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S-ADHF:Sarcopenia in Patients With ADHF

Effect of Sarcopenia on Prognosis of Patients With Acute Decompensated Heart Failure: a Prospective, Multi-center, Observational Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06298825
Acronym
S-ADHF
Enrollment
500
Registered
2024-03-07
Start date
2024-04-01
Completion date
2026-06-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure

Keywords

Acute decompensated heart failure, Sarcopenia, prognosis, mortality, Kansas City Cardiomyopathy Questionnaire (KCCQ)

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.

Interventions

None listed

Sponsors

Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality6 monthsNumber of all-cause death 6 months from hospital discharge

Secondary

MeasureTime frameDescription
All-cause mortality1 year and 2 yearNumber of all-cause death 1year and 2 years from hospital discharge
Cardiovascular mortality6 moths, 1year and 2 yearsNumber of cardiovascular death 6 moths, 1year and 2 years from hospital discharge
All-cause hospitalisation6 moths, 1year and 2 yearsNumber of all-cause hospitalisation 6 moths, 1year and 2 years from hospital discharge
HF hospitalisation6 moths, 1year and 2 yearsNumber of HF hospitalisation 6 moths, 1year and 2 years from hospital discharge

Other

MeasureTime frameDescription
The frequency and length of hospitalization of patient readmitted6 moths, 1year and 2 yearsThe frequency and length of hospitalization of patient readmitted
Survival time from enrollment to death of deceased patients6 moths, 1year and 2 yearsSurvival time from enrollment to death of deceased patients

Countries

China

Contacts

Primary ContactHuan Ma, PhD
mahuandoctor@163.com+86 15078755932

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026