| CTRI Number |
CTRI/2024/10/075219 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
To assess the relationship between two different heart ultrasound techniques and its importance for evaluating right ventricular heart function in a population of heart failure patients. |
|
Scientific Title of Study
|
Correlation of Venous Congestion and S Prime (S) in Echocardiography. Implications for Right Ventricular Function Assessment in Heart Failure Patients |
| 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 Pramukh Hegde |
| Designation |
Resident Doctor, Dept of Critical Care Medicine |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9113879418 |
| Fax |
|
| Email |
pramukh.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramukh Hegde |
| Designation |
Resident Doctor, Dept of Critical Care Medicine |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9113879418 |
| Fax |
|
| Email |
pramukh.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramukh Hegde |
| Designation |
Resident Doctor, Dept of Critical Care Medicine |
| Affiliation |
Narayana Institute of Cardiac Sciences |
| Address |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9113879418 |
| Fax |
|
| Email |
pramukh.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Institute Of Cardiac Sciences, 258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Bengaluru, India, 560099 |
|
|
Primary Sponsor
|
| Name |
Dr. Pramukh Hegde |
| Address |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Bengaluru, Karnataka 560099 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramukh Hegde |
Narayana Institute of Cardiac Sciences |
Dept of Critical Care Unit, 6th Floor, Narayana Institute Of Cardiac Sciences, 258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area
Bangalore Rural
KARNATAKA |
9113879418
pramukh.hegde@gmail.com |
|
|
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
|
|
|
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 |
1.Adult patients (aged above 18 years) diagnosed with heart failure according to established guidelines (AHA guidelines).
2.Patients undergoing echocardiography for clinical indications.
3. Ability to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications to echocardiography.
2.Patient is on mechanical ventilator support with peep more than 5 and NIV of EPAP of more than 10
3.Patients with severe comorbidities including, but not limited to-
a) End-stage renal disease requiring dialysis
b) Advanced liver disease (examples – cirrhosis with significant portal hypertension and massive ascites)
c) Advanced malignancy with limited life expectancy (less than 6 months)
d) Decompensated severe chronic obstructive pulmonary disease (COPD)
e) Pregnancy
f) Active systemic infections requiring hospitalization or intravenous antibiotics
g) Severe non-cardiac medical conditions requiring intensive medical management or surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the correlation between venous congestion and S prime in Heart Failure patients. |
Baseline assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of venous congestion on RV systolic function and to evaluate the prognostic implications of reduced S prime in the presence of venous congestion. |
Baseline assessment |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "155"
Final Enrollment numbers achieved (India)="155" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2024 |
| Date of Study Completion (India) |
02/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 (HF) remains a major public health concern, affecting millions of individuals worldwide and contributing significantly to morbidity, mortality, and healthcare costs. Echocardiography is the cornerstone imaging modality for evaluating cardiac structure and function in HF patients. VExUS serves as a valuable bedside tool for assessing venous congestion, utilizing measurements such as IVC diameter, hepatic vein Doppler, portal vein pulsatility, and renal vein Doppler to define venous congestion. Also it has been reported that bedside measurements can be used to assess tricuspid annular systolic velocity (S prime or S’) derived from Tissue Doppler Imaging(TDI). Hence, we propose to study the efficacy of RV function by using S’ in predicting venous congestion in heart failure patients admitted to Cardiac Critical care Unit (CCU). Additionally, our aim is to investigate the relationship between the extent of venous congestion assessed using VExUS and S’. |