UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001350 |
|---|---|
| Receipt number | R000001589 |
| Scientific Title | Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2018/03/12 22:16:51 |
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Basic information
Public title
Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases
Acronym
Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study)
Scientific Title
Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases
Scientific Title:Acronym
Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study)
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension (PAH) associated with connective tissue disease
Classification by specialty
| Cardiology | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Connective tissue diseases (CTD) are categorized as systemic inflammatory disorders characterized by autoimmune phenomena. Pulmonary arterial hypertension (PAH) is one of life-threatening manifestations of CTD, whose histological features are thickening of pulmonary artery walls. The treatment is often difficult, and its outcome is very poor because of progressive right ventricular failure and low cardiac output. Recently, novel drugs, including prostacyclin analogs, endothelin receptor antagonists, and phosphodiesterase-5 inhibitors, have been developed and are available for treatment for idiopathic PAH and PAH associated with CTD. Rationales for these treatments are mainly based on results of clinical trials enrolling patients with severe PAH classified as having WHO functional class III or IV. Despite these novel options, PAH is still one of leading causes of death in patients with CTD, including systemic sclerosis and mixed connective tissue disease. Thus, significance of early intervention for these patients is now on dispute. However, there is no evidence for the efficacy of early intervention to PAH in modifying a natural course of PAH-CTD. In this study, Sildenafil is selected as a candidate drug for early intervention to PAH-CTD. As a control drug we use Beraprost, which is commonly used for the treatment of peripheral vascular disease associated with CTD in Japan. Also we analyze the effect of PAH drugs for peripheral vascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to clinical worsening
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Beraprost sodium
Interventions/Control_2
Beraprost sodium and Sildenafil citrate
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who are followed up at institutions in which this clinical trial is exected.
2)Patients who fulfill the classification criteria of collagen diseases such as SLE, SSc, PM/DM, and MCTD.
3)Mean pulmonary arterial pressure is over 20 mmHg and PCWP is less than 15 measured by right heart catheterization. 4) Patients classified as WHO functional class I or II
Key exclusion criteria
1) Hypersensitivity to Sildenafil or Beraprost.
2) Patients with chronic pulmonary thromboembolism.
3) Patients who will be on home oxygen therapy
4) Patients who will be classified as WHO class III or IV
5) Patients with severe ischemic heart diseases or cardiomyopathy
6) Patients with malignancy
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Kuwana |
Organization
Department of Internal Medicine, Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
03-3353-1211
kuwanam@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekata Yasuoka |
Organization
Department of Internal Medicine, Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
yasuokah@z8.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
KEEP-ACTIVE study group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
亀田総合病院（千葉県）、川崎市立井田病院（神奈川県）、川崎市立川崎病院（神奈川県）、慶應義塾大学病院（東京都）、国立病院機構東京医療センター（東京都）、埼玉医科大学総合医療センター（埼玉県）、聖路加国際病院（東京都）、東京歯科大学市川総合病院（東京都）、東京女子医科大学病院（東京都）、東京都立大塚病院（東京都）、聖マリアンナ医科大学（神奈川県）、北里大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 02 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001589
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