Back to resultsPilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension
Primary Purpose
Pulmonary Arterial Hypertension
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Sulfasalazine
Ambrisentan
Sulfasalazine's placebo
Ambrisentan's placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- Pulmonary artery systolic pressure estimated in the most recent echocardiography examination before screening ≧40mmHg.
- Before the study, subjects received the best traditional pulmonary arterial hypertension(PAH) treatment (such as oral Ca2+ antagonists, oxygen therapy, digoxin, diuretics, and anticoagulants), and no increase, discontinuation, or dose change at least one month before randomization. But it is allowed to stop or adjust anticoagulants, and adjust the therapeutic dose of diuretics.
- The results of echocardiography showed that the systolic and diastolic functions of the left ventricle were normal, and there was no clinically significant left heart disease (such as mitral valve disease).
Exclusion Criteria:
- Patients who have received endothelin receptor antagonists and anti-inflammatory drugs within 30 days before randomization.
- Patients with changes in the basic PAH treatment within one month before randomization (such as addition/removal of therapeutic drugs or dose adjustment; including but not limited to oxygen, diuretics, digoxin, anticoagulants, immunosuppressants, or Ca2+ antagonists ). But we allows the discontinuation of anticoagulants or change the dose and the change of diuretic dose.
- Patients who diagnosed with other etiology of PAH, such as portal hypertension, pulmonary vein occlusive disease, etc.
- Patients who have a history of left heart disease including ischemic heart disease, myocardial infarction, symptomatic coronary artery disease; or trans-channel radionuclide angiography, angiography, or echocardiography as assessed by mean pulmonary capillary wedge pressure (or left ventricular end diastolic volume) ≥ 15 mmHg or left ventricular ejection fraction ≤ 40%; or systemic hypertension that cannot be effectively controlled, systolic blood pressure> 160 mmHg or diastolic blood pressure> 100 mmHg.
- Patients who have a history of lung diseases, including chronic obstructive pulmonary disease, interstitial lung disease, etc.
- Patients who have a history of blood diseases, including a history of coagulation disorders within 6 months before screening.
- Patients who are allergic to two or more drugs or food; or are known to be allergic to one anti-inflammatory drug (steroidal or non-steroidal anti-inflammatory drug).
- Liver function test exceeds or equals 3 times the upper limit of normal or suffering from known Child-Pugh Class C liver disease.
- Patients with chronic renal insufficiency, and the screening creatinine value is greater than 2.5mg/dL (221μmol/L) or need dialysis.
- Patients with other diseases or conditions that can affect the results of the research.
- Patients who participated in other study drugs or medical devices within 30 days before screening.
Sites / Locations
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Placebo Comparator
Arm Label
Ambrisentan+Sulfasalazine
Ambrisentan+Sulfasalazine's placebo
Ambrisentan's placebo+Sulfasalazine
Ambrisentan's placebo+Sulfasalazine's placebo
Arm Description
Outcomes
Primary Outcome Measures
Time to First Confirmed Clinical Adverse Event up to the End of Treatment
Clinical adverse event was defined as death.
Secondary Outcome Measures
Change From Baseline to Month 6 in 6-minute Walk Distance
The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.
Change From Baseline to Month 6 in Inflammation Factor
Compose of Interleukin-6
Change From Baseline to Month 6 in Echocardiography Examination
Assessment of pulmonary artery systolic pressure by echocardiography
Change From Baseline to Month 6 in Cardiac Function
Compose of B-type natriuretic peptide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04528056
Brief Title
Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension
Official Title
Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.
Detailed Description
Pulmonary arterial hypertension is characterized by decompensated increase of pulmonary artery pressure owing to continuous progression of pulmonary vascular resistance and can ultimately cause right heart failure even death. At present, the treatment of pulmonary arterial hypertension is mainly the application of specific drug therapy. Specific drug therapy involves the three major pathways of endothelin, nitric oxide and prostacyclin. The main mechanisms of vasodilation and anti-proliferation are used to treat pulmonary arterial hypertension. However, the price of specific drug therapy is too expensive, which puts huge financial pressure on patients. Evidence shows that inflammation exists in the early stages of pulmonary arterial hypertension and anti-inflammatory treatment is effective in animal experiments. Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ambrisentan+Sulfasalazine
Arm Type
Experimental
Arm Title
Ambrisentan+Sulfasalazine's placebo
Arm Type
Active Comparator
Arm Title
Ambrisentan's placebo+Sulfasalazine
Arm Type
Experimental
Arm Title
Ambrisentan's placebo+Sulfasalazine's placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sulfasalazine
Intervention Description
Sulfasalazine is an anti-inflammatory and immunosuppressive drug
Intervention Type
Drug
Intervention Name(s)
Ambrisentan
Intervention Description
Ambrisentan is one of the specific drug therapy for pulmonary arterial hypertension
Intervention Type
Drug
Intervention Name(s)
Sulfasalazine's placebo
Intervention Description
Sulfasalazine's placebo is similar to Sulfasalazine in form and dosage
Intervention Type
Drug
Intervention Name(s)
Ambrisentan's placebo
Intervention Description
Ambrisentan's placebo is similar to Ambrisentan in form and dosage
Primary Outcome Measure Information:
Title
Time to First Confirmed Clinical Adverse Event up to the End of Treatment
Description
Clinical adverse event was defined as death.
Time Frame
Up to end of treatment (data presented up to month 6)
Secondary Outcome Measure Information:
Title
Change From Baseline to Month 6 in 6-minute Walk Distance
Description
The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.
Time Frame
Baseline to month 6
Title
Change From Baseline to Month 6 in Inflammation Factor
Description
Compose of Interleukin-6
Time Frame
Baseline to month 6
Title
Change From Baseline to Month 6 in Echocardiography Examination
Description
Assessment of pulmonary artery systolic pressure by echocardiography
Time Frame
Baseline to month 6
Title
Change From Baseline to Month 6 in Cardiac Function
Description
Compose of B-type natriuretic peptide
Time Frame
Baseline to month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pulmonary artery systolic pressure estimated in the most recent echocardiography examination before screening ≧40mmHg.
Before the study, subjects received the best traditional pulmonary arterial hypertension(PAH) treatment (such as oral Ca2+ antagonists, oxygen therapy, digoxin, diuretics, and anticoagulants), and no increase, discontinuation, or dose change at least one month before randomization. But it is allowed to stop or adjust anticoagulants, and adjust the therapeutic dose of diuretics.
The results of echocardiography showed that the systolic and diastolic functions of the left ventricle were normal, and there was no clinically significant left heart disease (such as mitral valve disease).
Exclusion Criteria:
Patients who have received endothelin receptor antagonists and anti-inflammatory drugs within 30 days before randomization.
Patients with changes in the basic PAH treatment within one month before randomization (such as addition/removal of therapeutic drugs or dose adjustment; including but not limited to oxygen, diuretics, digoxin, anticoagulants, immunosuppressants, or Ca2+ antagonists ). But we allows the discontinuation of anticoagulants or change the dose and the change of diuretic dose.
Patients who diagnosed with other etiology of PAH, such as portal hypertension, pulmonary vein occlusive disease, etc.
Patients who have a history of left heart disease including ischemic heart disease, myocardial infarction, symptomatic coronary artery disease; or trans-channel radionuclide angiography, angiography, or echocardiography as assessed by mean pulmonary capillary wedge pressure (or left ventricular end diastolic volume) ≥ 15 mmHg or left ventricular ejection fraction ≤ 40%; or systemic hypertension that cannot be effectively controlled, systolic blood pressure> 160 mmHg or diastolic blood pressure> 100 mmHg.
Patients who have a history of lung diseases, including chronic obstructive pulmonary disease, interstitial lung disease, etc.
Patients who have a history of blood diseases, including a history of coagulation disorders within 6 months before screening.
Patients who are allergic to two or more drugs or food; or are known to be allergic to one anti-inflammatory drug (steroidal or non-steroidal anti-inflammatory drug).
Liver function test exceeds or equals 3 times the upper limit of normal or suffering from known Child-Pugh Class C liver disease.
Patients with chronic renal insufficiency, and the screening creatinine value is greater than 2.5mg/dL (221μmol/L) or need dialysis.
Patients with other diseases or conditions that can affect the results of the research.
Patients who participated in other study drugs or medical devices within 30 days before screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jieyan Shen, PhD
Phone
+8613701864819
Email
shenjieyan@renji.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieyan Shen, PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Wang, postgraduate
Phone
+8613780172992
Email
wangjian_ky@163.com
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension
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