Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease

June 29, 2022 updated by: Muhammad Khidr Ezzat thabet, Assiut University
NPs can be used To detect subset of asymptomatic with subtle LV dysfunction for further evaluation and earlier referral for intervention and its correlation with echocardiographic finding.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Each patient included in the study will undergo:

  1. History taking:

    Analysis of patient symptoms and signs (dyspnea , orthopnea , Paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,…etc )

  2. Clinical examination:

    • Detecion of each patient body weight , height , calculation of BMI.
    • General examination for detection of signs of Heart failure (raised JVP , lower limb edema, ..etc)
    • Examination to respiratory system
    • Auscultation of the heart for detection of valvular affection before echocardiography

Invesigations:

Laboratory investigations:

Urea and creatinine . b) ECG : for exclusion of atrial fibrillation and other arrythmias. 2D Transthorathic Echocardiography (TTE) Evaluation of valve morphology and thickness , gradients and valve area , regurgitant lesions and its severity.

Evaluation of internal cardiac dimensions and function. 5- Natriuretic peptides: as a useful screening tool to differentiate symptomatic and asymptomatic patients.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University ,faculty of medicine

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the study will include consecutive eligible patients recruited in assiut university hospital

Description

Inclusion Criteria:

  • All patients echocardiographically diagnosed with significant valve lesions. Rheumatic Heart disease with significant but asymptomatic valvular Heart Disease especially (Mitral valve disease )(MS and MR) Gender: male & female

Exclusion Criteria:

  • Cases with increased level of BNP as in :

Renal impairment Advanced age and obesity Atrial fibrillation and acute coronary syndromes Prior lung diseases and acute illness

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

  • Observational Models: Case-Control
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early detection of subclinical LV dysfunction.
Time Frame: 1 year
early detection of subclinical LV dysfunction.
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed Aly Abdelhafez, Lecturer, Assiut University

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 (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPs in Valvular heart diseases

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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