Understanding skeletal muscle changes in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between skeletal muscle changes and physical performance in patients suffering from heart failure. It will involve enrolling 100 patients aged 60-80 years with severe heart failure (NYHA III-IV) and monitoring them over a period of 12-16 months. The study will assess how changes in muscle function correlate with cardiac function and overall prognosis, while also examining metabolic signatures in blood and satellite cells. The research is being conducted at Karolinska University Hospital in Sweden.

Why it matters

Who can join: the full rules

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.

Where it's running

• Karolinska University Hospital
  Stockholm, Stockholms Län, Sweden Recruiting

Study contacts

• Study coordinator: Thomas Gustafsson, MD, PhD
• Email: thomas.gustafsson@ki.se
• Phone: +46707415124

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.