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

NCT ID: NCT02783716

Last Updated: 2023-01-18

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2021-07-20

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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Subcutaneous adipose tissue collection

Intervention Type PROCEDURE

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)

Intervention Type DIAGNOSTIC_TEST

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

Group Type ACTIVE_COMPARATOR

Subcutaneous adipose tissue collection

Intervention Type PROCEDURE

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)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type PROCEDURE

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)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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EndoPAT

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Hon-Chi Lee, M.D., Ph.D.

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

Related Links

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Other Identifiers

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15-006402

Identifier Type: -

Identifier Source: org_study_id

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