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Clinical Trials/NCT02044471
NCT02044471
Completed
N/A

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

Baylor College of Medicine1 site in 1 country20 target enrollmentAugust 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Baylor College of Medicine
Enrollment
20
Locations
1
Primary Endpoint
Change in mean doppler blood pressure
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gilberto Defreitas

RN

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • continuous flow LVAD and able to provide informed consent and comply with follow-up

Exclusion Criteria

  • \< 18 years of age

Outcomes

Primary Outcomes

Change in mean doppler blood pressure

Time Frame: 6 weeks

Patients will follow a standard, validated protocol for this non-invasive technique for 6 weeks, followed by 6 weeks in the control phase (or vice versa based on randomization of order). Each week, they will have Doppler blood pressure measurements and blood samples drawn for analysis.

Secondary Outcomes

  • change in mean levels of inflammatory markers (TNFa, IL6, IL8, IL10) and endothelial function (adenosine, acetylcholine, bradykinin, nitric oxide, angiotensin, aldosternone)(6 weeks)
  • change in sympathetic neuronal activity(6 weeks)

Study Sites (1)

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