Clinical Impact of Non-invasive Hemodynamic Monitoring

Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Preventative Care of Heart Failure Patients

Study Details

What is the study design? (eg, randomized, double-blind) Observational Prospective Study

What are the overall objectives of the study? This project is designed to assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure outpatient clinics. There will be no alteration to patient management for this study. Rather this study seeks to assess the utility of the device by evaluating for the parameters obtained from the device to hospital admission.

How your research will contribute to the advancement of scientific knowledge?

☒This study will confirm/strengthen existing knowledge. ☒This study will test a completely novel hypothesis. ☒This study will explore novel endpoints. ☐Other [please describe]:

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Observational Study to Evaluate Utility of Non-invasive Hemodynamic Monitoring

Detailed Description

B. BACKGROUND:

Nearly five million Americans experience heart failure (HF) and greater than 250,000 die annually. 1 The prevalence has continued to increase with the aging of the US population and HF is now the leading cause of hospitalization among adults >65 in the United states. Despite remarkable improvements in medical therapy, the prognosis of patients with myocardial failure remains poor, with almost 20% of patients dying within 1 year of initial diagnosis and > 80% 8-year mortality. 2 In addition patients who are admitted to the hospital for heart failure have over a 50% readmission rate within six months of discharge. 3,4 These patients require routine clinical care and often require diagnostic and therapeutic procedures. This project seeks to assess if the use of hemodynamic (HD) monitoring technologies (ClearSight/Nexfin) that are currently used in the intraoperative and critical care settings can provide utility by demonstrating associations between alterations in a patients HD values to the likelihood of hospital admission.

The non-invasive HD device utilized (Nexfin, Edwards Lifesciences, Irvine, CA) provided flow-guided cardiovascular parameters that were captured for each clinic visit for up to 24 months. Analysis was performed between the most recent prior clinic visits for patients who were hospitalized for HF exacerbation to those who were not hospitalized. HD data was not used to guide clinical care. A Cox hazard model using a log transformation of HD variables as the covariates, was applied to describe hospital admission.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Department of Anesthesiology
    • Loma Linda, California, United States, 92354
      • Pat Moore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients enrolled in the study will include those who are classified as New York Heart Association (NYHA) Functional Classification of three or greater

Description

Inclusion Criteria:

• Patients seen in Loma Linda heart failure clinics classified as New York Heart Association (NYHA) Functional Classification of 3 or greater.

Exclusion Criteria:

• Age < 18 years of age,
• pregnancy,
• known severe peripheral artery disease,
• poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
• history of Raynaud's,
• refusal to provide written consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
associations between alteration of HD values to hospital admission	24 months

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Davinder Ramsingh, MD, Loma Linda University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): November 19, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 5160245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes