S-ADHF：Sarcopenia in Patients With ADHF

Acute Decompensated Heart Failure Clinical Trial

— S-ADHF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298825
• Other study ID #: KY2024-148
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: January 2024
• Source: Guangdong Provincial People's Hospital
• Contact: Huan Ma, PhD
• Phone: +86 15078755932
• Email: mahuandoctor[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure
• Sarcopenia

Locations

Country	Name	City	State
China	Huan Ma	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The frequency and length of hospitalization of patient readmitted	The frequency and length of hospitalization of patient readmitted	6 moths, 1year and 2 years
Other	Survival time from enrollment to death of deceased patients	Survival time from enrollment to death of deceased patients	6 moths, 1year and 2 years
Primary	All-cause mortality	Number of all-cause death 6 months from hospital discharge	6 months
Secondary	All-cause mortality	Number of all-cause death 1year and 2 years from hospital discharge	1 year and 2 year
Secondary	Cardiovascular mortality	Number of cardiovascular death 6 moths, 1year and 2 years from hospital discharge	6 moths, 1year and 2 years
Secondary	All-cause hospitalisation	Number of all-cause hospitalisation 6 moths, 1year and 2 years from hospital discharge	6 moths, 1year and 2 years
Secondary	HF hospitalisation	Number of HF hospitalisation 6 moths, 1year and 2 years from hospital discharge	6 moths, 1year and 2 years