Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-04-01
Study Completion Date
2026-06-01
Brief Summary
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This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure.
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Detailed Description
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Guangdong Provincial People's Hospital will be the lead center, with an additional 4 hospitals designated as satellite centers for the study. Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minimum of of 195 cases each for patients with and without sarcopenia The sympathetic nervous activity, psychosocial factors, quality of life, physical function and baseline physical activity will also be observed and recorded at baseline. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death. The primary clinical outcome is all-cause mortality at 6 months. Other clinical outcomes of interest include cardiovascular mortality, all-cause hospitalisation, HF hospitalisation, the frequency and length of hospitalization of patient readmitted and survival time from enrollment to death of deceased patients.
This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. S-ADHF will provide important information and evidence on the clinical aspects of sarcopenia in patients with ADHF, and will potentially and contribute to accurate risk stratification and optimal clinical management for patient with ADHF.
This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. S-ADHF will provide important information and evidence on the clinical aspects of sarcopenia in patients with ADHF, and will potentially and contribute to accurate risk stratification and optimal clinical management for patient with ADHF.
Conditions
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Acute Decompensated Heart Failure
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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sarcopenia
Acute decompensated heart failure with sarcopenia. Sarcopenia will be defined using the Asian Working Group for Sarcopenia (AWGS) criteria in the study. According to the guidelines, we can define participants as having sarcopenia when low muscle strength or physical performance coexisted with low skeletal muscle mass. We will define low muscle strength as handgrip strength \<26kg for men and \<18 kg for women, low physical performance as a walk speed of \<1.0m/s for both sexes. We can use bioelectrical impedance analysis to measure the appendicular skeletal muscle mass. The appendicular skeletal muscle mass index (ASMI) is calculated as the sum of muscle mass in the extremities divided by the height squared (kg/m2). The cut-off values of \<7.00 kg/m2 for men and \<5.70 kg/m2 for women will be used.
No interventions assigned to this group
Non-sarcopenia
Acute decompensated heart failure without sarcopenia
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years
2. At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
3. At least two of the signs of heart failure (HF):
Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.
Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).
Peripheral edema. Elevated B-type natriuretic peptide (\>100 pg/ml) or elevated N-Terminal Pro-Brain Natriuretic Peptide (\>300 pg/ml).
Willingness to provide informed consent and cooperate with the follow-up
2. At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
3. At least two of the signs of heart failure (HF):
Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.
Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).
Peripheral edema. Elevated B-type natriuretic peptide (\>100 pg/ml) or elevated N-Terminal Pro-Brain Natriuretic Peptide (\>300 pg/ml).
Willingness to provide informed consent and cooperate with the follow-up
Exclusion Criteria
1. Unable to understand and comply with protocol or to give informed consent
2. End-stage diseases other than heart failure, life expectancy \<1 year, such as malignant tumors
3. Current or planned participation in a clinical trial.
2. End-stage diseases other than heart failure, life expectancy \<1 year, such as malignant tumors
3. Current or planned participation in a clinical trial.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Huan Ma
Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Huan Ma
Guangdong, , China
Site Status
Countries
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China
Central Contacts
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Facility Contacts
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References
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Reference Type
DERIVED
Other Identifiers
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KY2024-148
Identifier Type: -
Identifier Source: org_study_id
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