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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01051960 |
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Date of registration:
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19/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
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Scientific title:
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Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot Study |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01051960 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Rajeev Saggar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Los Angeles |
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Name:
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Dinesh Khanna, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Los Angeles |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Systemic Sclerosis diagnosed by the American College of Rheumatology consensus
statement including any of the following:
- Limited
- Diffuse
- Sine Scleroderma
2. Patients must be willing and able to undergo right heart catheterization with lower
extremity cycle ergometry
3. Mean pulmonary artery pressure (mPAP) > 30mmHg with exercise; PCWP = 15mmHg on RHC at
rest
4. Men and women, ages 18 years of age or older
5. Standard adjunctive medications will be allowed concurrently in this study at the
discretion of the treating pulmonologist and rheumatologist, including digoxin,
diuretics, anticoagulants (e.g. warfarin), stable immunosuppression or other
anti-fibrotic therapy for at least one month prior to enrollment
Exclusion Criteria:
1. Resting PAH (mPAP > 25mmHg) on right heart catheterization
2. Other known causes of PAH including prior venous thromboembolism, HIV infection,
chronic liver disease with portal hypertension, left ventricular systolic dysfunction
(e.g. LVEF < 40%), and congenital causes of PAH
3. Severe hepatic disease precluding the use of ambrisentan (AST/ALT =3x ULN).
4. Women who are pregnant or breastfeeding.
5. Concurrent therapy with a prostanoid or prostanoid analogue, PDE5 inhibitors, or
enrolled in another active clinical study.
6. Use of any prostacyclin or endothelial receptor antagonist (ERA) within 30 days before
study entry.
7. Bed or wheel chair bound or a baseline 6-Minute Walk distance (6MWD) less than 150
meters.
8. Childbearing capable women who are unwilling or unable to use an acceptable method to
avoid pregnancy for the entire study period.
9. New York Heart Association (NYHA) Classification: Class IV
10. Renal dysfunction (serum creatinine >2.5mg/dL).
11. Uncontrolled sleep apnea.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Shortness of Breath
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Systemic Sclerosis
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Intervention(s)
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Drug: Ambrisentan
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Primary Outcome(s)
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Change in Exercise Pulmonary Hemodynamics From Baseline to Week 24
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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St. George's Respiratory Questionnaire
[Time Frame: 24 weeks]
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Quality of Life (QOL) Based on SF36 and HAQ-DI
[Time Frame: 24 weeks]
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HAQ-DI (Health Assessment Questionnaire Disability Index)
[Time Frame: 24 weeks]
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Change in Distance Walked in Six Minutes From Baseline to 24 Week
[Time Frame: 24 weeks]
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Secondary ID(s)
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10-000567
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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