Improving treatment of right heart failure in patients with pulmonary hypertension.

Phase 1

Conditions: End stage right ventricular failure in pulmonary hypertension patients
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2016-001199-31-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Patients should be diagnosed with pre-capillary pulmonary hypertension either PAH or CTEPH, have clinical signs of decompensated right heart failure, and needing hospital - or ICU admission for IV diuretics.
• PAH (group 1 and 1’) or CTEPH (group 2), diagnosed according ESC/ERS guidelines;
oMean Pulmonary Artery Pressure (mPAP) = 25 mmHg
oPulmonary Arterial Wedge Pressure (PCWP) <15 mmHg
oOther possible causes of PH are excluded
• 18-70 years old
• Increased body weight despite increased dose diuretics in past month
• Clinical signs of decompensated right heart failure: ankle edema and/or ascites
• eGFR > 30 ml/min/1.73m2
• Sinus rhythm

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Pulmonary hypertension due to connective tissue disease, and PH due to left heart disease (group 2).
• Hypoxia defined as SaO2 =80% and/or = 90% with oxygen suppletion.
• Pregnancy, lactation
• Anuria (urine production <50 ml/day)
• Known intolerance of loop diuretics or terlipressin
• Recent diagnosis (<1 month ago) of acute pulmonary embolism
• Underlying infectious disorder/ bacteremia
• Known history of occlusive arterial disease (e.g. coronary artery disease) and/or peripheral artery disease, exception: pulmonary embolism
• Type 1 and type 2 diabetes mellitus
• Chronic use of NSAIDs
• Pre-existing renal failure from other causes than forward failure (eg diabetes)