Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure

Study Overview
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Brief Summary
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The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.

Official Title
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Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Subcutaneous adipose tissue collection
* Diagnostic Test: Peripheral arterial tonometry (PAT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CRT Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)<35%, Left Bundle Branch Block (LBBB)>120 ms, New York Heart Association (NYHA) Class II-III). Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks Exclusion Criteria: Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cardiac Resynchronization Therapy (CRT) Group<br>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 | Procedure: Subcutaneous adipose tissue collection<br>* During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest<br>Diagnostic Test: Peripheral arterial tonometry (PAT)<br>* 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)<br>* Other names: EndoPAT;|
| Active Comparator: Control Group<br>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 | Procedure: Subcutaneous adipose tissue collection<br>* During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest<br>Diagnostic Test: Peripheral arterial tonometry (PAT)<br>* 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)<br>* Other names: EndoPAT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular endothelial function | Vascular endothelial function will be measured using peripheral arterial tonometry as the reactive hyperemia index (RHI) at baseline and at 3 months. | baseline, 3 months |