Metabolic Mapping and Cardiac Resynchronization

• ClinicalTrials.gov Identifier: NCT03420833
• Recruitment Status: Recruiting
• First Posted: February 5, 2018
• Last Update Posted: December 16, 2022
• Sponsor: Yong-Mei Cha
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Biotronik SE & Co. KG
• Information provided by (Responsible Party): Yong-Mei Cha, Mayo Clinic

Tracking Information

• First Submitted Date: January 29, 2018
• First Posted Date: February 5, 2018
• Last Update Posted Date: December 16, 2022
• Actual Study Start Date: August 20, 2018
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 29, 2018)

• Change in Left Ventricle End-Systolic Volume Index (LVESVI) [ Time Frame: baseline, approximately 12 months ]
  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 [ Time Frame: baseline, approximately 12 months ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 29, 2018)

• Number of Subjects Admitted to the Hospital for Heart Failure [ Time Frame: Approximately 12 months ]
• Number of Subjects Whose N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Increases by 30% [ Time Frame: Approximately 12 months ]
  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 [ Time Frame: Approximately 12 months ]
  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% [ Time Frame: Approximately 12 months ]
  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 [ Time Frame: Approximately 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Metabolic Mapping and Cardiac Resynchronization
• Official Title: Metabolic Mapping and Cardiac Resynchronization (Aim 1)
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Single-center, randomized cross-over study

Masking: Double (Participant, Investigator)
Masking Description:

Participants randomly assigned to have CRT-ON or OFF. At 6 months, participant CRT function will be crossed over.

Primary Purpose: Basic Science

• Condition: Heart Failure

Intervention

Device: Cardiac resynchronization therapy pacemaker (CRT-P)

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.

Other Name: BIOTRONIK Evia HF-T

Study Arms

• Experimental: CRT-On first, then CRT-Off
  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.
  Intervention: Device: Cardiac resynchronization therapy pacemaker (CRT-P)
• Experimental: CRT-Off first, then CRT-On
  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: Device: Cardiac resynchronization therapy pacemaker (CRT-P)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 29, 2018): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Brian Liddell; (507) 255-0774; Liddell.Brian@mayo.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03420833
• Other Study ID Numbers: 17-003359; 1R01HL134864-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Yong-Mei Cha, Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Yong-Mei Cha
• Original Study Sponsor: Same as current

Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)
• Biotronik SE & Co. KG

Investigators

• Principal Investigator: Yong-Mei Cha, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: December 2022