S-ADHF：Sarcopenia in Patients With ADHF

NCT06298825 | Not Yet Recruiting

• 1 other identifier: KY2024-148
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Decompensated Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Number of all-cause death 6 months from hospital discharge

  6 months

Secondary Outcomes (4)

• All-cause mortality

  1 year and 2 year

• Cardiovascular mortality

  6 moths， 1year and 2 years

• All-cause hospitalisation

  6 moths， 1year and 2 years

• HF hospitalisation

  6 moths， 1year and 2 years

Other Outcomes (2)

• The frequency and length of hospitalization of patient readmitted

  6 moths， 1year and 2 years

• Survival time from enrollment to death of deceased patients

  6 moths， 1year and 2 years

Study Arms (2)

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.

Non-sarcopenia

Acute decompensated heart failure without sarcopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age ≥18 years
• At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
• 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

You may not qualify if:

• Unable to understand and comply with protocol or to give informed consent
• End-stage diseases other than heart failure, life expectancy \<1 year, such as malignant tumors
• Current or planned participation in a clinical trial.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Huan Ma

Guangdong, China

Location

Related Publications (43)

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MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Huan Ma, PhD

CONTACT

+86 15078755932; mahuandoctor@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: June 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)