Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
NCT ID: NCT02783716
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
45 participants
INTERVENTIONAL
2016-05-31
2021-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Cardiac Resynchronization Therapy (CRT) Group
Participants undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue
Subcutaneous adipose tissue collection
During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest
Peripheral arterial tonometry (PAT)
Non-invasive testing for blood vessel function. Specially designed finger probes placed on the middle finger of each hand. Pulsatile volume changes of the distal digit inducing pressure alterations in the finger cuff will be sensed by pressure transducers and recorded. Endothelial function will be measured via a reactive hyperemia (RH)-PAT index (RHI)
Control Group
Participants undergoing device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue
Subcutaneous adipose tissue collection
During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest
Peripheral arterial tonometry (PAT)
Non-invasive testing for blood vessel function. Specially designed finger probes placed on the middle finger of each hand. Pulsatile volume changes of the distal digit inducing pressure alterations in the finger cuff will be sensed by pressure transducers and recorded. Endothelial function will be measured via a reactive hyperemia (RH)-PAT index (RHI)
Interventions
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Subcutaneous adipose tissue collection
During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest
Peripheral arterial tonometry (PAT)
Non-invasive testing for blood vessel function. Specially designed finger probes placed on the middle finger of each hand. Pulsatile volume changes of the distal digit inducing pressure alterations in the finger cuff will be sensed by pressure transducers and recorded. Endothelial function will be measured via a reactive hyperemia (RH)-PAT index (RHI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Hon-Chi Lee, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Hon-Chi Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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15-006402
Identifier Type: -
Identifier Source: org_study_id
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