EUCTR2016-001199-31-NL
Active, Not Recruiting
Phase 1
Improving treatment of right ventricular failure in pulmonary hypertension patients. - Improving treatment of RHF in PH patients.
Not provided0 sitesFebruary 2, 2017
ConditionsEnd stage right ventricular failure in pulmonary hypertension patientsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
DrugsTerlipressin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- End stage right ventricular failure in pulmonary hypertension patients
- Sponsor
- Not provided
- Status
- Active, Not Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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