Trial Outcomes & Findings for Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure (NCT NCT03001674)

Results Overview

We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

24 hours

Results posted on

2017-05-31

Participant Flow

10 patients with advanced HF from 2014 to 2015 at Tufts Medical Center referred for clinically indicated RHC and IABP placement prior to LVAD surgery. Five control subjects undergoing left heart catheterization with an LV ejection fraction \> 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.

Participant milestones

Participant milestones
Measure	IABP Recipient Prospective, double-arm, pilot study. Conductance catheterization: CD Leycom Conductance Catheter	Control Group Control subjects undergoing left heart catheterization with an LV ejection fraction \> 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
Overall Study STARTED	10	5
Overall Study COMPLETED	10	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IABP Recipient n=10 Participants Conductance catheterization: CD Leycom Conductance Catheter	Control n=5 Participants Conductance catheterization: CD Leycom Conductance Catheter	Total n=15 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 14 • n=93 Participants	54 years STANDARD_DEVIATION 13 • n=4 Participants	56 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	3 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment United States	10 participants n=93 Participants	5 participants n=4 Participants	15 participants n=27 Participants
Body Surface Area (BSA)	2.07 m^2 STANDARD_DEVIATION 0.33 • n=93 Participants	2.22 m^2 STANDARD_DEVIATION 0.15 • n=4 Participants	2.12 m^2 STANDARD_DEVIATION 0.28 • n=27 Participants

PRIMARY outcome

Timeframe: 24 hours

We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.

Outcome measures

Outcome measures
Measure	IABP Recipient n=10 Participants Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery. Conductance catheterization: CD Leycom Conductance Catheter	Control n=5 Participants Control subjects undergoing left heart catheterization with an LV ejection fraction \> 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled. Conductance catheterization: CD Leycom Conductance Catheter
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. Stroke work without IABP	939 mmHg-mL Standard Deviation 302	5628 mmHg-mL Standard Deviation 2866
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. Stroke work with IABP	667 mmHg-mL Standard Deviation 210	NA mmHg-mL Standard Deviation NA Number value for control patients (who did not receive an IABP) should be 'not applicable'

Adverse Events

IABP Recipient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Navin Kapur

Tufts Medical Center

Phone: 617 636 0720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place