Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension (TRUST-1)
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ClinicalTrials.gov Identifier: NCT00494533
(Safety issues related to outpatient intravenous infusion in India)
Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV) infection or collagen vascular disease).
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
Six-minute walk distance [ Time Frame: Twelve Weeks ]
Placebo-corrected change in 6-minute walk distance from Baseline to Week 12.
Secondary Outcome Measures
Borg Dyspnea Score [ Time Frame: Twelve Weeks ]
The Bord dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).
Dyspnea-Fatigue Index [ Time Frame: Twelve weeks ]
The dyspnea-fatigue index was assessed at Baseline, Weeks 1, 4, 8 ans 12. Each of the three components of the dyspnea-fatigue index were rated on a scale of 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.
NYHA Functional Class [ Time Frame: Twelve Weeks ]
Changes from Baseline in NYHA Functional Class will be summarized and compared between treatment groups at Weeks 1, 4, 8 and 12.
Clinical Worsening [ Time Frame: Twelve Weeks ]
Clinical worsening was defined as worsening PAH resulting in death, transplant, hospitalization, necessity to unblind for rescue therapy, or an inability to physically perform the walk assessment. Incidence of clinical worsening and the time from Baseline to clinical worsening will be compared between treatment groups.
Combined Walk and Borg Dyspnea Score [ Time Frame: 12 Weeks ]
The intent of the Six-Minute Walk Test is to determine how much patients can do during the course of carrying out activities of daily living. However, the capacity of patients to function is determined not only by what they can do when they exert themselves to the fullest, but also by how they feel when they are carrying out their usual activities of daily living. It is therefore important not only to look at the distance traversed during the unencouraged 6-minute walk but also the symptoms experienced at the end of the effort. To do so, walk distances and Borg Scores from the Week 12 Six-Minute Walk Test were simultaneously compared between treatment groups.
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Ages Eligible for Study:
16 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria: Patients Must
Between 16- 75 years of age.
Male or, if female, physiologically incapable of childbearing or utilizing birth control.
Have current diagnosis of symptom-limited NYHA Functional Class III/IV PAH that is:
PPH ("idiopathic" or familial PAH); or
PAH associated with collagen vascular disease (confirmed by antinuclear antibody titer or acceptable test); or
PAH associated with HIV infection (confirmed by serological test).
If HIV positive, have CD4 lymphocyte count ≥ 200 at baseline and receiving current SOC anti-retroviral or effective medication for HIV infection.
Optimally treated with conventional PH therapy and clinically stable for at least 1 month prior to baseline.
Have ventilation/perfusion scan, contrast-enhanced CT scan, or pulmonary angiogram after onset of PAH that rules out pulmonary embolism.
Have cardiac catheterization in last 3 months (or at Baseline) showing:
PAPm > 35 mmHg (at rest) &
PCWPm (or LV end diastolic pressure) < 16 mmHg &
PVR > 5 mmHg/L/min.
Have echocardiogram in last 3 months consistent with PH, specifically:
evidence of RV hypertrophy or dilation &
evidence of normal LV function &
absence of mitral valve stenosis.
Have chest radiograph consistent with PH performed in last 3 months. Radiograph must show clear lung fields or no more than patchy interstitial infiltrates.
Unless contraindicated, able to receive one of following anticoagulants: warfarin to achieve INR between 1.5-2.5 or heparin to produce aPTT between 1.3-1.5 times control, unless higher levels clinically indicated.
Mentally and physically capable of learning to administer Study Drug using ambulatory intravenous infusion pump and central venous access, or have trained caregiver.
If on corticosteroids, receiving stable dose of 20 mg/day of prednisone (or equivalent dose of another steroid) for at least 1 month prior to entry.
Exclusion Criteria: Patients must not:
Nursing or pregnant (women of childbearing potential have negative pregnancy test).
Have had new type of chronic therapy (including but not limited to oxygen, different category of vasodilator, diuretic, digoxin) for PH, except for anticoagulants, added in last month.
Be scheduled for heart-lung transplant.
Have any PH medication except for anticoagulants discontinued in week prior to study entry.
Have received any chronic prostaglandin or prostaglandin analogue (including intravenous/inhaled/oral: epoprostenol, iloprost, beraprost, etc.), any phosphodiesterase inhibitor therapy such as sildenafil, or any endothelin antagonist therapy such as bosentan, in past 30 days.
Have PH associated with chronic thromboembolic disease; or chronic obstructive lung diseases or hypoxemia; or evidence of significant parenchymal lung disease as evidenced by PFTs in last 3 months as follows (any one of following):
TLC < 60% (predicted) or high resolution CT documenting diffuse interstitial fibrosis or alveolitis
FEV1/FVC ratio < 50%
Have Portal Hypertension.
Have history of uncontrolled Sleep Apnea, defined as oxygen desaturation less than 90% at night, in past 3 months.
Have history of left-sided heart disease including:
Aortic or mitral valve disease or
Pericardial constriction or
Restrictive or congestive cardiomyopathy; or have evidence of current left-sided heart disease defined by:
PCWPm or LV end diastolic pressure > 16 mmHg or
LVEF < 40% by MUGA, angiography or echocardiography or
LV Shortening Fraction < 22% by echocardiography or