The IMPULSE Study: Pilot

Chronic Heart Failure Clinical Trial

— IMPULSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044471
• Other study ID #: H-35006
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: April 27, 2017
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 years of age

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• Remote 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Thoratec Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean doppler blood pressure	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.	6 weeks
Secondary	change in mean levels of inflammatory markers (TNFa, IL6, IL8, IL10) and endothelial function (adenosine, acetylcholine, bradykinin, nitric oxide, angiotensin, aldosternone)		6 weeks
Secondary	change in sympathetic neuronal activity	microneurographic measures of sympathetic function via peroneal nerve	6 weeks