S-ADHF：Sarcopenia in Patients With ADHF (S-ADHF)

March 8, 2024 updated by: Huan Ma, Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 6 months
Number of all-cause death 6 months from hospital discharge
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 1 year and 2 year
Number of all-cause death 1year and 2 years from hospital discharge
1 year and 2 year
Cardiovascular mortality
Time Frame: 6 moths， 1year and 2 years
Number of cardiovascular death 6 moths， 1year and 2 years from hospital discharge
6 moths， 1year and 2 years
All-cause hospitalisation
Time Frame: 6 moths， 1year and 2 years
Number of all-cause hospitalisation 6 moths， 1year and 2 years from hospital discharge
6 moths， 1year and 2 years
HF hospitalisation
Time Frame: 6 moths， 1year and 2 years
Number of HF hospitalisation 6 moths， 1year and 2 years from hospital discharge
6 moths， 1year and 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency and length of hospitalization of patient readmitted
Time Frame: 6 moths， 1year and 2 years
The frequency and length of hospitalization of patient readmitted
6 moths， 1year and 2 years
Survival time from enrollment to death of deceased patients
Time Frame: 6 moths， 1year and 2 years
Survival time from enrollment to death of deceased patients
6 moths， 1year and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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