End stage right ventricular failure in pulmonary hypertension patients
Conditions
Interventions
Trade Name: Terlipressin
Pharmaceutical Form: Solution for injection/infusion
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion 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; o Mean Pulmonary Artery Pressure (mPAP) = 25 mmHg o Pulmonary Arterial Wedge Pressure (PCWP) 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore efficacy and safety of terlipressin as add on therapy to loop diuretics in patients with pre-capillary pulmonary hypertension who are hospitalized for right ventricular failure.;Secondary Objective: Not applicable;Primary end point(s): The aim of this study is: “To explore efficacy and safety of terlipressin as add on therapy to loop diuretics in patients with pre-capillary pulmonary hypertension who are hospitalized for right ventricular failure.” Change in creatinine after 48 hours, is considered as a primary safety endpoint. Endpoint assessment will be after 48 hours and when, in opinion of the clinician an optimal volume status of the patient is reached. Primary efficacy endpoint will be weight loss over the first 48 hours after start of drug administration. This study is considered positive when: The weight loss after 48h is higher in the terlipressin treated patients and change in creatinine is smaller or not significantly increased compared to patients who are treated with loop diuretics alone. ;Timepoint(s) of evaluation of this end point: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other study parameters and endpoints are: • Fluid balance (= Fluid intake – urine output) after 48h • Urine output after 48h • Final dose of loop diuretics at 48h • Time interval from treatment start to accomplishing an optimal volume status/ time to dismissal • Change in creatinine at t = 48h, t = 72h and at dismissal • N-terminal brain-type natriuretic peptide (NT-proBNP) levels • Total weight loss at dismissal • Total urine output at dismissal • Need for additional treatment (in both treatment arms) ;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Netherlands
Outcome results
None listed