CTRI

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CTRI Number

CTRI/2025/08/092786 [Registered on: 11/08/2025] Trial Registered Prospectively

Last Modified On:

11/08/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Single Arm Study

Public Title of Study

Observational study on 50 admitted heart failure patients for congestion level assessment using an investigative chest-worn wearable device

Scientific Title of Study

A non invasive chest worn wearable device in assessing congestion levels in acutely decompensated heart failure patients An Observational Pilot

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Mohit Bhagwati
Designation	Consultant - Department of Cardiology
Affiliation	Holy Family Hospital
Address	Dr Mohit Bhagwati Department of Cardiology, Holy Family Hospital, Okhla Road, New Delhi New Delhi DELHI 110025 India
Phone	9650116400
Fax
Email	mohitbhagwati@gmail.com

Details of Contact Person
Scientific Query

Name	Sriram Ganesan
Designation	Vice President
Affiliation	Anusar Medequips Pvt Ltd
Address	Anusar Medequips Pvt. Ltd., Workhub by Novel Office, 1st floor, 37, Doddanekkundi Industrial Area, Phase 2 Bangalore KARNATAKA 560048 India
Phone	9845396992
Fax
Email	sriram.ganesan@anusar.ai

Details of Contact Person
Public Query

Name	Sriram Ganesan
Designation	Vice President
Affiliation	Anusar Medequips Pvt Ltd
Address	Anusar Medequips Pvt. Ltd., Workhub by Novel Office, 1st floor, 37, Doddanekkundi Industrial Area, Phase 2 KARNATAKA 560048 India
Phone	9845396992
Fax
Email	sriram.ganesan@anusar.ai

Source of Monetary or Material Support

Anusar Medequips Pvt Ltd, Workhub by Novel Office, 37, Doddanekkundi Industrial Area, Phase 2, Whitefield Road, Bangalore 560048

Primary Sponsor

Name	Anusar Medequips Pvt Ltd
Address	37, Workhub by Novel Office, 1st floor, Doddanekkundi Industrial Area Phase 2, Bangalore 560048
Type of Sponsor	Other [Medical device manufacturer]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Mohit Bhagwati	Holy Family Hospital	Department of Cardiology, Cardiac Interventional Management division, Holy Family Hospital, Okhla Road, New Delhi New Delhi DELHI	9650116400 mohitbhagwati@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee Holy Family Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I504\|\|Combined systolic (congestive) anddiastolic (congestive) heart failure,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1.Age above 18 years 2.Patients under diuretic treatment for heart failure 3.Patients having enough cognitive ability to give informed consent

ExclusionCriteria

Details

1.Pregnant women or women planning for pregnancy
2.Having any implanted devices such as pacemakers, ICDs etc.
3.Suffering from cancer
4.Suffering from severe liver disease or in septic shock

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Correlation and statistical analysis of device reported fluid scores with current state of the art clinical methods (NTproBNP, fluid balance and Echocardiogram reported RVSP)	At baseline (time of admission), at the time of discharge (typically 2 to 7 days), at the time of OPD visit (typically 7 days after discharge

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

25/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Heart failure is a major problem that drains the healthcare expenditure across the world and in India as well. The largest chunk of heart failure expense is due to repeated hospital admissions that becomes necessary in these patients. Most heart failure decompensation events that lead to hospital admissions are due to severe lung congestion and diuretics are the most commonly used therapy to manage congestion. Optimally titrating the diuretic dosage however, has been a major challenge due to the lack of reliable and simple tools to quantify the extent of congestion. This leads to either inadequate diuresis or excessive diuresis both of which result in poor prognosis, re-hospitalizations and increased mortality.

AnuSar Medequips private limited, a medical device startup company has developed a fully non-invasive, chest worn wearable patch device, which can provide the patient’s thoracic fluid status level continuously in real time. This observational study is intended to assess the possibility of using this device as a future tool to assess the congestion levels in heart failure patients while they are admitted in the hospital. Such an objective tool (instead of being subjective to the clinical judgement) can enable optimally titrating the diuretics and other medications to relieve congestion, which can lead to better clinical outcomes.

The intent of this clinical study on 50 patients admitted due to acute decompensation of heart failure, is to assess the feasibility of using a chest worn, battery powered, non-invasive wearable investigative device as a tool to assess the congestion status in heart failure patients. This would be a purely observational data collection study where data would be collected from the wearable device alongside other standard clinical parameters (NTproBNP and Echocardiogram) used in clinical practice. No clinical decision would be made based on the device reported findings. No patient identifiable information would be entered or stored in the device application.