| 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
|
|
|
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
|
|
|
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. |