The pressure overloaded right ventricle: a deformation imaging study

The pressure overloaded right ventricle: a deformation imaging study - RV-DEF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38071

Enrollment

270

Registered

2011-04-01

Start date

2011-08-04

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aangeboren hartafwijking pressure overloaded right heart chamber pulmonale hypertensie

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years or older PAH group 1, inoperable CTEPH or simple ccTGA, TGA after Mustard or Senning, RVOTO/PS, Tetralogy of Fallot Healthy control subject ;All 18 years or over

Exclusion criteria

Exclusion criteria: Clinically unstable/deteroriating For healthy controls: abnormalities in physical examination, ECG or echocardiography, top athlete legally incapable/unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame
Study parameters: - For the first objective o Echocardiographic characteristics of RV deformation and RV volumetrics in the patients with pressure overloaded right ventricles, measuring strain and strain rate. o Deformation pattern of the RV in these patients characterized by MR tagging, including torsion and twist of left and right ventricle. Volumetric data derived from MR imaging. o Functional parameters obtained by cardiopulmonary exercise testing; VO2 max, anaerobic threshold, Ve/VCO2 and non-invasive cardiac output measurements; stroke volume and dP/dt. o Delayed enhancement MRI to quantify fibrosis; spectroscopy of the septum. o Pulmonary perfusion data obtained by MR scanning. - For the second objective (only PH patients): o Standard 2D&3D echocardiographic parameters and speckle tracking in 2D and 3D. o Cardiopulmonary exercise testing including the measurements mentioned above. - For the third objective: o RV strain values derived by 3D speckle tracking and MR tagging (to establish validity of 3D with MR tagging as a reference). - For the fourth objective: o Strain values for circumferential, longitudinal and radial strain (and if possible torsion of the RV) of healthy volunteers. o Volumetric data of the RV obtained with Ventripoint. End points (for prognostic part of study in PH patients): - Total time to clinical worsening, defined as: all cause mortality, nonelective hospital stay for PH and disease progression defined as a reduction from baseline in the 6MWT by 15% (confirmed by 2 studies done within 2 weeks) plus worsening in functional class.	—

Measure

Time frame

Study parameters: - For the first objective o Echocardiographic characteristics of RV deformation and RV volumetrics in the patients with pressure overloaded right ventricles, measuring strain and strain rate. o Deformation pattern of the RV in these patients characterized by MR tagging, including torsion and twist of left and right ventricle. Volumetric data derived from MR imaging. o Functional parameters obtained by cardiopulmonary exercise testing; VO2 max, anaerobic threshold, Ve/VCO2 and non-invasive cardiac output measurements; stroke volume and dP/dt. o Delayed enhancement MRI to quantify fibrosis; spectroscopy of the septum. o Pulmonary perfusion data obtained by MR scanning. - For the second objective (only PH patients): o Standard 2D&3D echocardiographic parameters and speckle tracking in 2D and 3D. o Cardiopulmonary exercise testing including the measurements mentioned above. - For the third objective: o RV strain values derived by 3D speckle tracking and MR tagging (to establish validity of 3D with MR tagging as a reference). - For the fourth objective: o Strain values for circumferential, longitudinal and radial strain (and if possible torsion of the RV) of healthy volunteers. o Volumetric data of the RV obtained with Ventripoint. End points (for prognostic part of study in PH patients): - Total time to clinical worsening, defined as: all cause mortality, nonelective hospital stay for PH and disease progression defined as a reduction from baseline in the 6MWT by 15% (confirmed by 2 studies done within 2 weeks) plus worsening in functional class.

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Secondary

Measure	Time frame
Secondary endpoints: - Mortality - Onset to right ventricular failure (clinical diagnosis)	—

Countries

Netherlands

Outcome results