EUCTR2016-001199-31-NLActive, not recruitingPhase 1
Improving treatment of right ventricular failure in pulmonary hypertension patients. - Improving treatment of RHF in PH patients.
Not provided0 sitesStarted: February 2, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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)
Investigators
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