Heart Failure - NYHA II - IV, Wide QRS Complex
Conditions
Brief summary
Cardiac Resynchronization Therapy (CRT) is a widely accepted treatment that has led to improved clinical outcomes for patients with refractory congestive heart failure (CHF), systolic dysfunction, and wide QRS duration. However, it requires implantation of an expensive device ($30,000) and about 1/3 of patients do not have clinical improvement. Inadequate amounts of LV dyssynchrony or suboptimal lead placement may limit clinical response. Dual-Source computed tomography (DSCT) allows for subtle detection during myocardial contraction for assessing LV dyssynchrony, and can also assess coronary venous anatomy and scar burden. Thus DSCT may be the ideal noninvasive modality to predict response to CRT.
Interventions
OTHERRandomization of Pre-knowledge of CT coronary venography
Sponsors
Brigham and Women's Hospital
Abbott Medical Devices
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years of age * Ability to provide informed consent * Planned CRT implantation * NYHA Functional Class II-IV heart failure * Echo Ejection Fraction less than or equal to 35% * QRS duration greater than or equal to 120 ms * Normal or mildly reduced kidney function (estimated serum creatinine less than or equal to 1.5 mg/dL or less than or equal to 1.3 mg/dL for diabetic subjects on metformin * For diabetic subjects on glucophage (metformin) they will be required to stop glucophage (metformin) for at least 48 hours after the administration of contrast.
Exclusion criteria
* Known allergy to iodine or iodinated contrast * Chronic persistent atrial fibrillation * Pregnancy or unknown pregnancy status * Subjects on glucophage (metformin) therapy that are unable or unwilling to discontinue therapy for 48 hours after CT scan * Known inadequate venous access for appropriate IV caliber placement * Iodinated contrast administration within the past 48 hours * Subjects who cannot hold their breath for 10-15 seconds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response to CRT | 6 months post implantation of CRT | The clinical response to CRT will be adjudicated by two experienced cardiologists taking into account left ventricular ejection fraction, NYHA functional class, and patient global assessment score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) | 2 years | MACE defined as composite endpoints of death, cardiac transplant, left ventricular assist device, and HF hospitalization |
| Secondary endpoints | 6 months | Change in NYHA Functional Class, Echo volumes and ejection fraction, Minnesota Quality of Life score, 6-minute walk distance, NT-proBNP levels, and hospitalization at 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implantation and fluoroscopy time and radiation exposure | During time of implant | Implantation time, fluoroscopy time, and radiation exposure |
| Agreement between CT venography and invasive coronary venography | within the CT venography and invasive coronary venography | — |
Countries
United States
Outcome results
None listed