CHANges iN skEletal muscLe in Heart Failure

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT03401151
• Lead Sponsor: Karolinska Institutet

Brief Summary

The mechanisms behind heart failure are largely unknown. Despite an increasing arsenal of pharmacological therapies, cardiovascular disease is still the most common cause of death in the western world, which demonstrates a pronounced need for more patient-related mechanistic research. Cachexia and limited exercise capacity are the symptoms that best match prediction of heart failure, both of which are symptoms involving a dysfunctional skeletal muscle. An increased understanding of the mechanisms and signaling pathways connects the failure heart with skeletal muscle dysfunction is likely to lead both to discoveries of prognostic factors and possible therapeutic options.

The study is a prospective, non-blinded, study. The study will consist of the assignment of patients with heart failure, New York Heart Association (NYHA) III-IV, 60-80 years old. One hundred (100) patients will be enrolled in this study.

Detailed Description

The primary objective is to investigate how changes in the skeletal muscle coincide with changes in physical performance, cardiac function, and prognosis in patients with heart failure, and changes over time. Therefore, the investigators will investigate patients with severe heart failure at 'baseline' and on a second follow-up occasion after 12-16 months.

The secondary and tertiary objective is to investigate how changes in the metabolic signature of blood and satellite cells coincide with changes in physical performance, cardiac function, and prognosis in patients with heart failure, and changes over time. Patient recruitment is expected to occur over 36 months.

The study will be conducted in Sweden at Karolinska University Hospital, Huddinge.

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-17
• Study Start: 2018-02-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-04
• Last Update Posted: 2020-10-06
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic signature of muscle, messenger RNA (mRNA) gene expression	Change from baseline metabolic signature at 24 months	Metabolomics profile using nuclear magnetic resonance (NMR)
Metabolic signature of muscle, messenger RNA (mRNA) gene	Change from baseline metabolic signature at 24 months	Metabolomics profile using liquid chromatography-high-resolution mass spectrometry (LC-HRMS)

Secondary Outcome Measures

Name	Time	Method
Expression levels of targeted genes using transcriptomics	Change from baseline metabolic signature at 24 months	Choice of genes based on results obtained by metabolomics approaches
Metabolic signature of blood, mRNA gene expression	Change from baseline metabolic signature at 24 months	Metabolomics profile using LC-HRMS
Metabolic signature of satellite cells, mRNA gene expression	Change from baseline metabolic signature at 24 months	Metabolomics profile using LC-HRMS

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Stockholms Län, Sweden