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The IMPULSE Study: Pilot

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02044471
Acronym
IMPULSE
Enrollment
20
Registered
2014-01-24
Start date
2014-08-31
Completion date
2016-12-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

left ventricular assist device, continuous flow, remote ischemic conditioning, hypertension, sympathetic tone, endothelial dysfunction

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.

Interventions

OTHERRemote Ischemic Conditioning (using Sphygmomanometer)

Patients in experimental arm will have validated protocol of Remote Ischemic Conditioning (using Sphygmomanometer): 5 minutes with blood pressure cuff inflated at 200 mmHg, then deflated for 5 minutes; repeated for 3 cycles. Patient in control group will not perform this.

Sponsors

Thoratec Corporation
CollaboratorINDUSTRY
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* \< 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
Change in mean doppler blood pressure6 weeksPatients 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

MeasureTime frameDescription
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 activity6 weeksmicroneurographic measures of sympathetic function via peroneal nerve

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026