Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

NCT02343523 | Completed

• 1 other identifier: 14-6510
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.

Conditions

Heart Failure

Keywords

Wearable device; Wrist-watch; Longitudinal monitoring; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• To capture continuous vital signs via a wrist-based wearable physiologic monitor among patients with acute decompensated heart failure (ADHF) in 2 phases

  Phase 1: Will include hospitalized patients admitted to the hospital with a clinical diagnosis of ADHF. Phase 2: Will include patients being discharged from the hospital with a primary clinical diagnosis of ADHF and will be monitored for up to 30 days following hospitalization.

  ~7to 30 days

Secondary Outcomes (1)

• To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.

  ~40 days

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population in both phases of the study will be made up of adult men and women admitted to the hospital with a clinical diagnosis of acute decompensated heart failure. Phase 1 and Phase 2 will include up to 10 individuals each that meet the following Inclusion criteria and have no Exclusion criteria.

You may qualify if:

• Adults over age 18
• Own, and comfortable using, a home computer with internet access (Phase 2 only)
• Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:
• Symptoms:
• Onset or worsening of dyspnea within the past 2 weeks
• Physical exam (at least 1 present):
• Rales/ Crackles on auscultation
• Elevated JVP \> 10 cmH2O
• Weight gain
• LE edema
• Diagnostic imaging/ labs (at least 1 present):
• Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
• Elevated BNP or NT-pro-BNP (age-adjusted)

You may not qualify if:

• Psychological or social situation that would make the study difficult for the patient
• Inability to consent
• Chronic atrial fibrillation or other dysrhythmia with a high (\>10%) burden of ectopic beats.
• Pregnant women
• Pneumonia - currently, or within the past 30 days
• Non-cardiogenic pulmonary edema (e.g. ARDS)
• Interstitial lung disease
• End-stage renal disease and on Hemodialysis

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Health

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Steven Steinhuble, MD

  STSI

  PRINCIPAL INVESTIGATOR

• Ajay Srivastava, MD

  STSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)