Clinical trial NCT06298825: S-ADHF：Sarcopenia in Patients With ADHF
Official title: Effect of Sarcopenia on Prognosis of Patients With Acute Decompensated Heart Failure: a Prospective, Multi-center, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Decompensated Heart Failure
Keywords: Acute decompensated heart failure
Sarcopenia
prognosis
mortality
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minmum of of 195 cases each for patients with and without sarcopenia

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 6 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 1 year and 2 year
measure: Cardiovascular mortality
timeFrame: 6 moths， 1year and 2 years
measure: All-cause hospitalisation
timeFrame: 6 moths， 1year and 2 years
measure: HF hospitalisation
timeFrame: 6 moths， 1year and 2 years
Other outcomes:
measure: The frequency and length of hospitalization of patient readmitted
timeFrame: 6 moths， 1year and 2 years
measure: Survival time from enrollment to death of deceased patients
timeFrame: 6 moths， 1year and 2 years
Locations:
city: Guangdong
country: China
facility: Huan Ma
Study officials:
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