Investigator-initiated trial of repeated administration of NK-104-NP in patients with pulmonary hypertensio
- Conditions
- Pulmonary arterial hypertensionD006976
- Registration Number
- JPRN-jRCT2031180075
- Lead Sponsor
- Egashira Kensuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 12
1) Patients with pulmonary hypertension classified as Dana Point group 1 and WHO functional class I to IV.
Idiopathic pulmonary arterial hypertension (IPAH)
Heritable pulmonary arterial hypertension (HPAH)
Drug or toxin-induced pulmonary hypertension
Pulmonary arterial hypertension associated with following diseases
a) Connective tissue diseases
b) Congenial heart diseases (at least 1 year has past after shunt repair at the baseline examinations)
c) HIV infection
2) Patients whose PAH is confirmed by right heart catheterization
Mean pulmonary arterial pressure (mPAP) at rest is over than or equal to 25 mmHg
Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure is under 15mmHg
3) Patients with over 240 dyn*sec/cm5 PVR at baseline right heart catherization
4) Patients treated with over 2 of 3 types of drugs (prostacyclin analogue, endothelin receptor antagonist, phosphodiesterase-5 inhibitor) and stable over 90 days
5) Over 20 and under 80 years old at the time of consent
Patients with a possibility of pregnancy must confirm their non-pregnant status before administration of NK-104-NP and agree to avoid pregnancy at least 180 days by secure contraception methods. Women with no possibility of pregnancy are defined as women who are post-menopausal state (no menses over 1 year, infertility or post-sterilization state).
6) Patients who have provided written informed consent with their signatures before procedures defined in the protocol.
1) Patients with malignancy or undergone surgeries due to malignancy within 5 years.
2) Patients taking statins and can NOT stop them from 3 days before administration of NK-104-NP.
3) Patients taking fibrates and can NOT stop them from 3 days before administration of NK-104-NP.
4) Patients taking cyclosporine.
5) Patients with severe cardiac dysfunction or heart failure (<30% ejection fraction or NYHA class III or over).
6) Patients with untreated severe arrhythmia except symptomatically stable patients with pacemaker or drug therapy.
7) Patients after prosthetic valve replacement (except biomaterials).
8) Patients with acute hepatitis, fulminant hepatitis or progressive liver dysfunction.
9) Patients with moderate or severe liver dysfunction (who can NOT satisfy following criteria) associated with chronic hepatitis etc. except patients with liver cirrhosis.
a) AST/ALT is within 3 times upper limit of shared reference range, b) serum bilirubin is 2 times upper limit of shared reference range.
10) Patients with liver cirrhosis and Child B(moderate) or C(severe) liver dysfunction.
11) Patients with obvious interstitial pneumonia.
12) Patients with biliary atresia.
13) Patients with CK(CPK) elevation over 3 times upper limit of shared reference range.
14) Patients with past-history of hypersensitivity or severe adverse effects by pitavastatin calcium.
15) Patients with severe drug allergy or adverse effects including anaphylactic shock.
16) Patients with alcohol abuse or drug addiction.
17) Patients in other trials at the time of informed consent or patients less than 16 weeks after termination of other test drugs.
18) Patients with pregnancy, patients with a possibility of pregnancy and breast-feeding women.
19) Patients judged to be inappropriate as a candidate of this trial by principal investigator or subinvestigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of pulmonary vascular resistance (PVR) between baseline and day 84
- Secondary Outcome Measures
Name Time Method Effectiveness: changes of following values between baseline and Day 84 <br>Mean right atrial pressure (mPAP) at rest <br>Mean pulmonary arterial pressure (mPAP) <br>Cardiac output (CO) <br>Cardiac index (CI) <br>Pulmonary vascular resistance index (PVRI) <br>Total pulmonary resistance (TPR) <br>Mixed venous oxygen saturation (SvO2) <br>Distance of 6 minutes walk <br>Modified Borg index <br>WHO functional class <br>NT-proBNP concentration <br>NOx concentration <br>Total pulmonary resistance index(TPRI) <br>Systemic vascular resistance index (SVRI) <br>Pulmonary vascular resistance (PVR) <br><br>Safety: Incidences of following events <br>Adverse effects <br>Severe adverse effects <br>Side effect