Heart failure and acute renal dysfunction in the cardiorenal syndrome.
Rajinder S Chahal, Chukwuma A Chukwu, Paul R Kalra...
https://pubmed.ncbi.nlm.nih.gov/32188648Actively Recruiting
Age: 18Years +
All Genders
ID06397833
A Prospective Observational Study to Assess the Acorai Intracardiac Pressure Monitoring System in Predicting Outcomes in Patients Discharged After Acute Decompensated Heart Failure
Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2025-04-08
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Acorai Heart Monitor, a handheld device designed to non-invasively measure pressures inside the heart in patients with heart failure. This observational study aims to assess the feasibility of using the Acorai device to predict survival, death, or major adverse cardiac events in patients who have been hospitalized with acute decompensated heart failure and are awaiting discharge home. The need for such a tool arises because current intracardiac pressure measurements require invasive right heart catheterization, which carries risks to patients. The Acorai Heart Monitor is an extended smartphone case equipped with various sensors that detect low-frequency sound and seismic signals related to intracardiac pressure. During the study, patients will have the device placed on their chest for five minutes while lying down, along with a small smart wristwatch to collect data. The study is single-arm, non-randomized, and non-significant risk, focusing on collecting non-invasive cardiac output measurements to evaluate the Acorai systems ability to predict outcomes. Participants will be patients recently hospitalized for decompensated heart failure who have received intravenous diuretic therapy and are medically fit for discharge. Researchers will monitor and assess intracardiac pressure data collected by the Acorai device and compare it with clinical outcomes over one year, including survival and hospital readmission. The primary outcome is the feasibility of predicting survival and hospitalization at one year. Secondary outcomes include predicting major adverse cardiac events and identifying which measurements best predict prognosis. The study is expected to last at least one year for each participant.
CONDITIONS
Brief Title
A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Medically fit for discharge following hospital admission with decompensated heart failure requiring intravenous diuretic therapy
- Willing and physically able to comply with the study evaluations
- Able to provide written consent to participate in the study
You will not qualify if you...
- Pregnancy
- Investigator discretion if participation is not in the best interest of the subject or the study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single session at discharge
Participants will have the handheld Acorai ICPM system placed on their chest for 5 minutes to record sensor data non-invasively.
1 visit (in-person)
Long-term Monitoring
Duration - 1 year
Participants are observed for up to 1 year after discharge to assess survival and hospitalisation outcomes.
Follow-up assessments as per routine care
Trial Site Locations
Total: 1 location
1
Harefield Hospital
Uxbridge, Middlesex, United Kingdom, UB9 6JH
Actively Recruiting
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Research Team
O
Owais Dar, MB ChB MD Res
R
Ramey Assaf, MBBS BMedSci
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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R S Gardner, G Henderson, T A McDonagh
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