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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06298825
Other study ID # KY2024-148
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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 allClick 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
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