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Metabolic Mapping and Cardiac Resynchronization

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac resynchronization therapy pacemaker (CRT-P)
Sponsored by
Yong-Mei Cha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • LVEF 35%-50%
  • NYHA class I-II
  • QRS duration of ≥120ms
  • Left bundle branch block (LBBB)
  • Patient is able to receive a transvenous pectoral CRT implant
  • Patient is able to sign informed consent
  • Two echocardiograms are required to confirm a stable reduced LVEF
  • Patient is on optimal and stable medical therapy (ACE inhibitor or AT1 blocker, beta blocker, etc. over the last 6 months)

Exclusion Criteria:

  • Advanced comorbid conditions with life expectancy <1 year
  • Patient is <18 of years of age
  • Patient has a CRT device
  • Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
  • Unwilling or unable to return for required follow-up visits
  • Patient decides study participation is cost-prohibited

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CRT-On first, then CRT-Off

CRT-Off first, then CRT-On

Arm Description

Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period.

Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period.

Outcomes

Primary Outcome Measures

Change in Left Ventricle End-Systolic Volume Index (LVESVI)
LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Number of Subjects Not Experiencing Any System-Related Complications
This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection.

Secondary Outcome Measures

Number of Subjects Admitted to the Hospital for Heart Failure
Number of Subjects Whose N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Increases by 30%
The NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood.
Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater than 30 Seconds
In ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest.
Number of Subjects Who Experience a Decrease in Left Ventricular Ejection Fraction (LVEF) to ≤35%
LVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber.
Number of Subjects Who Die in One Year

Full Information

First Posted
January 29, 2018
Last Updated
December 15, 2022
Sponsor
Yong-Mei Cha
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT03420833
Brief Title
Metabolic Mapping and Cardiac Resynchronization
Official Title
Metabolic Mapping and Cardiac Resynchronization (Aim 1)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong-Mei Cha
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).

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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-center, randomized cross-over study
Masking
ParticipantInvestigator
Masking Description
Participants randomly assigned to have CRT-ON or OFF. At 6 months, participant CRT function will be crossed over.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRT-On first, then CRT-Off
Arm Type
Experimental
Arm Description
Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period.
Arm Title
CRT-Off first, then CRT-On
Arm Type
Experimental
Arm Description
Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period.
Intervention Type
Device
Intervention Name(s)
Cardiac resynchronization therapy pacemaker (CRT-P)
Other Intervention Name(s)
BIOTRONIK Evia HF-T
Intervention Description
A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.
Primary Outcome Measure Information:
Title
Change in Left Ventricle End-Systolic Volume Index (LVESVI)
Description
LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Time Frame
baseline, approximately 12 months
Title
Number of Subjects Not Experiencing Any System-Related Complications
Description
This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection.
Time Frame
baseline, approximately 12 months
Secondary Outcome Measure Information:
Title
Number of Subjects Admitted to the Hospital for Heart Failure
Time Frame
Approximately 12 months
Title
Number of Subjects Whose N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Increases by 30%
Description
The NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood.
Time Frame
Approximately 12 months
Title
Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater than 30 Seconds
Description
In ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest.
Time Frame
Approximately 12 months
Title
Number of Subjects Who Experience a Decrease in Left Ventricular Ejection Fraction (LVEF) to ≤35%
Description
LVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber.
Time Frame
Approximately 12 months
Title
Number of Subjects Who Die in One Year
Time Frame
Approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LVEF 35%-50% NYHA class I-II QRS duration of ≥120ms Left bundle branch block (LBBB) Patient is able to receive a transvenous pectoral CRT implant Patient is able to sign informed consent Two echocardiograms are required to confirm a stable reduced LVEF Patient is on optimal and stable medical therapy (ACE inhibitor or AT1 blocker, beta blocker, etc. over the last 6 months) Exclusion Criteria: Advanced comorbid conditions with life expectancy <1 year Patient is <18 of years of age Patient has a CRT device Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant Unwilling or unable to return for required follow-up visits Patient decides study participation is cost-prohibited
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Liddell
Phone
(507) 255-0774
Email
Liddell.Brian@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Mei Cha, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Liddell
Phone
507-255-0774
Email
Liddell.Brian@mayo.edu
First Name & Middle Initial & Last Name & Degree
Yong-Mei Cha, MD

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Metabolic Mapping and Cardiac Resynchronization

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