The IMPULSE Study: Pilot
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/29/2017 |
| Start Date: | August 2014 |
| End Date: | December 2016 |
The IMPULSE Pilot Study-- Investigating a Novel Synergy: Applying Ischemic Conditioning to Modulate the Altered Physiology From Contemporary continUous Flow Left Ventricular Assist Devices, to Reduce Stroke and Other Adverse Effects
Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the
treatment of end-stage heart failure, affording patients significantly improved quantity and
quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide,
with nearly 1,000 at the Texas Heart Institute (THI). Despite the benefits from LVAD
therapy, one major weakness is the high frequency of late strokes, reported up to 19%. CF
LVADs minimize or remove the pulsatility within the blood system, introducing a new and
incompletely understood physiology.
Increased sympathetic ("fight or flight" nervous system) tone secondary to lack of pulse in
the blood system can cause high blood pressure, with subsequent hemorrhaging strokes
(bleeding into the brain) are one possible explanation for this high adverse event rate in
CF LVAD patients. A simple intervention to decrease the increased sympathetic tone is called
"ischemic conditioning"; a sphygmomanometer (blood pressure cuff) is placed on the patient's
arm to compress a major artery (ischemia) with subsequent release of the cuff (reperfusion)
for set periods of time. This has been shown to reduce blood pressure and major adverse
cardiovascular events in other patient populations.
We plan to conduct a trial to evaluate this intervention, ischemic conditioning, in patients
with CF LVADs. We hypothesize that IC will cause a reduction in blood pressure and strokes
in this patient population.
treatment of end-stage heart failure, affording patients significantly improved quantity and
quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide,
with nearly 1,000 at the Texas Heart Institute (THI). Despite the benefits from LVAD
therapy, one major weakness is the high frequency of late strokes, reported up to 19%. CF
LVADs minimize or remove the pulsatility within the blood system, introducing a new and
incompletely understood physiology.
Increased sympathetic ("fight or flight" nervous system) tone secondary to lack of pulse in
the blood system can cause high blood pressure, with subsequent hemorrhaging strokes
(bleeding into the brain) are one possible explanation for this high adverse event rate in
CF LVAD patients. A simple intervention to decrease the increased sympathetic tone is called
"ischemic conditioning"; a sphygmomanometer (blood pressure cuff) is placed on the patient's
arm to compress a major artery (ischemia) with subsequent release of the cuff (reperfusion)
for set periods of time. This has been shown to reduce blood pressure and major adverse
cardiovascular events in other patient populations.
We plan to conduct a trial to evaluate this intervention, ischemic conditioning, in patients
with CF LVADs. We hypothesize that IC will cause a reduction in blood pressure and strokes
in this patient population.
Inclusion Criteria:
- continuous flow LVAD and able to provide informed consent and comply with follow-up
Exclusion Criteria:
- < 18 years of age
We found this trial at
1
site
1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Phone: 832-355-3000
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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