Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04163861
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2019-03-22
Brief Title:
Frequency and Magnitude of Subclinical Systolic Dysfunction by Strain Imaging in Heart Failure With Preserved Ejection Fraction
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Frequency and Magnitude of Sub-clinical Systolic Dysfunction by Strain Imaging in Heart Failure With Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Originally thought to be purely due to LV diastolic dysfunction studies in western countries have suggested that heart failure with preserved ejection fraction HFpEF is more complex In patients with HFpEF LV systolic function is commonly considered normal as the global ejection fraction EF is normal However the EF reflects only the global cardiac contractile function and does not take the subclinical systolic function into consideration Therefore more attention should be paid on this subset of heart failure population in which the frequency and magnitude of concomitant subclinical systolic dysfunction has not been clearly defined
Objective The principal objective of this study was to assess the global longitudinal systolic function of the LV in patients with HFpEF in a tertiary level hospital with the aim of finding out the frequency and magnitude of impaired subclinical systolic dysfunction by using Global Longitudinal Strain GLS derived from 2D speckle tracking echocardiography and to see if there is any correlation of GLS with New York Heart Association NYHA functional class and BNP level in these patients
Methods This was a cross-sectional study conducted from May 2018 to April 2019 A total of 31 patients with HFpEF Group I and 31 healthy volunteers of similar age and sex Group II were enrolled in the study by consecutive sampling Detailed history including NYHA functional class physical examination relevant investigations including BNP level was done in patients with HFpEF 2D echocardiography color Doppler tissue Doppler and 2D speckle tracking echocardiography was done in both groups GLS was obtained in a total of 31 patients with HFpEF Group I diagnosed according to the 2016 European Society of Cardiology ESC guidelines for the diagnosis and treatment of acute and chronic heart failure and compared with GLS of 31 healthy volunteers Group II to find out the frequency and magnitude of impaired subclinical systolic function in patients with HFpEF GLS was also compared with their NYHA functional class and BNP level to find out if any significant relationship is present
Result All patients with HFpEF had preserved LV ejection fraction LVEF50 and evidence of diastolic dysfunction HFpEF patients demonstrated significantly lower GLS compared to healthy controls 1492 316 versus 2060 184 The reduction in LV GLS was statistically significant p 0001 Majority of patients with HFpEF 742 had reduced GLS when reduced GLS was defined as 2SD below the mean value for healthy volunteers indicating the presence of subclinical systolic dysfunction in majority of these patients Worse GLS was associated with higher BNP levels in patients with HFpEF when modeled categorically as quartiles p 0044 and also when modeled continuously Pearson correlation r 05 p 0004 there was negligible correlation between LV GLS and NYHA symptom class when modeled continuously Spearmans correlation rs 0052 p 0789
Conclusion Strain imaging detects impaired systolic function despite preserved global EF in patients with HFpEF Subclinical systolic dysfunction was frequent in the majority of HFpEF patients Lower LV GLS is associated with higher BNP level LV GLS was not associated with NYHA functional class Further large scale studies are recommended to confirm the findings of this study
Objective The principal objective of this study was to assess the global longitudinal systolic function of the LV in patients with HFpEF in a tertiary level hospital with the aim of finding out the frequency and magnitude of impaired subclinical systolic dysfunction by using Global Longitudinal Strain GLS derived from 2D speckle tracking echocardiography and to see if there is any correlation of GLS with New York Heart Association NYHA functional class and BNP level in these patients
Methods This was a cross-sectional study conducted from May 2018 to April 2019 A total of 31 patients with HFpEF Group I and 31 healthy volunteers of similar age and sex Group II were enrolled in the study by consecutive sampling Detailed history including NYHA functional class physical examination relevant investigations including BNP level was done in patients with HFpEF 2D echocardiography color Doppler tissue Doppler and 2D speckle tracking echocardiography was done in both groups GLS was obtained in a total of 31 patients with HFpEF Group I diagnosed according to the 2016 European Society of Cardiology ESC guidelines for the diagnosis and treatment of acute and chronic heart failure and compared with GLS of 31 healthy volunteers Group II to find out the frequency and magnitude of impaired subclinical systolic function in patients with HFpEF GLS was also compared with their NYHA functional class and BNP level to find out if any significant relationship is present
Result All patients with HFpEF had preserved LV ejection fraction LVEF50 and evidence of diastolic dysfunction HFpEF patients demonstrated significantly lower GLS compared to healthy controls 1492 316 versus 2060 184 The reduction in LV GLS was statistically significant p 0001 Majority of patients with HFpEF 742 had reduced GLS when reduced GLS was defined as 2SD below the mean value for healthy volunteers indicating the presence of subclinical systolic dysfunction in majority of these patients Worse GLS was associated with higher BNP levels in patients with HFpEF when modeled categorically as quartiles p 0044 and also when modeled continuously Pearson correlation r 05 p 0004 there was negligible correlation between LV GLS and NYHA symptom class when modeled continuously Spearmans correlation rs 0052 p 0789
Conclusion Strain imaging detects impaired systolic function despite preserved global EF in patients with HFpEF Subclinical systolic dysfunction was frequent in the majority of HFpEF patients Lower LV GLS is associated with higher BNP level LV GLS was not associated with NYHA functional class Further large scale studies are recommended to confirm the findings of this study
Detailed Description:
Case All patients presented with the diagnosis of heart failure with preserved ejection fraction HFpEF to Department of Cardiology BSMMU were initially approached and then selected as case on the basis of inclusion and exclusion criteria Heart failure diagnosis was made according to the 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure All inclusion criteria were established within 24 hours of presentation The eligible patients were explained about the study written informed consent was taken and demographic data were recorded
Control group Apparently normal healthy volunteers were initially approached Medical records were reviewed for prevalent cardiovascular disease stroke coronary artery disease heart failure arrhythmia cardiovascular risk factors hypertension diabetes mellitus hyperlipidemia smoking renal dysfunction systemic disease such as cancer infections autoimmune disorders or any pharmacotherapy Subjects were excluded if any of these were identified The eligible patients were explained about the study Written informed consent was taken and demographic data Pulse blood pressure and respiratory rate were recorded
Clinical data including detailed medical history cardiovascular risk factors and associated comorbidities of patients with HFpEF were noted Relevant physical examination was done and recorded in semi-structured designed data collection sheet Complementary data were collected including chest radiography ECG Echocardiography and relevant laboratory tests The symptoms of patients were noted Shortness of breath was graded according to NYHA functional classification Venous blood samples were collected in plastic vacuum tubes at room temperature for analysis of BNP using chemilumunescent micro particle immunoassay CMIA on the ARCHITECT iSystem on day 1 of presentation in HFpEF cases Other laboratory investigations including hemoglobin serum creatinine HbA1c in diabetics were also done
Echocardiography was performed by using Vivid E9 GE Healthcare Norway using a 35 Mhz transducer ECG leads were connected before analysis LV diameters were calculated by M-mode and LVEF by Simpsons modified biplane method The LV mass was estimated by using the area length method and adjusted for body surface area Echocardiographic LV hypertrophy was defined as an LV mass index 115 gm2 for men and 95 gm2 for women LV geometry was classified based on relative wall thickness RWT defined as 2diastolic posterior wall thicknessLV end-diastolic dimension and Left Ventricular Mass Index LVMi as recommended by the American Society of Echocardiography ASE normal RWT 042 and no LVH eccentric hypertrophy RWT 042 and LVH concentric remodeling RWT 042 and no LVH concentric hypertrophy RWT 042 and LVH Right ventricular RV function was assessed by tricuspid annular plane systolic excursion TAPSE and tricuspid lateral annular systolic velocity S by pulsed tissue Doppler Peak pulmonary arterial systolic pressure PASP was estimated as the sum of peak RV-right atrial gradient from the tricuspid valve regurgitant jet and right atrial pressure on the basis of size and collapsibility of inferior vena cava Presence and severity of valvular heart diseases were assessed by color Doppler imaging and image guided pulsed and continuous Doppler studies according to 2014 AHAACC Guidelines for the Management of Patients with Valvular Heart Disease Patients with more than mild valvular heart diseases were excludedDiastolic function parameters were measured as follows peak early diastolic filling E and late diastolic filling A velocities EA ratio E deceleration time early diastolic septal and lateral mitral annular velocity e average EE peak TR jet velocity left atrial volume index Left atrial volume index was calculated using biplane area-length method from apical four and two chamber views at end-systole from the frame preceding mitral valve opening and was indexed to body surface area Diastolic dysfunction was classified into three grades according to 2016 ASEEACVI guidelines
LV longitudinal strains were analyzed by 2D speckle tracking echocardiography for both controls and patients with HFpEF Cardiac cycles were obtained during a breath hold in end-expiration Special care was taken to obtain correct view and checking for foreshortening Endocardial border was traced at end systole with a frame rate of 50-80second from apical long axis four chambers and two-chambers view In case of poor tracking region of interest ROI was readjusted The results of all three planes were combined in a single bulls eye summary along with a global longitudinal strain value GLS for the LV which was automatically calculated by automated function imaging AFI All strain analysis on HFpEF and normal control subjects was be performed by a single investigator Two independent investigators analyzed the echocardiography recordings blinded to clinical data The intra-observer and inter-observer variability of GLS was assessed from 10 randomly selected patients by intra-class correlation coefficientR The R value for intra-observer variability was 0983 and for inter-observer variability was 0980 This showed good reproducibility of GLS for both same and different operators
Control group Apparently normal healthy volunteers were initially approached Medical records were reviewed for prevalent cardiovascular disease stroke coronary artery disease heart failure arrhythmia cardiovascular risk factors hypertension diabetes mellitus hyperlipidemia smoking renal dysfunction systemic disease such as cancer infections autoimmune disorders or any pharmacotherapy Subjects were excluded if any of these were identified The eligible patients were explained about the study Written informed consent was taken and demographic data Pulse blood pressure and respiratory rate were recorded
Clinical data including detailed medical history cardiovascular risk factors and associated comorbidities of patients with HFpEF were noted Relevant physical examination was done and recorded in semi-structured designed data collection sheet Complementary data were collected including chest radiography ECG Echocardiography and relevant laboratory tests The symptoms of patients were noted Shortness of breath was graded according to NYHA functional classification Venous blood samples were collected in plastic vacuum tubes at room temperature for analysis of BNP using chemilumunescent micro particle immunoassay CMIA on the ARCHITECT iSystem on day 1 of presentation in HFpEF cases Other laboratory investigations including hemoglobin serum creatinine HbA1c in diabetics were also done
Echocardiography was performed by using Vivid E9 GE Healthcare Norway using a 35 Mhz transducer ECG leads were connected before analysis LV diameters were calculated by M-mode and LVEF by Simpsons modified biplane method The LV mass was estimated by using the area length method and adjusted for body surface area Echocardiographic LV hypertrophy was defined as an LV mass index 115 gm2 for men and 95 gm2 for women LV geometry was classified based on relative wall thickness RWT defined as 2diastolic posterior wall thicknessLV end-diastolic dimension and Left Ventricular Mass Index LVMi as recommended by the American Society of Echocardiography ASE normal RWT 042 and no LVH eccentric hypertrophy RWT 042 and LVH concentric remodeling RWT 042 and no LVH concentric hypertrophy RWT 042 and LVH Right ventricular RV function was assessed by tricuspid annular plane systolic excursion TAPSE and tricuspid lateral annular systolic velocity S by pulsed tissue Doppler Peak pulmonary arterial systolic pressure PASP was estimated as the sum of peak RV-right atrial gradient from the tricuspid valve regurgitant jet and right atrial pressure on the basis of size and collapsibility of inferior vena cava Presence and severity of valvular heart diseases were assessed by color Doppler imaging and image guided pulsed and continuous Doppler studies according to 2014 AHAACC Guidelines for the Management of Patients with Valvular Heart Disease Patients with more than mild valvular heart diseases were excludedDiastolic function parameters were measured as follows peak early diastolic filling E and late diastolic filling A velocities EA ratio E deceleration time early diastolic septal and lateral mitral annular velocity e average EE peak TR jet velocity left atrial volume index Left atrial volume index was calculated using biplane area-length method from apical four and two chamber views at end-systole from the frame preceding mitral valve opening and was indexed to body surface area Diastolic dysfunction was classified into three grades according to 2016 ASEEACVI guidelines
LV longitudinal strains were analyzed by 2D speckle tracking echocardiography for both controls and patients with HFpEF Cardiac cycles were obtained during a breath hold in end-expiration Special care was taken to obtain correct view and checking for foreshortening Endocardial border was traced at end systole with a frame rate of 50-80second from apical long axis four chambers and two-chambers view In case of poor tracking region of interest ROI was readjusted The results of all three planes were combined in a single bulls eye summary along with a global longitudinal strain value GLS for the LV which was automatically calculated by automated function imaging AFI All strain analysis on HFpEF and normal control subjects was be performed by a single investigator Two independent investigators analyzed the echocardiography recordings blinded to clinical data The intra-observer and inter-observer variability of GLS was assessed from 10 randomly selected patients by intra-class correlation coefficientR The R value for intra-observer variability was 0983 and for inter-observer variability was 0980 This showed good reproducibility of GLS for both same and different operators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None