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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02783716
• Other study ID #: 15-006402
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: July 20, 2021

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials