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CTRI Number  CTRI/2023/10/058186 [Registered on: 03/10/2023] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   To evaluate the relation between two assessment procedures (FVD & VExUS) for predicting organ dysfunction in heart failure patients. 
Scientific Title of Study   Correlation of serial femoral venous Doppler versus VExUS score to predict organ dysfunction and outcomes in patients with cardiac failure. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Version Number 1.0 Dated 10/05/2023  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vimal Bhardwaj  
Designation  Consultant Intensivist 
Affiliation  Narayana Health 
Address  Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd, Bengaluru

Bangalore
KARNATAKA
560099
India 
Phone  9686124830  
Fax    
Email  vmlbhardwaj@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vimal Bhardwaj  
Designation  Consultant Intensivist 
Affiliation  Narayana Health 
Address  Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd, Bengaluru

Bangalore
KARNATAKA
560099
India 
Phone  9686124830  
Fax    
Email  vmlbhardwaj@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vimal Bhardwaj  
Designation  Consultant Intensivist 
Affiliation  Narayana Health 
Address  Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd, Bengaluru

Bangalore
KARNATAKA
560099
India 
Phone  9686124830  
Fax    
Email  vmlbhardwaj@yahoo.co.in  
 
Source of Monetary or Material Support  
Narayana Hrudayalaya, 258/A Bommasandra Industrial area, Hosur Road, Bengaluru, 560099 
 
Primary Sponsor  
Name  Dr Vimal Bhardwaj  
Address  Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd, Bangalore 
Type of Sponsor  Other [Self] 
 
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 Vimal Bharadwaj  Narayana Hrudayalaya   #258/A, 6th floor, Cardiac ICU, Department of critical care services, Narayana Health cardiac building, Bommasandra Industrial Area, Hosur Road, Bengaluru, 560099
Bangalore
KARNATAKA 		 9686124830

vmlbhardwaj@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Getting admited with a diagnosis of acute heart failure [defined as recent worsening of shortness of breath or oxygen saturation (SpO2) < 90% on room air or orthopnea/paroxysmal nocturnal dypnea (PND) along with an increase in NT proBNP] 
 
ExclusionCriteria 
Details  1.Need for intubation (or already intubated).
2.Signs or symptoms or markers of hypoperfusion: cold extremities, altered mentation, confusion, oliguria, Lactate > 2 mmol/L.
3.Persistent hypotension (SBP < 90 mmHg).
4.Requirement of two or more vasoactive agents to maintain blood pressure.
5.Requirement for invasive cardiac output monitoring.
6.Requirement for Mechanical Circulatory Support.
7.Heart rate < 40 b.pm or persistent life-threatening arrhythmia.
8.Any associated non-cardiac condition requiring critical care admission.
9.Pulmonary arterial systolic pressure > 55mm/hg by bedside 2d-echocardiography
10.Patients with comfort care directives.
11.Suspected sepsis
12.Pregnancy
13.Liver cirrhosis
14.Severe ascites (Grade 3 Ascites defined as Large or gross ascites with marked abdominal distension) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare serial FVD and serial VExUS scoring as a predictor of organ dysfunction in acute heart failure patients.   Until admitted in ICU 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the degree of venous congestion assessed by serial femoral venous Doppler in acute heart failure patients with organ dysfunction.  Until admitted in ICU 
To determine the utility of femoral venous Doppler as a prognostic marker in acute heart failure patients.  Until admitted in ICU 
To determine the correlation between femoral venous Doppler and right ventricular function.  Until admitted in ICU  
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
Final Enrollment numbers achieved (Total)= "111"
Final Enrollment numbers achieved (India)="111" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/10/2023 
Date of Study Completion (India) 12/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 https://doi.org/10.1186/s44158-025-00283-6 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Femoral venous Doppler (FVD) assessment for venous congestion (VC) is a newer tool and it is technically easier to acquire images of the vein compared to venous excess ultrasound grading (VExUS). Also, since the common femoral vein is directly connected to the inferior vena cava (IVC), facilitating the transmission of pressure waves as the VC increases due to heart failure (HF). Patterns in FVD describing the degree of congestion have been studied and documented. Also, few studies have used FVD to develop diagnostic algorithms. Recently, FVD has also been proposed as a tool to diagnose right ventricular dysfunction in patients undergoing cardiac surgery.

FVD has an advantage that it is simpler to measure than the VExUS and also quantify the degree of VC. With this background, FVD appears to be having a potential in predicting the degree of organ dysfunction due to VC. This could in turn lead to HF regimens being optimized to normalization of FVD patterns for better outcome in patients. Till date, there have been no prospective studies evaluating the utility of FVD to assess VC in patients with acute heart failure.

The aim of this study is to see whether serial FVD scans to assess the degree of VC have a correlation with organ dysfunction in patients admitted to intensive care unit with acute heart failure.

 We propose to conduct a prospective observational study to assess the utility of serial FVD and VEXuS score in predicting the morbidity of patients with acute heart failure admitted to intensive care unit.

 
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