The IMPULSE Study: Pilot

NCT ID: NCT02044471

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-12-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Our intervention will be ischemic conditioning (IC) remotely applied using a sphygmomanometer. We will use the standard, validated protocol, which is inflation of the sphygmomanometer to 200 mmHg for 5 minutes, then deflation with 5 minutes of reperfusion, repeated for 3 cycles (total 30 minutes). This will be done in the dominant arm, twice daily.

Once patients are discharged home on a stable pharmacotherapy regimen, they will be expected to follow the above intervention for 6 weeks, followed by another 6 weeks in the control (no intervention) phase. Patients will be randomized as to which phase they begin the study.

Group Type: EXPERIMENTAL

Remote Ischemic Conditioning (using Sphygmomanometer)

Intervention Type: OTHER

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.

Control

standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• < 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thoratec Corporation

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Gilberto Defreitas

RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilberto Defreitas, RN

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-35006

Identifier Type: -

Identifier Source: org_study_id