Pulmonary HypertensionNCT03377673
Right Ventricular and Pulmonary Artery Evaluation by CMR
An observational study of Pulmonary Hypertension, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
Pulmonary hypertension results in right ventricle dysfunction. Cardiac magnetic resonance derived RV ejection fraction is a prognostic value in this condition. Right ventricular geometry, function, morphology as well as pulmonary arterial stiffness and size may be evaluated by cardiac magnetic resonance imaging and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- CMR
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jan 2012to 1 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Precapillary pulmonary hypertesnion patients
Who may be able to join
- Patient with diagnosed pulmonary hypertension
- RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
- Patients who signed study informed consent form.
Who cannot join
- Coronary and valvular heart disease
- Atrial fibrillation
- Expressed shortness of breath
- Claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right Ventricular Geometry, Function, Morphology and Pulmonary Arterial Stiffness and Size Evaluation by Cardiac Magnetic Resonance
Pulmonary hypertension results in right ventricle dysfunction. Cardiac magnetic resonance derived RV ejection fraction is a prognostic value in this condition.
Right ventricular geometry, function, morphology as well as pulmonary arterial stiffness and size may be evaluated by cardiac magnetic resonance imaging and could have great importance in evaluation of pulmonary hypertension prognosis and outcomes.
Read the detailed description
Pulmonary hypertension is defined as an increase in mean pulmonary artery pressure > 25 mmHg evaluated by right heart catheterisation. Over time increased pulmonary artery pressure eventually causes vascular remodelling and right ventricular dysfunction. The right and left ventricles interact sharing a common pericardial sac and interventricular septum. Frequently right ventricle dysfunction reflects clinical PH worsening.
The aim of this study was to assess the geometry, function and morphology of right ventricle and also pulmonary artery diameter and stiffness in pulmonary hypertension patients by cardiovascular magnetic resonance.
Patients are recruited from the Hospital of Lithuanian University of Health Sciences Kaunas clinics Pulmonary hypertension center.
Study inclusion criteria:
- Patient with diagnosed pulmonary hypertension
- RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
- Patients who signed study informed consent form.
Study exclusion criteria:
- Coronary and valvular heart disease
- Atrial fibrillation
- Expressed shortness of breath
- Claustrophobia.
Suspected number of participants - 100.
Data Analysis Statistical analyses will be performed using SPSS 22.0 package (SPSS, Chicago, IL, USA). Continuous variables will be expressed as mean +/- standard deviation, skewed variables as median (interquartile range). Chi square test will be used for qualitative parameters. For continuous variables, differences between two groups will be compared using non-parametric Mann-Whitney U test. Relation between variables will be assessed using Spearman correlation coefficient. Univariate analysis of predictors for survival will be used. In order to assess minimally false negative and minimally false positive results with greatest accuracy, the method of ROC (Receiver Operating Characteristics) curve will be used. The optimal values will be separated out the different groups (survival/non-survival) with the highest accuracy (minimal false negative and false positive). Survival curves will be established by the Kaplan-Meier estimation method. Cox regression analysis will be used to identify independent predictor of outcomes. Two-tailed probability values at p<0,05 will be considered statistically significant.
- Conditions
- Pulmonary Hypertension
- Being tested
- CMR
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
CMR is performed using a 1,5T whole-body system (Siemens Aera, Siemens Medical Solutions; Erlangen, Germany)
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricle function and morphological changes in pulmonary hypertension patients during follow up
Right ventricle function will be evaluated by CMR at base line and during follow up to find significant values for disease progression and prognosis
Measured: 2 years
Right ventricle function and morphological changes in pulmonary hypertension patients during follow up
Pulmonary artery will be evaluated by CMR at base line and during follow up to find significant values for disease progression and prognosis
Measured: 2 years
Left ventricle function and mechanical changes in pulmonary hypertension patients during follow up
Left ventricle function and mechanical changes will be evaluated by CMR and FT at base line and during follow up to find significant values for disease progression and prognosis
Measured: 2 years
Right ventricle mechanical changes in pulmonary hypertension patients during follow up
Right ventricle function and mechanical changes will be evaluated by FT at base line and during follow up to find significant values for disease progression and prognosis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2012
- Primary completion1 Feb 2017
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Egle Ereminiene, Lithuanian University of Health Sciences
- Investigators
- Lina Padervinskiene, PhD, Study director, LSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377673
- Sponsor's protocol ID
- no. BE-2-23
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Geometry, Function, Morphology and Pulmonary Arterial Stiffness and Size Evaluation by Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT03377673
- Acronym / sponsor ID
- no. BE-2-23
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 19 Dec 2017 (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.
Pulmonary hypertension results in right ventricle dysfunction. Cardiac magnetic resonance derived RV ejection fraction is a prognostic value in this condition.
Right ventricular geometry, function, morphology as well as pulmonary arterial stiffness and size may be evaluated by cardiac magnetic resonance imaging and could have great importance in evaluation of pulmonary hypertension prognosis and outcomes.
Detailed description
Pulmonary hypertension is defined as an increase in mean pulmonary artery pressure > 25 mmHg evaluated by right heart catheterisation. Over time increased pulmonary artery pressure eventually causes vascular remodelling and right ventricular dysfunction. The right and left ventricles interact sharing a common pericardial sac and interventricular septum. Frequently right ventricle dysfunction reflects clinical PH worsening.
The aim of this study was to assess the geometry, function and morphology of right ventricle and also pulmonary artery diameter and stiffness in pulmonary hypertension patients by cardiovascular magnetic resonance.
Patients are recruited from the Hospital of Lithuanian University of Health Sciences Kaunas clinics Pulmonary hypertension center.
Study inclusion criteria:
- Patient with diagnosed pulmonary hypertension
- RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
- Patients who signed study informed consent form.
Study exclusion criteria:
- Coronary and valvular heart disease
- Atrial fibrillation
- Expressed shortness of breath
- Claustrophobia.
Suspected number of participants - 100.
Data Analysis Statistical analyses will be performed using SPSS 22.0 package (SPSS, Chicago, IL, USA). Continuous variables will be expressed as mean +/- standard deviation, skewed variables as median (interquartile range). Chi square test will be used for qualitative parameters. For continuous variables, differences between two groups will be compared using non-parametric Mann-Whitney U test. Relation between variables will be assessed using Spearman correlation coefficient. Univariate analysis of predictors for survival will be used. In order to assess minimally false negative and minimally false positive results with greatest accuracy, the method of ROC (Receiver Operating Characteristics) curve will be used. The optimal values will be separated out the different groups (survival/non-survival) with the highest accuracy (minimal false negative and false positive). Survival curves will be established by the Kaplan-Meier estimation method. Cox regression analysis will be used to identify independent predictor of outcomes. Two-tailed probability values at p<0,05 will be considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Precapillary pulmonary hypertesnion patients
Key inclusion criteria (3 listed)
- Patient with diagnosed pulmonary hypertension
- RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
- Patients who signed study informed consent form.
Key exclusion criteria (4 listed)
- Coronary and valvular heart disease
- Atrial fibrillation
- Expressed shortness of breath
- Claustrophobia.
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 |
|---|---|---|
| CMRCMR is performed using a 1,5T whole-body system (Siemens Aera, Siemens Medical Solutions; Erlangen, Germany) | Diagnostic test | – |
Primary outcome
Right ventricle function and morphological changes in pulmonary hypertension patients during follow up
Time frame: 2 years
Right ventricle function will be evaluated by CMR at base line and during follow up to find significant values for disease progression and prognosis
Right ventricle function and morphological changes in pulmonary hypertension patients during follow up
Time frame: 2 years
Pulmonary artery will be evaluated by CMR at base line and during follow up to find significant values for disease progression and prognosis
Left ventricle function and mechanical changes in pulmonary hypertension patients during follow up
Time frame: 2 years
Left ventricle function and mechanical changes will be evaluated by CMR and FT at base line and during follow up to find significant values for disease progression and prognosis
Right ventricle mechanical changes in pulmonary hypertension patients during follow up
Time frame: 2 years
Right ventricle function and mechanical changes will be evaluated by FT at base line and during follow up to find significant values for disease progression and prognosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Hypertension
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
RecruitingPhase 1/2
A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
Pulmonary Arterial Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Lina Padervinskiene, PhD study director
LSMU
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 Pulmonary Hypertension, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 3 inclusion and 4 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 19 Dec 2017. 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 Lithuania. 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?
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?
Right ventricle function and morphological changes in pulmonary hypertension patients during follow up (time frame: 2 years). The study lists 4 primary outcomes in all. 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 19 Dec 2017; AzTrials last refreshed its copy on 2 Nov 2026.