Right Ventricular Function in Heart Failure

August 20, 2018 updated by: shaimaa Mostafa, Shaimaa Mostafa

Assessment Right Ventricular Systolic Function in Heart Failure With Preserved, Reduced and Mid-range Ejection Fraction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

-

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%

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
heart failure with preserved ejection fraction
Diagnostic test: echocardiography
echocardiographic assessment of the RV and LV systolic function
heart failure with mid range ejection fraction
Diagnostic test: echocardiography
echocardiographic assessment of the RV and LV systolic function
heart failure with reduced ejection fraction
Diagnostic test: echocardiography
echocardiographic assessment of the RV and LV systolic function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of the RV systolic dysfunction in patients with heart failure
Time Frame: 1.5 year
degree and prevalence of the RV systolic dysfunction in patients with heart failure with preserved, mid-range and decreased ejection fraction
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaimaa Mostafa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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