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Evaluating the accuracy of a non-invasive chest worn wearable device in assessing congestion levels in heart failure patients An observational pilot study

A single centre, open, non-controlled, observational, investigator initiated, data collection study to assess the feasibility of using an investigative non-invasive chest worn wearable device to assess congestion levels in heart failure patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/101227
Enrollment
30
Registered
2026-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure

Interventions

Intervention1: Nil: Nil

Sponsors

Anusar Medequips Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 40 years or more 2.Patients admitted for acutely decompensated heart failure with symptom class II, III or IV 3.Patients with confirmed LV dysfunction with LVEF less than 40 percent and NTproBNP more than 1000 pg per mL, measured at the time of admission 4.Patients having enough cognitive ability to give informed consent

Exclusion criteria

Exclusion criteria: 1.Pregnant women or women planning for pregnancy 2.Having any implanted devices such as pacemakers, ICDs etc. 3.Suffering from cancer, liver disease or in septic shock 4.Patients on mechanical ventilator support or NIV support 5.Patients with infected lung pathologies, suspected or established pneumonia 6.Patients needing IV ionotropic support at the time of admission

Design outcomes

Primary

MeasureTime frame
Correlation and statistical analysis of device reported fluid scores with CT scan derived lung fluid scoreTimepoint: At baseline (time of admission), at the time of discharge (typically 2 to 7 days)

Secondary

MeasureTime frame
Correlation and statistical analysis of device reported fluid scores with NTproBNP valueTimepoint: At baseline (time of admission), at the time of discharge (typically 2 to 7 days)

Countries

India

Contacts

Public ContactSriram Ganesan

Anusar Medequips Pvt. Ltd.

sganesan@anusar.com9845396992

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026