| CTRI Number |
CTRI/2022/10/046656 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurence of Metabolic Syndrome in patients with Heart failure |
|
Scientific Title of Study
|
Prevalence of Metabolic Syndrome (MetS) in patients with clinical syndrome of Heart Failure with preserved Ejection Fraction (HFpEF) using H2FPEF score in a tertiary care hospital in South India-A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddarth Sadhnani |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
2nd Floor, Department of General Medicine, Kasturba Hospital, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9573557625 |
| Fax |
|
| Email |
siddarthsadhnani9@me.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siddarth Sadhnani |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
2nd Floor, Department of General Medicine, Kasturba Hospital, KMC, Manipal
KARNATAKA
576104
India |
| Phone |
9573557625 |
| Fax |
|
| Email |
siddarthsadhnani9@me.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddarth Sadhnani |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
2nd Floor, Department of General Medicine, Kasturba Hospital, KMC, Manipal
KARNATAKA
576104
India |
| Phone |
9573557625 |
| Fax |
|
| Email |
siddarthsadhnani9@me.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital
2nd Floor
Department of General Medicine
Kasturba Medical College, Manipal
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
|
|
|
Primary Sponsor
|
| Name |
KMC, Manipal |
| Address |
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
| 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 Raviraja V Acharya |
Kasturba Hospital KMC Manipal |
Department of General Medicine
2nd Floor
Kasturba Hospital
Tiger Circle Road Madhav Nagar Manipal Karnataka 576104
Udupi
KARNATAKA |
9141371000
rvacharya@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I503||Diastolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults Male and Females 18 years of age or more presenting with the clinical syndrome of heart failure and LVEF more than equal to 50% to the medicine or cardiology or emergency medicine departments of the hospital. Clinical syndrome of HFpEF will be defined according to the Framingham criteria or H2FpEF score |
|
| ExclusionCriteria |
| Details |
1. Cardiac Amyloidosis
2. Restrictive Cardiomyopathy
3. Hypertrophic Cardiomyopathy
4. Valvular Heart Disease (Moderate to severe Stenosis or Regurgitation)
5. Right Heart Failure (RV infarction, ARVC)
6. Pericardial Disease (Cardiac tamponade, Constrictive Pericarditis)
7. Obstructive Lesions in heart or great vessels (Atrial Myxoma, Pulmonary valve stenosis) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence Of Metabolic Syndrome in HFpEF patients diagnosed using H2FPEF score will be assessed |
Upto 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Epidemiology and risk factor prevalence of HFpEF in India
Correlation between H2FpEF scores and NT BNP |
Upto 3 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
27/10/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Project not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a cross sectional study to assess the prevalence of Metabolic Syndrome (MetS) in patients with clinical syndrome of Heart Failure with preserved Ejection Fraction (HFpEF) using the H2FPEF score in a tertiary care hospital in South India. The primary outcome assessed would be prevalence of Metabolic syndrome in patients with HFpEF. Other objectives would include to assess the epidemiology and risk factor prevalence of HFpEF in India, correlation between H2FpEF scores and NT BNP. |