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Effect of Cardiac Resynchronization Therapy (CRT) on Skeletal Muscle Histology, Neuroendocrine Activation and Inflammatory Response

This study has been completed.
Sponsor:
Collaborators:
University of Tromso
University of Oslo
The Royal Norwegian Ministry of Health
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01019915
First received: November 23, 2009
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Skeletal Muscle Changes After Crt
Device: CRT
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Cardiac Resynchronization Therapy on Skeletal Muscle Histology, Neuroendocrine Activation and Inflammatory Response

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • capillary density [ Time Frame: finnished ] [ Designated as safety issue: No ]
    To assess if CRT improves skeletal muscle cappillary density


Enrollment: 21
Study Start Date: January 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Heart failure patients. Intervention CRT
CRT implantation in heart failure. Effect of intervention after 6 months of treatment.
Device: CRT
Insertion of CRT in patients with left bundle branch block. Assessment of skeletal muscle and infalmmatory profile

Detailed Description:

Congestive heart failure (CHF) is the most common hospital discharge diagnosis in elderly patients . Fatigue and dyspnea with exercise intolerance and a poor quality of life are the main characteristics of this syndrome , and it is associated with substantial mortality and morbidity , .

Although the systolic dysfunction has been recognized as the primum movens of CHF, it is now generally accepted that the progression of the syndrome is not solely related to the pump failure.

The neuro-endocrine model has reached a wide consensus as one of the basic mechanisms for progressive heart failure based on the good results obtained by ACE-inhibitor therapy . A decade ago the cytokine model was added to explain the syndrome of heart failure . The cytokines are highly potent endogenous peptides produced by different cell types . Elevated levels might be markers for cardiac cachexia, but they may also play an important role in the mechanism of CHF progression . Subsequently, the muscle hypothesis was proposed as an explanation for the deconditioning in CHF patients . In skeletal muscle from healthy individuals there is a balanced distribution between type I fibres (aerobic), type IIA fibres (both aerobic and anaerobic) and type IIB fibres (mostly anaerobic). In CHF a shift to type II fibres and a reduced capillary density as well as a reduced cytochrome oxidase activity is observed, but the mechanisms leading to such a shift have not been clarified . Deconditioning may be an important factor aggravating the underlying pathophysiology in CHF and exercise training has been shown to improve exercise performance and to reduce symptoms in this population . This is partly mediated by activation of the Protein PGC-1, a critical factor coordinating the activation of metabolic genes required for substrate utilization and mitochondrial biogenesis . The increase in this enzyme has been highly correlated to increase in peak VO2 after a aerobic interval training program in heart failure .

One would expect that an improvement in exercise performance following improvement in central hemodynamics with cardiac resynchronization therapy (CRT) would be associated with improved muscular blood flow and energy metabolism. However, so far no reports have been published on the skeletal muscle response to CRT. The purpose of this study was to evaluate the effect of 6 months CRT pacing on skeletal muscle histology and mitochondrial mass and the association of these changes to alterations in functional capacity as measured with peak VO2. Moreover, we also sought to assess the relationship between changes in skeletal muscle and alterations in the inflammatory response in serum and in skeletal muscle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart failure, left bundle branch block

Exclusion Criteria:

  • serious comorbidity including systemic inflammatory disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019915

Locations
Norway
Stavanger University Hospital
Stavanger, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
University of Tromso
University of Oslo
The Royal Norwegian Ministry of Health
  More Information

No publications provided

Responsible Party: Stein Tore Nilsen, Research Director, Stavanger University Hospital
ClinicalTrials.gov Identifier: NCT01019915     History of Changes
Other Study ID Numbers: CRT-AIL-SUS 2009
Study First Received: November 23, 2009
Last Updated: June 20, 2011
Health Authority: Norway: Norwegian Social Science Data Services
Norway: Ethics Committee
Norway: Ministry of Health and Care Services

Keywords provided by Helse Stavanger HF:
CRT
heart failure
left bundle branch block
skeletal muscle
cytokines
VO2
pgc1alpha

ClinicalTrials.gov processed this record on November 24, 2014