a complete course.

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Post-acute systolic heart failure patients1 intervention

Trial outcomes

Primary outcomes

1

all-cause mortality

Number of Participants That Had First Occurrence of the All-cause mortality

Time frame
up to 36 months

Secondary outcomes

1

HF readmission

Number of participants that had first occurrence of the HF readmission.

Time frame
up to 12 months
2

enothelial function improvement

changes of FMD from baseline to 6 months

Time frame
up to 6 months
3

Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score

Change from baseline to Month 6 and month 12 for the Kansas City Cardiomyopathy Questionnaire short form (KCCQ12) clinical summary score. KCCQ12 is a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Time frame
Baseline, Month 6 , Month 12]

Other outcomes

Sponsors and contacts

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