NCT03641599

Brief Summary

Only a few studies evaluated the RV systolic function in the three categories of HF, regarding the importance of understanding changes in RV function on clinical presentation and outcome; it was essential to understand the prevalence and severity of RV dysfunction among the three groups and the degree of correlation between RV with LV systolic function.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

August 17, 2018

Last Update Submit

August 20, 2018

Conditions

Keywords

RV systolic functionHFpEFHFmrEFHFrEF

Outcome Measures

Primary Outcomes (1)

  • assessment of the RV systolic dysfunction in patients with heart failure

    degree and prevalence of the RV systolic dysfunction in patients with heart failure with preserved, mid-range and decreased ejection fraction

    1.5 year

Study Arms (3)

heart failure with preserved ejection fraction

Diagnostic Test: echocardiography

heart failure with mid range ejection fraction

Diagnostic Test: echocardiography

heart failure with reduced ejection fraction

Diagnostic Test: echocardiography

Interventions

echocardiographyDIAGNOSTIC_TEST

echocardiographic assessment of the RV and LV systolic function

heart failure with mid range ejection fractionheart failure with preserved ejection fractionheart failure with reduced ejection fraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HFpEF\>50%, HFrEF\<40% and HFmrEF \>40% and \<50%

You may qualify if:

  • Adult patients of both gender who have the followiong criteria :
  • (i) symptoms with or without signs of HF (ii) elevated natriuretic peptides (BNP ≥35pg/ mL or NT-proBNP≥125pg/mL) (iii) relevant structural heart disease: left ventricle hypertrophy (left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or left atrial enlargement (\>34 mL/m2) or diastolic dysfunction (E/e'≥13 and a mean e' septal and lateral wall \<9 cm/s) were included.
  • Then patients were classified according to EF into HFpEF\>50%, HFrEF\<40% and HFmrEF \>40% and \<50%

You may not qualify if:

  • Patients with chronic obstructive pulmonary disease history of pulmonary embolism patients with respiratory failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mostafa S. Assessment of right ventricular systolic function in heart failure with preserved, reduced and mid-range ejection fraction. Indian Heart J. 2019 Sep-Oct;71(5):406-411. doi: 10.1016/j.ihj.2019.11.252. Epub 2019 Nov 20.

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor of cardiovascular medicicne

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 22, 2018

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08