| CTRI Number |
CTRI/2023/04/051970 [Registered on: 25/04/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of a new tool to assess myocardial dysfunction in heart failure with preserved ejection fraction |
|
Scientific Title of Study
|
ESTIMATION OF MYOCARDIAL WORK BY ECHOCARDIOGRAPHY IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhinav Aggarwal |
| Designation |
DM SR |
| Affiliation |
VMMC and SJH |
| Address |
Heart command centre, Ground Floor, department of Cardiology, super speciality block, Safdurjung Hospital
South
DELHI
110029
India |
| Phone |
9999833130 |
| Fax |
|
| Email |
drabhinav1007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anwar Hussain Ansari |
| Designation |
Professor |
| Affiliation |
VMMC and SJH |
| Address |
Heart command centre, Ground Floor, department of Cardiology, super speciality block, Safdurjung Hospital
South
DELHI
110029
India |
| Phone |
9999833130 |
| Fax |
|
| Email |
anwarhussain72@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Abhinav Aggarwal |
| Designation |
DM SR |
| Affiliation |
VMMC and SJH |
| Address |
Heart command centre, Ground Floor, department of Cardiology, super speciality block, Safdurjung Hospital
South
DELHI
110029
India |
| Phone |
9999833130 |
| Fax |
|
| Email |
drabhinav1007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Safdarjung hospital |
| Address |
Heart command centre, Ground Floor, department of Cardiology, super speciality block, Safdurjung Hospital |
| 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 |
| Abhinav Aggarwal |
Safdurjung Hospital |
Room number 737,Department of Cardiology, super speciality block, Safdarjung Hospital, Ansari Nagar East,, New Delhi, Delhi 110029
South
DELHI |
9999833130
drabhinav1007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board/Thesis protocol review committee Safdurjung Hospital |
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
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with unexplained dyspnea or fatigue with LV ejection fraction of more than or equal
to 50% on transthoracic echocardiography with no apparent cause of HF symptoms other than
HFpEF
2) Age ≥ 35 years |
|
| ExclusionCriteria |
| Details |
1) Significant valvular disease: severe AS,AR,MS,MR
2) Pericardial diseases
3) Prosthetic heart valve or prosthetic ring
4) Obstructive heart lesions(myxomas)
5) Congenital heart disease
6) Severe anaemia
7) Severe COPD
8) Poor acoustic window |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
myocardial work by echocardiography in patients with heart failure with preserved
ejection fraction. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
correlation of myocardial work and global longitudinal strain(GLS) with NT Pro
BNP levels and pulmonary capillary wedge pressure(PCWP). |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/05/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Heart failure (HF) is defined as the inability of the heart to pump blood to the body at a rate
commensurate with its needs, or to do so only at the cost of high filling pressures. The new
guidelines classify patients with HF in three categories: heart failure with preserved ejection
fraction (HFpEF), defined by an LVEF ≥50%, heart failure with reduced ejection fraction (HFrEF)
if the LVEF is <40%, and heart failure with mid-range ejection fraction (HFmrEF) if the LVEF is 40–
49%. Patients with heart failure are at a higher risk for subsequent repeat exacerbations of
symptoms requiring hospitalization as well as cardiovascular death.
The reference gold standard to diagnose HFpEF in patients is right-sided heart catheterization
followed by invasive exercise testing if resting intracardiac pressures are normal. Patients with
HFpEF are identified by elevated pulmonary capillary wedge pressure at rest (≥15 mm Hg) or
during exercise (≥25 mm Hg)
.
Research suggests that LV systolic reserve disturbances may lead to the reduction of exercise
capacity in patients with HFpEF. Traditional measurement of Left ventricular performance with
ejection fraction (EF) is notably subjective, with many limitations and interobserver variability,
while tissue Doppler Imaging has technical issues including preload and afterload dependence,
and limitations in its ability to assess all planes of LV deformation. Recently, echocardiography
parameters like speckle tracking imaging with global longitudinal strain (GLS) is being used to
assess subtle myocardial dysfunction as this is a more objective measure but this too remains
limited by its load dependency, as increase in the afterload may decrease the GLS and lead to
false interpretations about LV contractility.
To overcome these issues, a new echocardiographic tool called myocardial work (MW) has been
developed to non-invasively measure the LV pressure–strain relationship. MW is calculated as
LV pressure applied over strain and is a non-invasive method for LV performance evaluation. It
incorporates both LV afterload and deformation. MW analysis is less load-dependent if
compared with global longitudinal strain, and therefore could provide incremental information
in the setting of HF patients. Thus, myocardial work is affected earlier as compared to global
longitudinal strain. It is estimated by employing non-invasive brachial artery blood pressure and
LV GLS. The estimated LV pressure curve is calculated using an empiric reference pressure curve.
Along with MW, its components are also calculated, namely: global work index (GWI), global
work efficiency (GWE), global constructive work (GCW) and global wasted work (GWW).
Despite MW being an index of LV performance, there have only been a few studies of MW In
HFpEF patients. These studies have shown that these patients have impaired GLS, enhanced WW
and reduced myocardial work efficiency (MWE). MW analysis has been suggested to help
differentiate patients with impending LV systolic decompensation. Research has also shown that
low GWI is a predictor of severely impaired LV function, inadequate cardiopulmonary exercise,
and increased NT-proBNP levels, all of which are markers of poor prognosis. They concluded that
in HFpEF patients, GWW showed high accuracy to predict the first HFpEF hospitalization and its
association with mortality. In addition, preclinical subtle myocardial damage in HFpEF could
potentially be detected by MW.
Despite the enormity of this subject, there have been a very small number of studies worldwide
and none at all in India about the role of myocardial work in patients with HFpEF. Despite
extensive search of literature, we could not find any study on the correlation between
myocardial work parameters and the gold standard of HFpEF diagnosis, i.e pulmonary capillary
wedge pressure. This avenue has the potential to alter algorithms for the prevention,
investigation, diagnosis, treatment and follow up of patients with HFpEF, highlighting the need
for future large research in this field.
AIM
To evaluate myocardial work indices and global longitudinal strain by echocardiography in
patients with Heart failure with preserved ejection fraction.
Primary objective:
To evaluate myocardial work by echocardiography in patients with heart failure with preserved
ejection fraction.
Secondary objective:
To study the correlation of myocardial work and global longitudinal strain(GLS) with NT Pro
BNP levels and pulmonary capillary wedge pressure(PCWP).
|