Understanding skeletal muscle changes in heart failure patients
Changes in Skeletal Muscle Over Time in Severe Heart Failure
This study is trying to see how changes in muscle strength affect the physical abilities of older adults with severe heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Stockholms Län) |
| Trial ID | NCT03401151 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60-80 years with chronic heart failure and a left ventricular ejection fraction of 35% or less.
Not a fit: Patients with severe chronic obstructive pulmonary disease or those requiring end-of-life care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic factors and therapeutic options for patients with heart failure.
How similar studies have performed: While the study addresses a critical area of heart failure research, similar studies have shown varying degrees of success in understanding muscle dysfunction in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stockholm, Stockholms Län
- Karolinska University Hospital — Stockholm, Stockholms Län, Sweden (Recruiting)
Study contacts
- Study coordinator: Thomas Gustafsson, MD, PhD
- Email: thomas.gustafsson@ki.se
- Phone: +46707415124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.