Clinical trial NCT04013373: Home-Based Fluid Status Monitoring in Heart Failure Patients
Official title: Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Lead sponsor: ImpediMed Limited
Sponsor class: INDUSTRY
First posted: 2019-07-09
Enrollment: 92
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who are being discharged home from a hospitalization for heart failure

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Alliance Research Institute
state: California
city: Encinitas
country: United States
facility: Du Cardiology
state: California
city: Encinitas
country: United States
facility: San Diego Cardiovascular Associates
state: California
city: Garden Grove
country: United States
facility: SC Clinical Research
state: California
city: La Jolla
country: United States
facility: Scripps Clinic, John R. Anderson V Medical Pavilion
state: California
city: National City
country: United States
facility: MD Strategies Research Centers
state: California
city: Oceanside
country: United States
facility: Heart Care Associates
state: California
city: Vista
country: United States
facility: Blue Coast Cardiology
state: California
city: Clearwater
country: United States
facility: Research Alliance
state: Florida
city: Doral
country: United States
facility: Infinite Clinical Research
state: Florida
city: Miami
country: United States
facility: International Research Associates
state: Florida
city: North Miami Beach
country: United States
facility: Amavita Health
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Center
state: Florida
city: Flint
country: United States
facility: Flint Cardiovascular
state: Michigan
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
Study officials:
affiliation: Scripps Clinic
name: James T Heywood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Accardi AJ, Matsubara BS, Gaw RL, Daleiden-Burns A, Heywood JT. Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy. Front Cardiovasc Med. 2021 Apr 7;8:636718. doi: 10.3389/fcvm.2021.636718. eCollection 2021.