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Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device

An Observational Study to Develop an Algorithm to Predict Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This is a prospective, observational pilot study designed to develop a mathematical algorithm capable of predicting decompensation of congestive heart failure (dCHF) using physiologic data collected from a non-invasive wearable device."
  • "Participants with a remote hemodynamic pulmonary artery pressure monitor will wear a wearable device continuously for up to 12 months."
  • "Wearable data will be analyzed in relation to the hemodynamic monitor defined sentinel events of heart failure decompensation to identify predictive signal patterns."
  • "Participants with chronic congestive heart failure and using a pulmonary artery pressure monitor will be enrolled and followed for a minimum of 6 months and up to 12 months."
  • "Physiologic data from the wearable-including heart rate, heart rate variability, sleep metrics, activity levels, oxygen saturation and temperature-will be collected continuously and analyzed in the 1-7 days preceding and following sentinel events."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is a prospective, observational pilot study designed to develop a mathematical algorithm capable of predicting decompensation of congestive heart failure (dCHF) using physiologic data collected from a non-invasive wearable device. Participants with a remote hemodynamic pulmonary artery pressure monitor will wear a wearable device continuously for up to 12 months. Wearable data will be analyzed in relation to the hemodynamic monitor defined sentinel events of heart failure decompensation to identify predictive signal patterns. Optional biospecimen (DNA, blood, urine) and voice sample collection will support future biomarker discovery.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * • Age ≥ 18 years * Current use of a hemodynamic sensoring device * At least 4 consecutive weeks of stabilized "goal" pulmonary artery pressures * Access to a personal smartphone with Wi-Fi or cellular connectivity Exclusion Criteria: * • Inability to provide informed consent * Inability to read or understand English * Likely non-adherence to wearable device use * Prisoners * Pregnant females

Study sites (2)

FL