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CTRI Number  CTRI/2024/09/073984 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 27/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Telephonic follow up after hospital admission for heart failure. 
Scientific Title of Study   A pilot randomised control trial comparing telephonic message based follow up versus standard care in patients discharged after hospital admission for acute heart failure in general medical wards. 
Trial Acronym  Tel HEART study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrsivaranjaniK 
Designation  PG resident 
Affiliation  Christian medical college 
Address  Department of Medicine II, 202, Radiotherapy block, Christian Medical College hospital Ida scudder road Thottapalayam Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9626127002  
Fax    
Email  ranjanipandian92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vignesh Kumar Chandiraseharan 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Medicine II, 202, Radiotherapy block, Christian Medical College Hospital Ida Scudder road Thottapalayam Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8778879558  
Fax    
Email  vigneshmmc02@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  DrsivaranjaniK 
Designation  PG resident 
Affiliation  Christian medical college 
Address  Department of Medicine II, 202, Radiotherapy block, Christian Medical College Hospital Ida Scudder road Thottapalayam Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9626127002  
Fax    
Email  ranjanipandian92@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Fund, Office of Research, Christian Medical College,Bagayam, Vellore 632002, India 
 
Primary Sponsor  
Name  Fluid Research Fund Office of Research 
Address  Christian Medical College, Bagayam, Vellore 632002, India 
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 Sivaranjani K  Christian Medical College  Department of Medicine, Ida Scudder road Thottapalayam Vellore 632004, India
Vellore
TAMIL NADU 		 9626127002

ranjanipandian92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Office of Research, Christian Medical College, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I501||Left ventricular failure, unspecified, (2) ICD-10 Condition: I502||Systolic (congestive) heart failure, (3) ICD-10 Condition: I503||Diastolic (congestive) heart failure, (4) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure, (5) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Follow up of patients with heart failure post discharge through telephonic calls and messages.  the intervention group will receive drugs as per guideline directed medical therapy and also in addition telephonic text messages delivered by an automated messaging application at periodic intervals for first 6 weeks and a telephonic call at 6th week after randomisation.The messages have been created in accordance with American heart association and European soceity of cardiologists. The messages were sent in one ohe language -tamil/hindi/telugu/bengali/english according to patients preference. The telelephonic call aims to develop a continuing rapport with the patient during when questions on Knowlegde,attitude,practice regarding heart failure will be assesed. 
Comparator Agent  heart failure patients receiving guideline directed medical therapy.  The participants in control arm will receive the current standard of care from the treating physician.The current standard of care includes drugs including diuretics,SGLT inhibitors targeting risk factors such as Diabetes mellitus,hypertension and dyslipidemia.Those with reduced ejection fraction are managed with ACE inhibitors,beta b;lockers,mineralocorticoid receptor antagonsits.THey are given dietary adviceon salt restriction,fluid restriction,periodic monitoring of weight,compliance with medications and cardiac rehabilitation.they are advised an outpatient follow up in 2-4 weeks from date of discharge. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Those stable discharged patients with acute heart failure of ischemic etiology as diagnosed by the treating medical team entered in discharge summary

Those who provide consent. 
 
ExclusionCriteria 
Details  Heart failure patients with non ischemic etiology.
Those who are unfamiliar with mobile phone usage.
Those who didnot provide consent.
Those who are not in a stable state at time of discharge. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Composite outcome of Acute Coronary Syndrome, Stroke, All cause readmission and All cause mortality  90 days after discharge 
 
Secondary Outcome  
Outcome  TimePoints 
to compare all cause mortality at the end of 3 months among telehealth followedup patients versus standard care.  3 months 
To compare all cause readmission at the end of 3 months among telehealth followed up patients versus standard care.  3 months 
To compare major adverse cardiovascular events among telehealth followed up patients versus standard care.  3 months 
To compare patients Knowledge.Attitude practice among two arms after 3 months  3 months 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "124"
Final Enrollment numbers achieved (India)="124" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/09/2024 
Date of Study Completion (India) 02/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/06/2025 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 is one of the major causes of mortality in India. The acute cardiac conditions are mostly related to ischemia, arrhythmia, infections. The heart failure is prone for acute decompensation by any of the above inciting event and worsening the patient condition and requiring readmissions often with high risk of major adverse cardiovascular event. There are multiple studies done worldwide documenting the initial 90 days post discharge is the vulnerable period for such readmissions. Among the various causes of readmission, non compliance to drugs ,life style changes contribute the majority of cases. various studies has shown intervening by medical team at this vulnerable period causes reduction in readmissions -one such intervention is the telephonic based follow up with health guidance and monitoring after discharge. In this study. the population will be randomized  into 2 arms at discharge after acute heart failure. The control arm receiving standard care while intervention arm will receive telehealth services in the form of 6 messages each a week for 6 weeks post discharge and a call by principal investigator at 6th week along with standard of care .The intervention is aimed at improving patients adherence to drugs, diet advice, lifetsyle modifications needed thereby anticipating the prolonging the time of occurrence of major adverse cardiovascular events in the vulnerable 90 days post discharge. 
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