ChanGes In Right ventricular volumes And Function Following diurEtic Treatment In Pulmonary arterial hypertension patients with decompensated right heart failure (GIRAFFE)

Completed

Conditions: pulmonary hypertension
right heart failure
10082206
10037454

Registration Number: NL-OMON44204

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

- Diagnosis of idiopathic PAH, hereditary PAH, drug- and toxins induced PAH or chronic thrombo-embolic PH (CTEPH), according to ESC/ERS pulmonary hypertension guidelines (15)
- Symptoms of decompensated right heart failure (ankle edema, ascites, weight gain) based on the assessment and the evaluation of the pulmonologist for which an up-titration of the diuretics is indicated
- Age >=18 and <=80 years
- Able to understand and willing to sign the Informed Consent Form

Exclusion Criteria

- Pregnant subjects
- Claustrophobia
- Inability to provide informed consent
- Change in PAH specific therapy during or the 3 months before the up-titration of diuretics
- Change in (dose) of any other medication.
- One or more of the following co-morbidities:, uncontrolled systemic hypertension (>140/90 mmHg) , renal failure (eGFR <30), recent diagnosis of pulmonary embolism (within 6 months).
- Contraindication for CMR imaging:
o Claustrophobia
o Implanted cardiac defibrillator or pacemaker
o Cochlear implant
o Others
- PH of any cause other than permitted in the entry criteria
- Known history of noncompliance considering therapies

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in stroke volume (SV) , Change in right ventricular ejection fraction<br /><br>(RVEF) (%), Change in right ventricular end diastolic volume (RVEDV) (ml),<br /><br>Change in right ventricular end systolic volume (RVESV) (ml), Change in right<br /><br>atrial pressure (RAP),volume, Change in right ventricular strain.</p><br>

Secondary Outcome Measures