Back to resultsEfficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH) (CTREPH)
Primary Purpose
Non-operable Chronic Thromboembolic Pulmonary Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Treprostinil sodium
Sponsored by
About this trial
This is an interventional treatment trial for Non-operable Chronic Thromboembolic Pulmonary Hypertension
Eligibility Criteria
- Subject must be competent to understand the information given in the written informed consent and from the investigator and must sign and date the informed consent prior to any study mandated procedure.
- Subject must be at least 18 years of age and can be of any ethnical origin
- Women of child bearing potential must be surgically sterile or postmenopausal (amenorrhea for at least 12 months) or using an acceptable form of contraception. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used correctly such as, implants, injectables, oral contraceptive medications, sexual abstinence, or a vasectomised partner.
Subject must have a current diagnosis of CTEPH, as defined by the following criteria:
- A test result of perfusion scintigraphy and pulmonary angiography and/or multislice CT not older than 6 months, consistent with the diagnosis CTEPH. In case of recurrent PH after PEA, test results from before the surgery are acceptable if a typical specimen was harvested during PEA substantiating the diagnosis of CTEPH.
- A right heart catheterization, not older than 6 months, consistent with the diagnosis CTEPH but specifically with a mean pulmonary artery pressure (PAPm) of > 25 mmHg, and a PVR of > 300 dyn.s.cm-5
- At least three months of effective anticoagulation therapy (without improvement / to exclude subacute pulmonary emboli)
Subject must have CTEPH classified as severe, as defined by the following criteria:
- An un-encouraged 6MWT distance of between 150 and 400 meters
- Classification in the WHO/New York Heart Association (NYHA) functional class III or IV
The subject must not be suitable to undergo a PEA and is therefore defined as non-operable, due to at least one of the following reasons:
- Clot is not accessible
- Discrepancy between severity of PH and morphologic lesion
- Subject is not a good surgical candidate for other reasons:
PVR > 1500 dynes.s.cm-5 Age Comorbidity No functional lung parenchyma
- Unsuccessful PEA in the past with residual/recurrent CTEPH
- No consent for PEA given by subject
- Subject must be willing and able to follow all study procedures
Exclusion:
- Subject with any form of pulmonary arterial hypertension or any disease known to cause PAH (WHO Group I)
- Subjects with a total lung capacity (TLC) of < 70% predicted or a forced expiratory volume/forced vital capacity (FEV1/FVC < 50%)
- Subject who received any prostanoids, within the 30 days before screening or be scheduled to receive prostanoids during the course of the study
- Subject with a new type of chronic therapy (a different category of vasodilator or diuretic) for PAH added within the last month, except anticoagulants
- Subject with an increased risk for hemorrhage or stroke or with a major cardiovascular event during the past 6 months.
- Unstable subjects for any reason (according to the investigators discretion)
- Subject who received any investigational medication within 30 days prior to the screening visit of this study or be scheduled to receive another investigational drug during the course of this study
- Subject with a known intolerance to any drug relevant for this trial, especially to Treprostinil sodium or prostanoids
- Subject with a history or suspicion of non compliance
- Subject who has any musculoskeletal disease or any other disease that would limit ambulation
- Subject with other cardiovascular, liver, renal, hematologic, gastrointestinal immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the investigator, may adversely affect the safety of the subject and /or efficacy of the study drug or limit the lifespan of the subject
- Female who is considering pregnancy or who is pregnant and/or lactating
- Subject who is an investigator or any other team member involved directly or indirectly in the conduct of the clinical study.
- Subject who is an inmate of a psychiatric ward, prison or is suspected not to be able to give consent of his free will
Sites / Locations
- Krankenhaus der Elisabethinen
- Medical University of Vienna AKH - Division Cardiology
- II. interní klinika Všeobecná fakultní nemocnice
- Medical University Carl Gustav Carus Medizinische Klinik und Poliklinik I Medizinische Fakultät der Technischen Universität Dresden
- Department of Cardiac and Vascular Diseases Centre for Rare Cardiovascular Diseases John Paul II Hospital
- NZOZ Europejskie Centrum Zdrowia Otwock
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treprostinil sodium low dose - Arm I
Treprostinil sodium high dose - Arm II
Arm Description
Arm I (low dose): Subject was treated with a low dose of Treprostinil sodium. Dose was escalated to an approximate target dose of 3 ng/kg/min after the first 12 weeks and was kept stable for another 12 weeks. Due to the predefined infusion rate setting schedule an interim dose of up to 6 ng/kg/min could be reached for few days at the end of the phases 1,2 and 3. This depended on the patient's exact weight and is caused by the limited infusion rate setting possibility of the infusion pump.
Subject was treated with a low dose of Treprostinil sodium. Dose was escalated to an approximate target dose of 3 ng/kg/min after the first 12 weeks and kept stable for another 12 weeks. Due to the predefined infusion rate setting schedule an interim dose of up to 6 ng/kg/min could be reached for few days at the end of the phases 1,2 and 3. This depended on the patient's exact weight and is caused by the limited infusion rate setting possibility of the infusion pump.
Outcomes
Primary Outcome Measures
Change in 6-minute Walk Test Distance After 24 Weeks
To determine the effect of subcutaneous Treprostinil sodium on 6-minute walk test distance after 24 weeks in patients with severe non-operable chronic thromboembolic pulmonary hypertension severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
Time frame of the 6-minute walk test: The 6-minute walk test was conducted at the following visits:
baseline (day 1)
Visit 6 (day 168)
In case of missing values, Last-Observation-Carried-Forward imputation method was used. In such cases values documented at Visit 4 (day84) were used.
Secondary Outcome Measures
Number of Participants With Clinical Worsening
Clinical worsening defined as a decrease of 6-minute walk test distance of more than 20% from baseline due to Chronic Thromboembolic Pulmonary Hypertension, decrease of New York Heart Association functional class, hospitalization with the requirement for additional Pulmonary Hypertension specific treatment and/or death due to worsening Chronic Thromboembolic Pulmonary Hypertension.
Clinical Worsening was assessed after 12 weeks and 24 weeks, participants experiencing clinical worsening at any time-point are reported.
Effect on Maximal Borg Score During 6-minutes Walk Test
The Borg scale was used for rating of dyspnea during 6-minutes walk test. The scale is defined from 0 to > 10 (upper bound) (0 = NOTHING AT ALL; 0.5 = VERY VERY SLIGHT (just noticeable); 1 = VERY SLIGHT; 2 = SLIGHT; 3 = MODERATE; 4 = SOMEWHAT SEVERE; 5 = SEVERE; 6-9 = VERY SEVERE; 10 = VERY VERY SEVERE (almost maximum); >10 MAXIMUM).
As can be seen with the scale, the higher scale values represent a worse outcome.
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 48 patients in low dose group.
Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class
Class I - Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope.
Class II - Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III - Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope
Class IV - Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
Effect on Quality of Life by the MINNESOTA Questionnaire
This questionnaire is composed of 21 questions relating to limitations in lifestyle associated with Heart Failure. Respondents use a 5-point scale that ranges from 0 (none) to 5 (too much), with a score of 0 representing no limitation and a score of 5 representing maximum limitation. The change in individual score sum was evaluated and is displayed in the results, with a possible range of 0-105. Higher values indicate more limitations in Quality of Life.
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 50 patients randomized to high dose group and 46 patients in low dose group.
Effect on N-terminal Pro-BNP Levels
baseline values, assessment after 12 and 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 46 patients randomized to high dose group and 46 patients in low dose group.
Effect on Hemodynamic Parameter (PVR - Pulmonary Vascular Resistance)
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Effect on Hemodynamic Parameter (CI - Cardiac Index)
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Effect on Hemodynamic Parameter (CO - Cardiac Output)
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Effect on Hemodynamic Parameter (mPAP - Mean Pulmonary Arterial Pressure)
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 47 patients randomized to high dose group and 47 patients in low dose group.
Effect on Hemodynamic Parameter (mRap - Mean Right Atrial Pressure)
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Effect on Signs & Symptoms of the CTEPH
baseline values, assessment after 24 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01416636
Brief Title
Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
Acronym
CTREPH
Official Title
A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
April 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciPharm SàRL
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to determine the effect on six-minute walking test (6MWT) distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.
Detailed Description
Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by non-resolving organized thromboembolic obstructing the pulmonary vascular bed. These thrombi are resistant to thrombolytic therapy and chronic plasmatic anticoagulation. An increase in pulmonary vascular resistance (PVR), right ventricular overload, and eventually right ventricular failure ensue.
The treatment of choice for CTEPH is pulmonary endarterectomy (PEA), providing a potential cure for the disease. However, about 50 % of patients are not candidates for surgery, mainly because of distal location of thromboemboli. Despite recent advances in the treatment of pulmonary arterial hypertension (PAH), medical treatments have not been recommended for inoperable CTEPH, because of the concept that a predominantly major vessel obstructive arteriopathy would not be suitable for vasodilators. Furthermore, a major drawback of i.v. prostacyclin therapy is the need for a permanent central venous access that increases the risk of infection (0.22-0.68 per patient per year), thrombosis and new major vessel thromboembolism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-operable Chronic Thromboembolic Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treprostinil sodium low dose - Arm I
Arm Type
Active Comparator
Arm Description
Arm I (low dose):
Subject was treated with a low dose of Treprostinil sodium. Dose was escalated to an approximate target dose of 3 ng/kg/min after the first 12 weeks and was kept stable for another 12 weeks.
Due to the predefined infusion rate setting schedule an interim dose of up to 6 ng/kg/min could be reached for few days at the end of the phases 1,2 and 3.
This depended on the patient's exact weight and is caused by the limited infusion rate setting possibility of the infusion pump.
Arm Title
Treprostinil sodium high dose - Arm II
Arm Type
Experimental
Arm Description
Subject was treated with a low dose of Treprostinil sodium. Dose was escalated to an approximate target dose of 3 ng/kg/min after the first 12 weeks and kept stable for another 12 weeks.
Due to the predefined infusion rate setting schedule an interim dose of up to 6 ng/kg/min could be reached for few days at the end of the phases 1,2 and 3.
This depended on the patient's exact weight and is caused by the limited infusion rate setting possibility of the infusion pump.
Intervention Type
Drug
Intervention Name(s)
Treprostinil sodium
Primary Outcome Measure Information:
Title
Change in 6-minute Walk Test Distance After 24 Weeks
Description
To determine the effect of subcutaneous Treprostinil sodium on 6-minute walk test distance after 24 weeks in patients with severe non-operable chronic thromboembolic pulmonary hypertension severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
Time frame of the 6-minute walk test: The 6-minute walk test was conducted at the following visits:
baseline (day 1)
Visit 6 (day 168)
In case of missing values, Last-Observation-Carried-Forward imputation method was used. In such cases values documented at Visit 4 (day84) were used.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Worsening
Description
Clinical worsening defined as a decrease of 6-minute walk test distance of more than 20% from baseline due to Chronic Thromboembolic Pulmonary Hypertension, decrease of New York Heart Association functional class, hospitalization with the requirement for additional Pulmonary Hypertension specific treatment and/or death due to worsening Chronic Thromboembolic Pulmonary Hypertension.
Clinical Worsening was assessed after 12 weeks and 24 weeks, participants experiencing clinical worsening at any time-point are reported.
Time Frame
12 weeks and 24 weeks
Title
Effect on Maximal Borg Score During 6-minutes Walk Test
Description
The Borg scale was used for rating of dyspnea during 6-minutes walk test. The scale is defined from 0 to > 10 (upper bound) (0 = NOTHING AT ALL; 0.5 = VERY VERY SLIGHT (just noticeable); 1 = VERY SLIGHT; 2 = SLIGHT; 3 = MODERATE; 4 = SOMEWHAT SEVERE; 5 = SEVERE; 6-9 = VERY SEVERE; 10 = VERY VERY SEVERE (almost maximum); >10 MAXIMUM).
As can be seen with the scale, the higher scale values represent a worse outcome.
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 48 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class
Description
Class I - Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope.
Class II - Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III - Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope
Class IV - Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
Time Frame
Baseline and 24 weeks
Title
Effect on Quality of Life by the MINNESOTA Questionnaire
Description
This questionnaire is composed of 21 questions relating to limitations in lifestyle associated with Heart Failure. Respondents use a 5-point scale that ranges from 0 (none) to 5 (too much), with a score of 0 representing no limitation and a score of 5 representing maximum limitation. The change in individual score sum was evaluated and is displayed in the results, with a possible range of 0-105. Higher values indicate more limitations in Quality of Life.
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 50 patients randomized to high dose group and 46 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Effect on N-terminal Pro-BNP Levels
Description
baseline values, assessment after 12 and 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 46 patients randomized to high dose group and 46 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Effect on Hemodynamic Parameter (PVR - Pulmonary Vascular Resistance)
Description
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Effect on Hemodynamic Parameter (CI - Cardiac Index)
Description
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Effect on Hemodynamic Parameter (CO - Cardiac Output)
Description
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Effect on Hemodynamic Parameter (mPAP - Mean Pulmonary Arterial Pressure)
Description
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 47 patients randomized to high dose group and 47 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Effect on Hemodynamic Parameter (mRap - Mean Right Atrial Pressure)
Description
baseline values, assessment after 24 weeks
As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group.
Time Frame
Baseline and 24 weeks
Title
Effect on Signs & Symptoms of the CTEPH
Description
baseline values, assessment after 24 weeks
Time Frame
Baseline and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject must be competent to understand the information given in the written informed consent and from the investigator and must sign and date the informed consent prior to any study mandated procedure.
Subject must be at least 18 years of age and can be of any ethnical origin
Women of child bearing potential must be surgically sterile or postmenopausal (amenorrhea for at least 12 months) or using an acceptable form of contraception. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used correctly such as, implants, injectables, oral contraceptive medications, sexual abstinence, or a vasectomised partner.
Subject must have a current diagnosis of CTEPH, as defined by the following criteria:
A test result of perfusion scintigraphy and pulmonary angiography and/or multislice CT not older than 6 months, consistent with the diagnosis CTEPH. In case of recurrent PH after PEA, test results from before the surgery are acceptable if a typical specimen was harvested during PEA substantiating the diagnosis of CTEPH.
A right heart catheterization, not older than 6 months, consistent with the diagnosis CTEPH but specifically with a mean pulmonary artery pressure (PAPm) of > 25 mmHg, and a PVR of > 300 dyn.s.cm-5
At least three months of effective anticoagulation therapy (without improvement / to exclude subacute pulmonary emboli)
Subject must have CTEPH classified as severe, as defined by the following criteria:
An un-encouraged 6MWT distance of between 150 and 400 meters
Classification in the WHO/New York Heart Association (NYHA) functional class III or IV
The subject must not be suitable to undergo a PEA and is therefore defined as non-operable, due to at least one of the following reasons:
Clot is not accessible
Discrepancy between severity of PH and morphologic lesion
Subject is not a good surgical candidate for other reasons:
PVR > 1500 dynes.s.cm-5 Age Comorbidity No functional lung parenchyma
Unsuccessful PEA in the past with residual/recurrent CTEPH
No consent for PEA given by subject
Subject must be willing and able to follow all study procedures
Exclusion:
Subject with any form of pulmonary arterial hypertension or any disease known to cause PAH (WHO Group I)
Subjects with a total lung capacity (TLC) of < 70% predicted or a forced expiratory volume/forced vital capacity (FEV1/FVC < 50%)
Subject who received any prostanoids, within the 30 days before screening or be scheduled to receive prostanoids during the course of the study
Subject with a new type of chronic therapy (a different category of vasodilator or diuretic) for PAH added within the last month, except anticoagulants
Subject with an increased risk for hemorrhage or stroke or with a major cardiovascular event during the past 6 months.
Unstable subjects for any reason (according to the investigators discretion)
Subject who received any investigational medication within 30 days prior to the screening visit of this study or be scheduled to receive another investigational drug during the course of this study
Subject with a known intolerance to any drug relevant for this trial, especially to Treprostinil sodium or prostanoids
Subject with a history or suspicion of non compliance
Subject who has any musculoskeletal disease or any other disease that would limit ambulation
Subject with other cardiovascular, liver, renal, hematologic, gastrointestinal immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the investigator, may adversely affect the safety of the subject and /or efficacy of the study drug or limit the lifespan of the subject
Female who is considering pregnancy or who is pregnant and/or lactating
Subject who is an investigator or any other team member involved directly or indirectly in the conduct of the clinical study.
Subject who is an inmate of a psychiatric ward, prison or is suspected not to be able to give consent of his free will
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Lang, MD
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus der Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medical University of Vienna AKH - Division Cardiology
City
Vienna
Country
Austria
Facility Name
II. interní klinika Všeobecná fakultní nemocnice
City
Prague
Country
Czechia
Facility Name
Medical University Carl Gustav Carus Medizinische Klinik und Poliklinik I Medizinische Fakultät der Technischen Universität Dresden
City
Dresden
Country
Germany
Facility Name
Department of Cardiac and Vascular Diseases Centre for Rare Cardiovascular Diseases John Paul II Hospital
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
NZOZ Europejskie Centrum Zdrowia Otwock
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
8205686
Citation
Lang IM, Marsh JJ, Olman MA, Moser KM, Loskutoff DJ, Schleef RR. Expression of type 1 plasminogen activator inhibitor in chronic pulmonary thromboemboli. Circulation. 1994 Jun;89(6):2715-21. doi: 10.1161/01.cir.89.6.2715.
Results Reference
background
PubMed Identifier
15194182
Citation
Klepetko W, Mayer E, Sandoval J, Trulock EP, Vachiery JL, Dartevelle P, Pepke-Zaba J, Jamieson SW, Lang I, Corris P. Interventional and surgical modalities of treatment for pulmonary arterial hypertension. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):73S-80S. doi: 10.1016/j.jacc.2004.02.039.
Results Reference
background
PubMed Identifier
15249497
Citation
McLaughlin VV, Presberg KW, Doyle RL, Abman SH, McCrory DC, Fortin T, Ahearn G; American College of Chest Physicians. Prognosis of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004 Jul;126(1 Suppl):78S-92S. doi: 10.1378/chest.126.1_suppl.78S.
Results Reference
background
PubMed Identifier
12446266
Citation
Kuhn KP, Byrne DW, Arbogast PG, Doyle TP, Loyd JE, Robbins IM. Outcome in 91 consecutive patients with pulmonary arterial hypertension receiving epoprostenol. Am J Respir Crit Care Med. 2003 Feb 15;167(4):580-6. doi: 10.1164/rccm.200204-333OC. Epub 2002 Nov 21.
Results Reference
background
PubMed Identifier
30477763
Citation
Sadushi-Kolici R, Jansa P, Kopec G, Torbicki A, Skoro-Sajer N, Campean IA, Halank M, Simkova I, Karlocai K, Steringer-Mascherbauer R, Samarzija M, Salobir B, Klepetko W, Lindner J, Lang IM. Subcutaneous treprostinil for the treatment of severe non-operable chronic thromboembolic pulmonary hypertension (CTREPH): a double-blind, phase 3, randomised controlled trial. Lancet Respir Med. 2019 Mar;7(3):239-248. doi: 10.1016/S2213-2600(18)30367-9. Epub 2018 Nov 23.
Results Reference
derived
Learn more about this trial
Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
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