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

January 13, 2023 updated by: Hon-Chi Lee, M.D., Ph.D., Mayo Clinic
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: 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
Diagnostic test: 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 Names:
  • EndoPAT
Active Comparator: 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
Procedure: 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
Diagnostic test: 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 Names:
  • EndoPAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vascular endothelial function
Time Frame: baseline, 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Hon-Chi Lee, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 20, 2021

Study Completion (Actual)

July 20, 2021

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-006402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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