Valvular Heart Disease Stenosis and RegurgitationNCT05439369
Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease
An observational study of Valvular Heart Disease Stenosis and Regurgitation, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease Stenosis and Regurgitation
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study will include consecutive eligible patients recruited in assiut university hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University ,faculty of medicine
Asyut
About this study
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.
Read the detailed description
Each patient included in the study will undergo:
- History taking: Analysis of patient symptoms and signs (dyspnea , orthopnea , Paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,…etc )
- 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.
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
early detection of subclinical LV dysfunction.
early detection of subclinical LV dysfunction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart Disease Stenosis and RegurgitationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Khidr Ezzat thabet, Assiut University
- Investigators
- Mohamed Aly Abdelhafez, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439369
- Sponsor's protocol ID
- NPs in Valvular heart diseases
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease
- ClinicalTrials.gov ID
- NCT05439369
- Acronym / sponsor ID
- NPs in Valvular heart diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each patient included in the study will undergo:
- History taking: Analysis of patient symptoms and signs (dyspnea , orthopnea , Paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,…etc )
- 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 design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study will include consecutive eligible patients recruited in assiut university hospital
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
early detection of subclinical LV dysfunction.
Time frame: 1 year
early detection of subclinical LV dysfunction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Related trials for Valvular Heart Disease Stenosis and Regurgitation
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
RecruitingObservational study
Prospective Evaluation of AI-ECG for SHD Detection
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Aly Abdelhafez, Lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease Stenosis and Regurgitation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad KE thabet, resident (01150713889, muhammadkhidr147@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early detection of subclinical LV dysfunction. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.