Status:
UNKNOWN
CHANges iN skEletal muscLe in Heart Failure
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Region Stockholm
Conditions:
Heart Failure
Eligibility:
All Genders
60-80 years
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...
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 ov...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03401151
Start Date
February 1 2018
End Date
December 31 2025
Last Update
October 6 2020
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 144 86