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CTRI Number  CTRI/2026/03/105360 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 03/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Accuracy of congestion assessment in heart failure patients using a wearable device 
Scientific Title of Study   Assessing the accuracy of an investigative non-invasive chest worn wearable device in assessing congestion levels in heart failure patients - An observational pilot study 
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 Bhavesh Talaviya 
Designation  Consultant - Interventional Cardiology 
Affiliation  Surat Institute of Medical Science 
Address  Department of Cardiology, Surat Institute of Medical Science (SIMS Hospital), Lal Darwaja Station Road, Katargam RD, Near Modh Vanik Vadi, Lal Darwaja, Rughnathpura, Surat

Surat
GUJARAT
395003
India 
Phone  8000089007  
Fax    
Email  bvtalaviya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sriram Ganesan 
Designation  Vice President - Systems 
Affiliation  Anusar Medequips Pvt Ltd 
Address  Anusar Medequips Private Limited, Workhub by Novel Office, 37, Doddanekkundi Industrial Area, 2nd phase, Bangalore

Bangalore
KARNATAKA
560048
India 
Phone  9845396992  
Fax    
Email  sriram.ganesan@anusar.ai  
 
Details of Contact Person
Public Query  
Name  Sriram Ganesan 
Designation  Vice President - Systems 
Affiliation  Anusar Medequips Pvt Ltd 
Address  Anusar Medequips Private Limited, Workhub by Novel Office, 37, Doddanekkundi Industrial Area, 2nd phase, Bangalore


KARNATAKA
560048
India 
Phone  9845396992  
Fax    
Email  sriram.ganesan@anusar.ai  
 
Source of Monetary or Material Support  
Surat Institute of Medical Science (SIMS Hospital), Lal Darwaja Station Road, Katargam RD, Near Modh Vanik Vadi, Lal Darwaja, Rughnathpura, Surat 395003 
 
Primary Sponsor  
Name  Anusar Medequips Pvt Ltd  
Address  Anusar Medequips Private Limited, Workhub by Novel Office, 1st floor, 37, Doddanekkundi Industrial Area, 2nd phase, Bangalore 560 048, India  
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 Bhavesh Talaviya  Surat Institute of Medical Science  Cardiology OPD 7/596 597 Pooja Square Beside Modhvanik Ghanchi Lal Darwaja, Katargam Road, Surat 395003
Surat
GUJARAT 		 8000089007

bvtalaviya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIMS ETHICS COMMITTEE  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  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 first visit
4.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, 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 on IV ionotropic support
 
 
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 CT scan derived percentage lung fluid volume   Baseline - At first OPD visit
After 2 weeks after baseline - Second OPD visit 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation and statistical analysis of device reported fluid scores with NTproBNP value   At baseline (time of first visit), at the time of second visit(typically 7 to 14 days)  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   16/03/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 30 patients visiting OPD due to heart failure related issues, 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 (CT scan and NTproBNP) 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.

The primary endpoint of this study is to analyse the correlation of the device reported fluid score against percentagre lung fluid volume derived from CT thorax scan. The secondary endpoint of this study is to analyse the correlation between device reported fluid score and NTproBNP value.


 
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