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

Primary Purpose

Heart Failure

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Subcutaneous adipose tissue collection

Peripheral arterial tonometry (PAT)

About this trial

This is an interventional health services research trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Cardiac Resynchronization Therapy (CRT) Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02783716

First Posted

May 20, 2016

Last Updated

January 13, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02783716

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Due to COVID and staffing issues study was terminated

Study Start Date

May 2016 (undefined)

Primary Completion Date

July 20, 2021 (Actual)

Study Completion Date

July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardiac Resynchronization Therapy (CRT) Group

Arm Type

Active Comparator

Arm Description

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Subcutaneous adipose tissue collection

Intervention Description

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

Diagnostic Test

Intervention Name(s)

Peripheral arterial tonometry (PAT)

Other Intervention Name(s)

EndoPAT

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change in vascular endothelial function

Description

Vascular endothelial function will be measured using peripheral arterial tonometry as the reactive hyperemia index (RHI) at baseline and at 3 months.

Time Frame

baseline, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hon-Chi Lee, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55901

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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