| CTRI Number |
CTRI/2019/01/017139 [Registered on: 17/01/2019] Trial Registered Prospectively |
| Last Modified On: |
24/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of clinical and laboratory parameters in relation to heart failure |
|
Scientific Title of Study
|
Study of Clinical profile of Heart Failure and Bendopnea as a novel marker of Heart Failure |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Sreekhar |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of general medicine,2nd floor,New OPD building,Kasturba Hospital,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9030969970 |
| Fax |
|
| Email |
sreekharmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raviraja V Acharya |
| Designation |
Professor and Head Of The Unit |
| Affiliation |
Kasturba Medical College |
| Address |
Department of general medicine,2nd floor,New OPD building,Kasturba Hospital,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845471000 |
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raviraja V Acharya |
| Designation |
Professor and Head Of The Unit |
| Affiliation |
Kasturba Medical College |
| Address |
Department of general medicine,2nd floor,New OPD building,Kasturba Hospital,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845471000 |
| Fax |
|
| Email |
rvacharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Department of general medicine,2nd floor,New OPD building,Kasturba Hospital,Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| P Sreekhar |
Kasturba Hospital |
Department of general medicine, 2nd floor, New OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9030969970
sreekharmbbs@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. A known case of heart failure/Recently diagnosed with heart failure
2. BMI < 35 |
|
| ExclusionCriteria |
| Details |
1. Chronic Respiratory diseases
2. Spinal deformities
3. Unable/Not willing to bend
4. Acute Coronary Syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look if Correlation exists between various clinical(including Bendopnea), biochemical and imaging markers and severity of Heart Failure |
SEPTEMBER 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see number of hospitalizations based on severity of heart failure |
SEPTEMBER 2019 |
|
|
Target Sample Size
|
Total Sample Size="169"
Sample Size from India="169"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="163" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2019 |
| Date of Study Completion (India) |
30/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Heart failure is associated with high morbidity and mortality. Various biochemical and clinical parameters help in prognosticating patients. Bendopnea is a recent clinical manifestation found to correlate with increased morbidity and mortality. The present study aims to see if correlation exists between bendopnea and other prognostic factors. |