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CTRI Number  CTRI/2023/06/054583 [Registered on: 30/06/2023] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Comparative Study Of Frality Syndrome In Patients With Heart Failure With Preserved VS Reduced Ejection Fraction  
Scientific Title of Study   A Comparative Evaluation Of Frality Syndrome In Heart Failure With Preserved VS Reduced Ejection Fraction 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srishti Mukhi 
Designation  Junior Resident  
Affiliation  Guru Gobind Singh Medical College Faridkot Punjab  
Address  Department Of Medicine Guru Gobind Singh Medical College Faridkot Punjab

Faridkot
PUNJAB
142049
India 
Phone  9582686388  
Fax    
Email  srishtimukhi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Ravinder Garg 
Designation  Professor  
Affiliation  Guru Gobind Singh Medical College Faridkot Punjab  
Address  Department of Medicine Guru Gobind Singh Medical College Faridkot Punjab
Guru Gobind Singh Medical College Faridkot Punjab
Faridkot
PUNJAB
142049
India 
Phone  9582686388  
Fax    
Email  drravindergarg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Srishti Mukhi 
Designation  Junior Resident  
Affiliation  Guru Gobind Singh Medical College Faridkot Punjab  
Address  Department of Medicine Guru Gobind Singh Medical College Faridkot Punjab
Guru Gobind Singh Medical College Faridkot Punjab
Faridkot
PUNJAB
142049
India 
Phone  9582686388  
Fax    
Email  srishtimukhi@gmail.com  
 
Source of Monetary or Material Support  
Department of Medicine Guru Gobind Singh Medical College Faridkot Punjab 14209 
 
Primary Sponsor  
Name  Dr Srishti Mukhi Department of Medicine  
Address  Guru Gobind Singh Medical College Faridkot Punjab 151203 
Type of Sponsor  Government medical college 
 
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 
DrSrishti Mukhi  Guru Gobind Singh medical College   Department of Medicine Guru Gobind Singh medical College faridkot
Faridkot
PUNJAB 
9582686388

srishtimukhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THESIS & ETHICS COMMITTEE G.G.S. MEDICAL COLLEGE & HOSPITAL, FARIDKOT  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 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects aged 40-65 years of either gender with heart failure. 
 
ExclusionCriteria 
Details  1.Patients with chronic kidney disease (CKD), chronic liver disease (CLD), bronchial asthma and COPD.
2.Patients with stroke, dementia, neuromuscular disorders
3.Patients with malignancies.
4.Patients suffering from HIV-AIDS.
5.Patients with hypothyroidism.
6.Immunocompromised patients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.FRIED FRALITY INDEX IN HEART FAILURE
2.COMPARISSION OF FRIED FRALITY INDEX BETWEEEN HEART FAILURE WITH PRESERVED AND REDUCED EJECTION FRACTION
 
BASELINE 
 
Secondary Outcome  
Outcome  TimePoints 
SEVERITY OF DISEASE  AT THE END OF 1 YEAR AND 6 MONTHS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2023 
Date of Study Completion (India) 15/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
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
Modification(s)  

Background: Heart failure (HF) is a leading cause of cardiovascular morbidity and mortality, with a global prevalence that increases significantly with age. In India, HF is primarily associated with coronary heart disease, hypertension, obesity, diabetes mellitus (DM), and rheumatic heart disease. HF is categorized into three phenotypes based on left ventricular ejection fraction (LVEF): HF with reduced ejection fraction (HFREF), HF with preserved ejection fraction (HFPEF), and HF with mid-range ejection fraction (HFmrEF). Frailty, a syndrome characterized by decreased physiological reserves, commonly coexists with HF, exacerbating its clinical outcomes.

 

Objectives: This study aimed to estimate the prevalence of frailty syndrome in patients with HFPEF and HFREF and to compare the prevalence between these two groups.

 

Methods: A hospital-based comparative study was conducted over 18 months at Guru Gobind Singh Medical College & Hospital, Faridkot, involving 100 HF patients aged 40-65 years. Participants were divided equally into HFPEF and HFREF groups. Frailty was assessed using the Fried Frailty Index, which evaluates five criteria: weight loss, exhaustion, low physical activity, weak hand grip strength, and slow walking speed.  The sum score of these five criteria classifies people into one of three frailty stages (or groups): not frail (score 0), pre frail (score 1–2) and frail (score 3-5).Statistical analysis was performed using SPSS version 26, with significance set at p <0.05.

 

Results: The study found that 42% of patients were pre-frail, and 36% were frail, indicating that the majority (78%) exhibited some degree of frailty. Frailty was significantly more prevalent in HFREF patients (46%) compared to HFPEF patients (26%) (p=0.037). Females in the HFREF group were more likely to be frail than males (p=0.008). DM was significantly associated with frailty in the HFPEF group (p=0.024), but not in the HFREF group. Factors such as BMI, hypertension, HF etiology, symptomatology, and echocardiographic findings showed no significant association with frailty. However, significant associations were found between frailty and individual components of the Fried Frailty Index, such as weight loss, slow walking speed, exhaustion, weak hand grip strength, and low physical activity, but they did not differ significantly between the two groups of heart failure. However, the composite score of all these components contributing to the Fried Frailty Index significantly differed between the two groups.

Conclusion: Frailty is highly prevalent among HF patients, particularly in those with HFREF. The study highlights the importance of assessing frailty using simple bedside parameters to guide targeted interventions, which may improve clinical outcomes. Further research is required to explore the interplay between frailty and HF to optimize management strategies.

 
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