NCT01308138

Brief Summary

The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

February 2, 2011

Last Update Submit

August 19, 2015

Conditions

Keywords

Physical ActivitypathologyPhysical Deconditioning

Outcome Measures

Primary Outcomes (1)

  • Mitochondrial respiration

    Oxygraph (Strathkelvin)

    1 hour

Study Arms (3)

ExerciseTr

EXPERIMENTAL
Behavioral: Exercise training

Remote ischemic preconditioning group

EXPERIMENTAL
Procedure: remote ischemic preconditioning

Control patient group

NO INTERVENTION

Interventions

exercise training

ExerciseTr

remote ischemic preconditioning

Remote ischemic preconditioning group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing coronary heart surgery and heart transplantation

You may not qualify if:

  • myocardial infarction closer than 4 weeks to project start, serious valve defects, diabetes, unstable angina, uncontrolled hypertension, kidney failure (creatinin \> 140)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology, Medical Faculty

Trondheim, Sør-Trondelag, 7489, Norway

Location

Related Publications (2)

  • Slagsvold KH, Moreira JB, Rognmo O, Hoydal M, Bye A, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and activates pro-survival protein kinase Akt in the left ventricle during cardiac surgery: a randomized trial. Int J Cardiol. 2014 Dec 15;177(2):409-17. doi: 10.1016/j.ijcard.2014.09.206. Epub 2014 Oct 14.

  • Slagsvold KH, Rognmo O, Hoydal M, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and influences myocardial microRNA expression in atrial myocardium during coronary bypass surgery. Circ Res. 2014 Feb 28;114(5):851-9. doi: 10.1161/CIRCRESAHA.114.302751. Epub 2013 Dec 26.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Katrine Hordnes, MD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2011

First Posted

March 3, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations