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Metabolic Mapping and Cardiac Resynchronization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03420833
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : December 16, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Yong-Mei Cha, Mayo Clinic

Study Description
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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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: Cardiac resynchronization therapy pacemaker (CRT-P) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: Metabolic Mapping and Cardiac Resynchronization (Aim 1)
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Number of Subjects Admitted to the Hospital for Heart Failure [ Time Frame: Approximately 12 months ]
  2. 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.

  3. 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.

  4. 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.

  5. Number of Subjects Who Die in One Year [ Time Frame: Approximately 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420833


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

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brian Liddell    507-255-0774    Liddell.Brian@mayo.edu   
Principal Investigator: Yong-Mei Cha, MD         
Sponsors and Collaborators
Yong-Mei Cha
National Heart, Lung, and Blood Institute (NHLBI)
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Yong-Mei Cha, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Yong-Mei Cha, Sponsor Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03420833    
Other Study ID Numbers: 17-003359
1R01HL134864-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases