Assessment of the RV Function in Patients With Heart FaliureNCT03641599
Right Ventricular Function in Heart Failure
An observational study of Assessment of the RV Function in Patients With Heart Faliure, run by shaimaa Mostafa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assessment of the RV Function in Patients With Heart Faliure
- What is being tested?
- echocardiography
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HFpEF>50%, HFrEF<40% and HFmrEF >40% and <50%
Who may be able to join
- -
- Adult patients of both gender who have the followiong criteria :
- 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%
Who cannot join
- Patients with chronic obstructive pulmonary disease history of pulmonary embolism patients with respiratory failure
About this study
Official title: 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.
- Being tested
- echocardiography
- Keywords
- RV systolic function, HFpEF, HFmrEF, HFrEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic test
echocardiographic assessment of the RV and LV systolic function
| Study group | Role | What they receive |
|---|---|---|
| heart failure with preserved ejection fraction | Not described Receives: Diagnostic Test: echocardiography | |
| heart failure with mid range ejection fraction | Not described Receives: Diagnostic Test: echocardiography | |
| heart failure with reduced ejection fraction | Not described Receives: Diagnostic Test: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Jan 2017
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Assessment of the RV Function in Patients With Heart FaliureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- shaimaa Mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, shaimaa Mostafa, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641599
- Sponsor's protocol ID
- RV
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32035524
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Right Ventricular Systolic Function in Heart Failure With Preserved, Reduced and Mid-range Ejection Fraction
- ClinicalTrials.gov ID
- NCT03641599
- Acronym / sponsor ID
- RV
- Keywords
- RV systolic function, HFpEF, HFmrEF, HFrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- shaimaa MostafaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 22 Aug 2018 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HFpEF>50%, HFrEF<40% and HFmrEF >40% and <50%
Key inclusion criteria (4 listed)
- -
- 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%
Key exclusion criteria (1 listed)
- Patients with chronic obstructive pulmonary disease history of pulmonary embolism patients with respiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyechocardiographic assessment of the RV and LV systolic function | Diagnostic test | heart failure with mid range ejection fraction, heart failure with preserved ejection fraction, heart failure with reduced ejection fraction |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 32035524Mostafa 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of the RV Function in Patients With Heart Faliure, run by shaimaa Mostafa.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the RV systolic dysfunction in patients with heart failure (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641599, which also lists 1 linked publication.
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 22 Aug 2018.