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

NCT02783716 | Terminated

• 1 other identifier: 15-006402
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cardiac Resynchronization Therapy (CRT) Group

ACTIVE COMPARATOR

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; Diagnostic Test: Peripheral arterial tonometry (PAT)

Control Group

ACTIVE COMPARATOR

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; Diagnostic Test: Peripheral arterial tonometry (PAT)

Interventions

Subcutaneous adipose tissue collection PROCEDURE

During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest

Cardiac Resynchronization Therapy (CRT) Group; Control Group

Peripheral arterial tonometry (PAT) 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)

Also known as: EndoPAT

Cardiac Resynchronization Therapy (CRT) Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hon-Chi Lee, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 26, 2016
• Study Start: May 1, 2016
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)