NL-OMON46099Not yet recruitingPhase 2
Improving treatment of right ventricular failure in pulmonary hypertension patients. - Improving treatment of RVF in PH patients.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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;
- •o Mean Pulmonary Artery Pressure (mPAP) >= 25 mmHg
- •o Pulmonary Arterial Wedge Pressure (PCWP) <15 mmHg
- •o Other possible causes of PH are excluded
- •18-70 years old
- •Increased body weight despite increased dose diuretics in past month
- •Clinical signs of decompensation: ankle edema and/or ascites
- •eGFR; 30 ml/min/1.73m2
- •Sinusrhythm
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)
Investigators
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