Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02783716
Collaborator
(none)
75
1
2
79
0.9
Study Details
Study Description
Brief Summary
The goal of this study is to determine the role of vascular endothelial function in heart failure (HF) and the effect of cardiac resynchronization therapy (CRT) on endothelial and cardiac function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
Study Start Date
:
May 1, 2016
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cardiac Resynchronization Therapy (CRT) Participants will be undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure |
Device: Cardiac Resynchronization Therapy Implantation
An implanted cardiac resynchronization device is a medical device used in cardiac resynchronization therapy (CRT). It resynchronizes the contractions of the heart's ventricles by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently.
|
| Active Comparator: Control Group Participants will undergo device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block. |
Device: Implantable Cardioverter-defibrillator (ICD)
An implantable cardioverter-defibrillator (ICD) - a pager-sized device - is placed in the chest to reduce risk of dying if the lower chambers of the heart (ventricles) go into a dangerous rhythm and stop beating effectively
|
Outcome Measures
Primary Outcome Measures
- Change in vascular endothelial function [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55901 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Hon-Chi Lee, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Hon-Chi Lee, M.D., Ph.D.,
PI,
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02783716
Other Study ID Numbers:
- 15-006402
First Posted:
May 26, 2016
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms: