Home-Based Fluid Status Monitoring in Heart Failure Patients

Stopped early

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT04013373

Run by

ImpediMed Limited

People needed

92

Starts

2018-10-09

Expected to finish

2021-07-30

Last updated by the study team

2021-08-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 years or older
• NYHA Class II or III at the time of study enrollment
• Undergoing discharge following hospitalization for acute heart failure
• Planned continued treatment for heart failure
• Patient is able to stand or sit upright for bioimpedance spectroscopy measurements
• Patient reports access to reliable Wi-Fi connection at home
• Patient reports adequate space for the SOZO device at home
• Patient provides written informed consent and authorization to use and disclose health information, including willingness to comply with study procedures

You may not qualify if…

• Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator)
• Patient has a confirmed diagnosis of acute coronary syndrome during current admission
• 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
• Patient has a clinical condition that would not allow them to complete the study
• Patient has had surgical revascularization using saphenous vein grafting that may affect venous return
• Patient is pregnant or lactating
• Patient has nephrotic syndrome or nephrosis
• Patient has end-stage renal disease requiring chronic dialysis
• Patient has been diagnosed with lymphedema
• Patient has chronic liver failure or cirrhosis
• Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days
• 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]
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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