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Home-Based Fluid Status Monitoring in Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT04013373
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
ImpediMed Limited

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.

Condition or disease Intervention/treatment
Heart Failure Device: SOZO Bioimpedance Spectroscopy Device

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
BIS home-based monitoring Device: SOZO Bioimpedance Spectroscopy Device
Bioimpedance spectroscopy measurements for assessment of fluid status




Primary Outcome Measures :
  1. Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water [ Time Frame: 45 days ]
    Characterize BIS trends that precede hospital readmissions for heart failure



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who are being discharged home from a hospitalization for heart failure
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013373


Contacts
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Contact: Catherine Kingsford (877) 247-0111 ckingsford@impedimed.com

Locations
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United States, California
Alliance Research Institute Recruiting
Canoga Park, California, United States, 91304
Contact: Arash Vahdat, MD         
Du Cardiology Recruiting
Encinitas, California, United States, 92024
Contact: Pingfeng Du, MD, PhD         
San Diego Cardiovascular Associates Recruiting
Encinitas, California, United States, 92024
Contact: Patrick McGinty, MD         
SC Clinical Research Recruiting
Garden Grove, California, United States, 92844
Contact: Michael Dao, MD         
Scripps Clinic, John R. Anderson V Medical Pavilion Recruiting
La Jolla, California, United States, 92037
Contact: James T Heywood, MD         
Contact: Andrew J Accardi, MD         
MD Strategies Research Centers Recruiting
National City, California, United States, 91950
Contact: Albert Sharf, MD         
Heart Care Associates Recruiting
Oceanside, California, United States, 92056
Contact: Karim El-Shereif, MD         
Contact: Anitha Rajamanickam, MD         
Blue Coast Cardiology Recruiting
Vista, California, United States, 92083
Contact: Hanh Bui, MD         
United States, Florida
Research Alliance Recruiting
Clearwater, Florida, United States, 33756
Contact: Salah Amer, MD         
Infinite Clinical Research Recruiting
Doral, Florida, United States, 33126
Contact: Melvin Martinez, MD         
International Research Associates Recruiting
Miami, Florida, United States, 33183
Contact: Cristian Breton, MD         
Amavita Health Recruiting
North Miami Beach, Florida, United States, 33169
Contact: Pedro Clark, MD         
Broward Research Center Recruiting
Pembroke Pines, Florida, United States, 33024
Contact: Juan Londono, MD         
United States, Michigan
Flint Cardiovascular Recruiting
Flint, Michigan, United States, 48532
Contact: Samir Elian, MD         
United States, Nevada
Sierra Clinical Research Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Vishweshwar Ranga, MD         
Sponsors and Collaborators
ImpediMed Limited
Investigators
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Principal Investigator: James T Heywood, MD Scripps Clinic

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Responsible Party: ImpediMed Limited
ClinicalTrials.gov Identifier: NCT04013373     History of Changes
Other Study ID Numbers: IPD-HBHF-001
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases