CHANges iN skEletal muscLe in Heart Failure

NCT03401151 | Unknown

• 1 other identifier: Channel-HF KI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; Skeletal muscle; Exercise capacity; Lung function; Gene expression

Outcome Measures

Primary Outcomes (2)

• Metabolic signature of muscle, messenger RNA (mRNA) gene expression

  Metabolomics profile using nuclear magnetic resonance (NMR)

  Change from baseline metabolic signature at 24 months

• 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 Outcomes (5)

• Metabolic signature of blood, mRNA gene expression

  Change from baseline metabolic signature at 24 months

• Metabolic signature of blood, mRNA gene expression

  Change from baseline metabolic signature at 24 months

• Metabolic signature of satellite cells, mRNA gene expression

  Change from baseline metabolic signature at 24 months

• Metabolic signature of satellite cells, mRNA gene expression

  Change from baseline metabolic signature at 24 months

• Expression levels of targeted genes using transcriptomics

  Change from baseline metabolic signature at 24 months

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe heart failure

You may qualify if:

• Signed informed consent
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 144 86, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, muscle biopsies Initial examination and sampling: A) Blood sampling B) Ecocardiographic examination, C) Maximal working test including oxygen uptake D) Measurement of arm and leg strength using so-called Biodex E) Pulse, blood pressure and cardiac output volume measurement F) Measurement of muscle mass using CT G) Muscle biopsy in local anesthesia taken from one leg's vastus lateralis H) Daily physical activity measured with an accelerometer (pedometer) I) Measurement of lung function using standard spirometry J) Cardiac examination with MR in non-pacemaker subjects 24 months after the first sampling, the persons will be asked to re-examine the same examination procedures.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Matti Sällberg, professor

  Karolinska Institutet

  STUDY CHAIR

Central Study Contacts

Thomas Gustafsson, MD, PhD

CONTACT

+46707415124; thomas.gustafsson@ki.se

Eric Rullman, MD, PhD

CONTACT

+46739708096; eric.rullman@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: January 17, 2018
• Study Start: February 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

SE (1)