CHANges iN skEletal muscLe in Heart Failure

Heart Failure Clinical Trial

— Channel-HF  

Official title:

Changes in Skeletal Muscle Over Time in Severe Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03401151
• Other study ID #: Channel-HF KI
• Status: Recruiting
• Start date: February 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: Thomas Gustafsson, MD, PhD
• Phone: +46707415124
• Email: thomas.gustafsson[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion criteria:

• Signed informed consent

• 60-80 years old upon inclusion

• Chronic heart failure = 45 days.

• Left ventricular ejection fraction = 35%.

• NYHA III-IV

• Receiving medical management with optimal doses of betablockers, acetylcholinesterase (ACE)-inhibitors or angiotensin II receptor blockers (ARB), and mineral receptor antagonists (MRA) for at least 30 days if tolerated.

Exclusion criteria:

• Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 "crash and burn"

• On-going mechanical circulatory support.

• Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.

• Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance

• Condition, other than heart failure, requiring end-of-life care within <6 months in time or where the risk of death within <2 years is considered to be imminent.

• Participation in studies that resulted in departure from normal treatment routine or invasive investigations within <6 months back in time.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm	Stockholms Län

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic signature of muscle, messenger RNA (mRNA) gene expression	Metabolomics profile using nuclear magnetic resonance (NMR)	Change from baseline metabolic signature at 24 months
Primary	Metabolic signature of muscle, messenger RNA (mRNA) gene	Metabolomics profile using liquid chromatography-high-resolution mass spectrometry (LC-HRMS)	Change from baseline metabolic signature at 24 months
Secondary	Metabolic signature of blood, mRNA gene expression	Metabolomics profile using NMR	Change from baseline metabolic signature at 24 months
Secondary	Metabolic signature of blood, mRNA gene expression	Metabolomics profile using LC-HRMS	Change from baseline metabolic signature at 24 months
Secondary	Metabolic signature of satellite cells, mRNA gene expression	Metabolomics profile using NMR	Change from baseline metabolic signature at 24 months
Secondary	Metabolic signature of satellite cells, mRNA gene expression	Metabolomics profile using LC-HRMS	Change from baseline metabolic signature at 24 months
Secondary	Expression levels of targeted genes using transcriptomics	Choice of genes based on results obtained by metabolomics approaches	Change from baseline metabolic signature at 24 months