Home-Based Fluid Status Monitoring in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04013373
• Other study ID #: IPD-HBHF-001
• Status: Terminated
• Start date: October 9, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: ImpediMed Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-center, single-arm study enrolling adult patients who have been hospitalized for heart failure and subsequently discharged. For the duration of study participation, patients will obtain daily at-home bioimpedance measurements. Heart failure symptoms, medications, and re-hospitalizations will be tracked. Additionally, quality of life questionnaires will be administered at the beginning and end of study participation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Age 21 years or older

2. NYHA Class II or III at the time of study enrollment

3. Undergoing discharge following hospitalization for acute heart failure

4. Planned continued treatment for heart failure

5. Patient is able to stand or sit upright for bioimpedance spectroscopy measurements

6. Patient reports access to reliable Wi-Fi connection at home

7. Patient reports adequate space for the SOZO device at home

8. Patient provides written informed consent and authorization to use and disclose health information, including willingness to comply with study procedures

Exclusion Criteria:

1. Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator)

2. Patient has a confirmed diagnosis of acute coronary syndrome during current admission

3. Patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion

4. Patient has a clinical condition that would not allow them to complete the study

5. Patient has had surgical revascularization using saphenous vein grafting that may affect venous return

6. Patient is pregnant or lactating

7. Patient has nephrotic syndrome or nephrosis

8. Patient has end-stage renal disease requiring chronic dialysis

9. Patient has been diagnosed with lymphedema

10. Patient has chronic liver failure or cirrhosis

11. Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days

12. Patient has an amputation of a limb [Exception: amputation of digits may not affect bioimpedance spectroscopy measurements and will be permitted at the discretion of the study sponsor]

13. Patient has any other medical condition that, in the opinion of the investigator, will impair the subject's ability to complete study procedures or participate in the protocol

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• SOZO Bioimpedance Spectroscopy Device
Bioimpedance spectroscopy measurements for assessment of fluid status

Locations

Country	Name	City	State
United States	Alliance Research Institute	Canoga Park	California
United States	Research Alliance	Clearwater	Florida
United States	Infinite Clinical Research	Doral	Florida
United States	Du Cardiology	Encinitas	California
United States	San Diego Cardiovascular Associates	Encinitas	California
United States	Flint Cardiovascular	Flint	Michigan
United States	SC Clinical Research	Garden Grove	California
United States	Scripps Clinic, John R. Anderson V Medical Pavilion	La Jolla	California
United States	Sierra Clinical Research	Las Vegas	Nevada
United States	International Research Associates	Miami	Florida
United States	MD Strategies Research Centers	National City	California
United States	Amavita Health	North Miami Beach	Florida
United States	Heart Care Associates	Oceanside	California
United States	Broward Research Center	Pembroke Pines	Florida
United States	Blue Coast Cardiology	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
ImpediMed Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water	Characterize BIS trends that precede hospital readmissions for heart failure	45 days