Relation of Non-invasively Measured Parameters to Clinical Outcomes in CHF Patients

NCT04548024 | Completed FDA Device

• 1 other identifier: PPGCHF001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to assess whether changes in CO, CI and SVR as measured using the Biobeat wearable, wireless, non-invasive device during IV diuretic administration in an outpatient setting among CHF patients correlate with short-term clinical change measured using symptoms questionnaires, change in weight and urine output. We will also assess the correlation between baseline values of those parameters and long-term clinical outcomes, measured by HF hospitalizations and the change in disease perception and quality of life reported in questionnaires.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Non-invasive monitoring; Remote Patient Monitoring

Outcome Measures

Primary Outcomes (1)

• To assess whether the changes in vital signs during IV diuretic administration correlate with short-term clinical change.

  To assess whether the changes in CO, CI and SVR measured by a wearable wireless non-invasive device during IV diuretic administration correlate with short-term clinical change measured using symptoms questionnaires, change in weight and urine output.

  4-10 hours per patient

Secondary Outcomes (1)

• To assess the correlation between baseline values and long-term clinical outcomes.

  2 years

Interventions

Short term monitoring DEVICE

By using the Biobeat monitoring device, we will monitor CHF patients during an outpatient visit and during treatment with diuretics.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 patients \>18 years of age, diagnosed with heart failure, arriving to Hadassah Ein Kerem outpatient clinic to receive IV diuresis, will be enrolled in the study

You may qualify if:

• Diagnosis of heart failure
• A Recent echocardiography report (from the last 2 year)
• Treatment with IV diuresis at Hadassah Ein Kerem outpatient clinic

You may not qualify if:

• Patient does not give consent to participate in the study, or is unable to give consent due to cognitive or mental impairment
• Patient is under 18 years old
• Patient is unable to answer questions regarding his condition
• Pregnant women
• Worker from Hadassah Medical Center

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead

Study Sites (1)

The Hadassah Ein Kerem Medical Center

Jerusalem, POB 12000, Israel

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dean Nachman, MD

  The Hadassah Ein Kerem Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: September 10, 2020
• Primary Completion: November 10, 2021
• Study Completion: December 10, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

IL (1)