| CTRI Number |
CTRI/2025/03/082717 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing heart failure tests that best predict heart problems |
|
Scientific Title of Study
|
Assessment of the predictive value of BNP/ NT-proBNP Thresholds vs NT-proBNP with and without Acute Heart Failure Cases. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind kumar kushwaha |
| Designation |
Phd scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, ground floor, JNMC building, Sawangi Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9981860352 |
| Fax |
|
| Email |
kumararvind2484@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Anjankar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, ground floor, JNMC building, Sawangi Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9423108367 |
| Fax |
|
| Email |
ashish.anjankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Anjankar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, ground floor, JNMC building, Sawangi Meghe
MAHARASHTRA
442107
India |
| Phone |
9423108367 |
| Fax |
|
| Email |
ashish.anjankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha, India 442107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha, India 442107 |
| Type of Sponsor |
Private medical college |
|
|
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 Arvind Kumar Kushwaha |
Acharya Vinoba Bhave Rural Hospital |
Centrol Clinical Laboratory, AVBRH, Campus, Sawangi Meghe
Wardha
MAHARASHTRA |
9981860352
kumararvind2484@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I508||Other heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. The Age criteria of patients is above 30 years.
2. Indian citizen.
3. Acute heart failure cases, according to Framingham Diagnostic Criteria, one major and two minor criteria symptoms are found in patients within six weeks, with physical examination and echocardiography.
4. The Ability for the patients to provide a written consent form.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant patients will be excluded
2. Chronic Kidney disease
3. Chronic Alcoholics
4. Liver disease
5. Cancer patients
6. Malignancy
7. Patients who are not willing to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A predictive biomarker that is simple to use to detect acute Heart Failure. |
Assessment will be done at the time of admission after 24 hrs. overall study assessment will be done within 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/04/2025 |
| 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="3"
Months="0"
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
|
Background:
Diagnosis and treatment of acute heart
failure (AHF) is an important task for cardiologists. Diagnostic tests include
biomarkers such as N-terminal B-type natriuretic peptide (NT-proBNP) and brain
natriuretic peptide (BNP). Comparison of BNP/NT-proBNP thresholds in AHF and
non-AHF patients may aid in diagnosis.
Objective:
We sought to evaluate the predictive
utility of NT-proBNP and BNP/NT-proBNP thresholds in patients with and without HF.
This study evaluated and compared the predictive ability of serial NT-proBNP
measurements and BNP/NT-proBNP threshold in patients with and without heart
failure.
Methods:
A cross-sectional study will include 50
patients hospitalized at Acharya Vinoba Bhave Rural Hospital and Jawaharlal
Nehru Medical College and 50 controls. These will include patients with and
without severe HF. Data on BNP and NT-proBNP levels and clinical outcomes will
be collected. |