Effect of Cardiac Resynchronization Therapy (CRT) on Skeletal Muscle Histology, Neuroendocrine Activation and Inflammatory Response
1 other identifier
interventional
21
1 country
1
Brief Summary
Heart failure patients with left bundle branch block have a poor prognosis. Biventricular pacing which synchronize the heart pump action is associated with improved functional capacity. This study aims to evaluate the basic changes in skeletal muscle functioning after a period of biventricular pacing in 21 patients with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 23, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedJuly 28, 2015
June 1, 2011
5.8 years
November 23, 2009
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
capillary density
To assess if CRT improves skeletal muscle cappillary density
finnished
Study Arms (1)
Heart failure patients. Intervention CRT
OTHERCRT implantation in heart failure. Effect of intervention after 6 months of treatment.
Interventions
Insertion of CRT in patients with left bundle branch block. Assessment of skeletal muscle and infalmmatory profile
Eligibility Criteria
You may qualify if:
- Heart failure, left bundle branch block
You may not qualify if:
- serious comorbidity including systemic inflammatory disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFlead
- University of Tromsocollaborator
- University of Oslocollaborator
- The Royal Norwegian Ministry of Healthcollaborator
Study Sites (1)
Stavanger University Hospital
Stavanger, 4068, Norway
Related Publications (2)
Larsen AI, Valborgland T, Ogne C, Lindal S, Halvorsen B, Munk PS, Kvaloy JT, Aukrust P, Yndestad A. Plasma tumour necrosis factor correlates with mRNA expression of tumour necrosis factor and mitochondrial transcription factors in skeletal muscle in patients with chronic heart failure treated with cardiac resynchronization therapy: potential role in myopathy. Eur J Prev Cardiol. 2020 Dec;27(19):2362-2366. doi: 10.1177/2047487319855796. Epub 2019 Jun 8. No abstract available.
PMID: 31389718DERIVEDLarsen AI, Lindal S, Myreng K, Ogne C, Kvaloy JT, Munk PS, Aukrust P, Yndestad A, Dickstein K, Nilsen DW. Cardiac resynchronization therapy improves minute ventilation/carbon dioxide production slope and skeletal muscle capillary density without reversal of skeletal muscle pathology or inflammation. Europace. 2013 Jun;15(6):857-64. doi: 10.1093/europace/eus428. Epub 2013 Jan 15.
PMID: 23322010DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2009
First Posted
November 25, 2009
Study Start
January 1, 2004
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
July 28, 2015
Record last verified: 2011-06