Frequency and Magnitude of Subclinical Systolic Dysfunction by Strain Imaging in Heart Failure With Preserved Ejection Fraction

NCT04163861 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2019-11-15

No results posted yet for this study

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 (LVEF\>50%) and evidence of diastolic dysfunction. HFpEF patients demonstrated significantly lower GLS compared to healthy controls (14.92 ± 3.16 versus 20.60 ± 1.84). The reduction in LV GLS was statistically significant (p \<0.001). Majority of patients with HFpEF (74.2%) 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 = 0.044) and also when modeled continuously (Pearson correlation, r = 0.5, p = 0.004), there was negligible correlation between LV GLS and NYHA symptom class when modeled continuously (Spearman's correlation, rs = 0.052, p = 0.789).

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.

Conditions

Interventions

DIAGNOSTIC_TEST

2d speckle tracking echocardiography

2d speckle tracking echocardiography

DIAGNOSTIC_TEST

serum BNP level

serum BNP level of HFpEF study subjects

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Mohamed Mausool Siraj, MBBS · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-05
Primary Completion
2019-10-16
Completion
2019-10-16

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163861 on ClinicalTrials.gov