Right Ventricular Haemodynamic Evaluation and Response to Treatment (Rightheart I)

University of Giessen

Status: Unknown

Conditions: Right Ventricular Dysfunction

Treatments: Diagnostic Test: conductance catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03403868

108/15

Details and patient eligibility

About

Mono-center Study to evaluate different multimodal functional parameter of the right ventricle in PAH-patients

Full description

Mono-center-study tu evaluate functional parameters in cardiac MRI, conductance catheter (pressure-volume-loops), echocardiography and right heart catheter in PAH patients and to compare different multimodal parameters

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PH Nizza group 1 and patients without pulmonary hypertension after having the right heart catheter on clinical grounds

• ability to sign informed consent

• male and female between 18 to 85 years

• haemodynamic criteria:

  • Pulmonary vascular resistance (PVR) > 240 dyn x sec x cm-5
  • Mean Pulmonary artery pressure (mPAP) ≥ 25 mmHg for PAH patients

• normal haemodynamic in controls

• therapy-naive or at least since two months stabil therapy with approved drugs for PAH (Sildenafil, Tadalafil, Macitentan, Ambrisentan, Bosentan, Iloprost, Treprostinil, Riociguat).

Exclusion criteria

• therapy with positive inotropic drugs (dobutamin etc.)
• missing informed consent
• pregnancy or lactation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Conductance catheter

Other group

Description:

Contractility-measurement with conductance catheter (pressure-volume-catheter)

Treatment:

Diagnostic Test: conductance catheter