FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105224 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal Observational Study 
Study Design  Other 
Public Title of Study   Can a Blood Test Predict Outcomes in Patients with Heart Failure with Normal Pumping Function 
Scientific Title of Study   To Study Serum Chromogranin A Levels in Heart Failure with Preserved Ejection Fraction as a Prognostic Marker – A Longitudinal Observational 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. Rekha S Patil 
Designation  Head of Department, General Medicine 
Affiliation  JNMC BELAGAVI 
Address  Department of General Medicine, JNMC KLE University Campus
Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India 
Phone  9448371125  
Fax    
Email  drrekhaspatil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rekha S Patil 
Designation  Head of Medicine 
Affiliation  JNMC BELAGAVI 
Address  Department of General Medicine, JNMC
Nehru Nagar, Belagavi, Karnataka 590010

KARNATAKA
590010
India 
Phone  9448371125  
Fax    
Email  drrekhaspatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vineet Patil 
Designation  GENERAL MEDICINE JR2 
Affiliation  JNMC BELAGAVI 
Address  Department of General Medicine, JNMC
Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India 
Phone  7020924142  
Fax    
Email  drvineetpatil@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  JNMC BELAGAVI 
Address  VGJ7MPQ JNMC Campus, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010 
Type of Sponsor  Research institution and hospital 
 
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 Vineet Patil  KAHER’s Jawaharlal Nehru Medical College, Belagavi  Department of General Medicine, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA 		 7020924142

drvineetpatil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I503||Diastolic (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  Diagnosed HFpEF
2D Echo EF 50% or more
NTproBNP more than 300 pg/ml
Provided informed consent 
 
ExclusionCriteria 
Details  Chronic Kidney Disease

Chronic Liver Disease

Neuroendocrine tumors 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Composite outcome of heart failure–related readmission or all-cause mortality within 6 months.  Composite outcome of heart failure–related readmission or all-cause mortality at 2, 4 and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Incremental predictive value of CGA over NT-proBNP  at 2, 4 & 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/03/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvineetpatil@gmail.com].

  6. For how long will this data be available start date provided 13-06-2027 and end date provided 13-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

  • Heart Failure with Preserved Ejection Fraction (HFpEF) lacks robust prognostic biomarkers.

  • Chromogranin A (CgA) reflects sympathetic activation and myocardial neurohormonal stress.

  • This study evaluates:

    • Prognostic significance of serum CgA in HFpEF

    • Incremental value over NTproBNP

  • 80 HFpEF patients will be followed for 6 months.

  • Primary outcomes: Readmission and Mortality.

  • Statistical evaluation using ROC analysis and multivariate regression.

  • Aim: To determine whether CgA can improve risk stratification in HFpEF.

 
Close