Metabolic Mapping and Cardiac Resynchronization

Yong-Mei Cha

Status: Completed

Conditions: Heart Failure

Treatments: Device: Cardiac resynchronization therapy pacemaker (CRT-P)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03420833

17-003359

1R01HL134864-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Left Ventricular Ejection Fraction (LVEF) 35%-50%
• New York Heart Association (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 angiotensin II type 1 (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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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82 participants in 2 patient groups

CRT-On first, then CRT-Off

Experimental group

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.

Treatment:

Device: Cardiac resynchronization therapy pacemaker (CRT-P)

CRT-Off first, then CRT-On

Experimental group

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.

Treatment:

Device: Cardiac resynchronization therapy pacemaker (CRT-P)