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

NCT05498584 | Recruiting DMC

• 1 other identifier: 202002486B0A3
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; With Decompensation

Keywords

heart failure; cardiac fibrosis; cardiac rehabilitation; endothelial function; cardiopulmonary exercise test; cardiac MRI

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

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

  up to 36 months

Secondary Outcomes (3)

• HF readmission

  up to 12 months

• enothelial function improvement

  up to 6 months

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

  Baseline, Month 6 , Month 12]

Study Arms (1)

Post-acute systolic heart failure patients

Patients who received at least one exercise training section within 3 months of acute heart failure discharge are placed in the CR group. Patients will receive a multi-disciplinary disease management program by a qualified HF nursing specialist. A board-certified physiatrist prescribes moderate continuous training according to a cardiopulmonary exercise test.

Behavioral: exercise based cardiac rehabilitation

Interventions

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.

Post-acute systolic heart failure patients

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Ventilator dependent
• Terminal heart status
• Family rejects to participate in this project
• Primary severe valvular heart disease

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, 83341, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples with less than 10 ml volume were collected from patients who had fasted overnight. The samples were then centrifuged and stored at -70°C until they were assayed to determine serum LOXL2 levels and other biomarkers. ELISA kits provided by the manufacturer (R\&D Systems, Abingdon, UK) were used for analysis, following their instructions. The absorbance at 450 nm was measured using a microplate reader, and standard curves were utilized to determine cytokine levels.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Shyh-Ming Che, MD

  Chang Gung Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsin-Yen Tsai

CONTACT

+886929610850; milktea588@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: August 25, 2022
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 16, 2024

Record last verified: 2023-12

Locations

TW (1)