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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343523
• Other study ID #: 14-6510
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: May 4, 2016
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that simultaneously tracks and records a number of physiological health related parameters such as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One advantage of this device over current home diagnostic systems is the capability for longitudinal monitoring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Symptoms:

• Onset or worsening of dyspnea within the past 2 weeks

2. Physical exam (at least 1 present):

• Rales/ Crackles on auscultation

• Elevated JVP > 10 cmH2O

• Weight gain

• LE edema

3. 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)

Exclusion Criteria:

• 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

Study Design

N/A

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Scripps Health	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No