Right Ventricular and Pulmonary Artery Evaluation by CMR

• Conditions: Pulmonary Hypertension

• Registration Number: NCT03377673
• Lead Sponsor: Lithuanian University of Health Sciences

Brief 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 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:

1. Patient with diagnosed pulmonary hypertension

2. RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.

3. Patients who signed study informed consent form.

Study exclusion criteria:

1. Coronary and valvular heart disease

2. Atrial fibrillation

3. Expressed shortness of breath

4. 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 Timeline

• Study Start: 2012-01-01
• Primary Completion: 2017-02-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Study First Posted: 2017-12-19
• Last Update Posted: 2017-12-19
• Study Completion: 2018-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patient with diagnosed pulmonary hypertension
2. RHC, 6MWT, echocardiography, NT-pro BNP, CMR performed in one month period.
3. Patients who signed study informed consent form.

Exclusion Criteria

1. Coronary and valvular heart disease
2. Atrial fibrillation
3. Expressed shortness of breath
4. Claustrophobia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right ventricle mechanical changes in pulmonary hypertension patients during follow up	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
Left ventricle function and mechanical changes in pulmonary hypertension patients during follow up	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 function and morphological changes in pulmonary hypertension patients during follow up	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

Trial Locations

Locations (1)

LSMU; 🇱🇹 Kaunas, Lithuania