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

NCT07350759 | Recruiting DMC

• 1 other identifier: STUDY 008961
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Decompensated Chronic Heart Failure

Keywords

congestive heart failure; wearable monitor; predictive algrothim

Outcome Measures

Primary Outcomes (1)

• Changes in multiple physiologic parameters from baseline that correlate with onset of dCHF

  Identification of reproducible changes in wearable physiologic data that occur in the 1-7 days preceding a hemodynamic monitoring device detection of elevated pulmonary artery pressure sustained over 2 days defined as a sentinel event of decompensated CHF.

  Up to 12 Months

Study Arms (1)

Patients with congestive heart failure

Patients will be monitored by a a tiny, battery-free pressure sensor implanted in a branch of the pulmonary artery via a right-heart catheterization, previously placed for a history of decompensating heart failure.

Device: wearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters

Interventions

wearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters DEVICE

In this observational study, a non-invasive, wearable ring used for continuous passive collection of physiologic data (sleep, activity, heart rate, HRV, temperature) will be used to collect data from all patients in the study. Data are used solely for research and algorithm development and are not used for diagnosis or treatment.

Patients with congestive heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of South Florida Tampa General Hospital

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent
• Inability to read or understand English
• Likely non-adherence to wearable device use
• Prisoners
• Pregnant females

Sponsors & Collaborators

• CHFDX,Inc.: lead
• Tampa General Hospital: collaborator
• University of South Florida: collaborator

Study Sites (2)

USF Office of Clinical Research

Tampa, Florida, 33612, United States

NOT YET RECRUITING

USF

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (11)

• Shavelle DM, Desai AS, Abraham WT, Bourge RC, Raval N, Rathman LD, Heywood JT, Jermyn RA, Pelzel J, Jonsson OT, Costanzo MR, Henderson JD, Brett ME, Adamson PB, Stevenson LW; CardioMEMS Post-Approval Study Investigators. Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study. Circ Heart Fail. 2020 Aug;13(8):e006863. doi: 10.1161/CIRCHEARTFAILURE.119.006863. Epub 2020 Aug 6.

  PMID: 32757642 BACKGROUND

• Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.

  PMID: 21315441 BACKGROUND

• Desai AS, Bhimaraj A, Bharmi R, Jermyn R, Bhatt K, Shavelle D, Redfield MM, Hull R, Pelzel J, Davis K, Dalal N, Adamson PB, Heywood JT. Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in "Real-World" Clinical Practice. J Am Coll Cardiol. 2017 May 16;69(19):2357-2365. doi: 10.1016/j.jacc.2017.03.009. Epub 2017 Mar 19.

  PMID: 28330751 BACKGROUND

• 8. JoAnn Lindenfeld, on behalf of the GUIDE-HF, CHAMPION, and LAPTOPHF investigators. Longer Term Effects of Hemodynamic Monitoring on Outcomes: A Combined Data Analysis of patients with HFrEF in CHAMPION, GUIDE-HF, and LAPTOP-HF. Presented at THT Conference, Boston, MA, March 2023.

  BACKGROUND

• Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.

  PMID: 26560249 BACKGROUND

• Givertz MM, Stevenson LW, Costanzo MR, Bourge RC, Bauman JG, Ginn G, Abraham WT; CHAMPION Trial Investigators. Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2017 Oct 10;70(15):1875-1886. doi: 10.1016/j.jacc.2017.08.010.

  PMID: 28982501 BACKGROUND

• Adamson PB. Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: new insights from continuous monitoring devices. Curr Heart Fail Rep. 2009 Dec;6(4):287-92. doi: 10.1007/s11897-009-0039-z.

  PMID: 19948098 BACKGROUND

• Redfield MM. Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2016 Nov 10;375(19):1868-1877. doi: 10.1056/NEJMcp1511175. No abstract available.

  PMID: 27959663 BACKGROUND

• Ellison DH, Felker GM. Diuretic Treatment in Heart Failure. N Engl J Med. 2017 Nov 16;377(20):1964-1975. doi: 10.1056/NEJMra1703100. No abstract available.

  PMID: 29141174 BACKGROUND

• Scott MC, Winters ME. Congestive Heart Failure. Emerg Med Clin North Am. 2015 Aug;33(3):553-62. doi: 10.1016/j.emc.2015.04.006. Epub 2015 Jun 10.

  PMID: 26226866 BACKGROUND

• Chen J, Aronowitz P. Congestive Heart Failure. Med Clin North Am. 2022 May;106(3):447-458. doi: 10.1016/j.mcna.2021.12.002. Epub 2022 Apr 4.

  PMID: 35491065 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

saliva, plasma, urine

MeSH Terms

Conditions

Heart Failure

Interventions

Respiratory Rate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Wu, DO

  Tampa General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robby Wu, DO

CONTACT

813-844-7000; Robbywu@usf.edu

Rohitha Moudgal, MD

CONTACT

813-844-7000; rohitamoudgal@usf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 20, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)