To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis (BosSilSS)
Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis
調査の概要
詳細な説明
All patients fulfilling the SSc classification criteria of American College of Rheumatology during the study period will be screened for presence of PAH. Diagnosed cases of PAH based on CD echo with PAP >35mmHg based on echocardiography will be enrolled in study.Baseline NYHA functional class and 6 min walk distance in meters will be assessed. Heamogram and LFT will be measured Patients will be assessed at two weeks for side effects/safety issues. 6MWT and NYHA functional class will be reassessed at 3 months and 6 months.2D echo will be done at 6 months to measure mPAP RandomizationAll eligible patients will be randomized in a 1:1 ratio in blocks of ten between the two arms. Randomization will be stratified based on severity of PAH. The drugs will be labelled as A and B randomly by another staff member, who will not be involved in deciding the treatment of the study subjects. The randomization sequence will be generated using computer random number generator.
Blinding will be ensured by matching placebo for ERA in one group and will labelled one treatment arm as 'A' and other treatment arm as 'B'. Allocation concealment will be ensured by means of enclosing the randomization sequence in sealed opaque envelopes. Sealed opaque envelopes will contain Code 'A' or Code 'B'.
Intervention-The study consists of two treatment arms. The study drugs mainly Bosentan and Placebo will be packed into matching tablets at the dosage 62.5 mg. One treatment arm will contain Sildenafil and Placebo while other treatment arm will contain Sildenafil and Bosentan. Treatment will be initiated as 20 mg twice a day for Sildena-fil in combination with placebo once a day in one treatment arm and with Bosentan 62.5 mg once a day in other treatment arm .Dose of Sildenafil will be increased to 20 mg thrice a day at four weeks and that of Bosentan to 62.5 mg twice a day. Placebo will be also be provided twice a day.This will be continued till end of study period.. Dose adjustments in case of adverse events will be made depending on the severity of adverse events.
Statistical analysis- Intention to treat analysis will be carried for the primary and secondary outcomes. For continuous outcomes, unpaired t-test and for dichotomous outcomes chi-squares test with Yate's correction will be used. P<0.05 will be considered significant
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Chandigarh、インド、160012
- 募集
- Dr Preksha Dwivedi
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コンタクト：
- Preksha Dwivedi, MD
- 電話番号：+91-8109492343
- メール：drpreksha07@gmail.com
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コンタクト：
- Shefali Sharma, MD
- 電話番号：+91-9417372439
- メール：Sharmashefali@hotmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female patients aged 18 years
- Patients with systemic sclerosis
- PAH diagnosed as PAP>35mmHg
- NYHA functional class II,III,IV
- SSc disease duration >1years
Exclusion Criteria:
- Forced vital capacity <60% predicted
- Renal insufficiency
- Left heart disease and other relevant cardiac conditions
- Pregnant or breastfeeding female
- Patients on PAH specific therapy
- Liver disease
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Combination arm A-Sildenafil and Bosentan
Combination Arm A -Intervention- Drug
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Sildenafil 20 mg three times a day and bosentan 62.5mg two times a day
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プラセボコンパレーター：Monotherapy arm-Sildenafil and Placebo
Monotherapy arm B Intervention-Drugs Tab Sildenafil 20mg- three times a day for 6 months, and Placebo tab (matched for bosentan) for 6 months
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Sildenafil 20 mg three times a day and placebo (matched for bosentan)two times a day
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Pulmonary artery pressures
時間枠：Baseline and 6 months
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Change in Pulmonary artery pressures measured by echocardiography at baseline and 6 months in patients of systemic sclerosis with PAH when treatment with Single(PDE-5inhibitors at dose of 20 mg maximum upto 60mg) versus Dual therapy(PDE-5inhibitors and ER antagonist 62.5 mg maximum upto 125mg) for 6 months
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Baseline and 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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1.Change in 6 Minute walk distance
時間枠：Baseline and 6 months
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1. To compare change in 6 MWD at baseline, and 6 months when treated with single versus dual therapy.
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Baseline and 6 months
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Time To Clinical Worsening (TTCW)
時間枠：Baseline and 6 months
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To compare time to clinical worsening (TTCW) in SSc patients when treated with single versus dual therapy.
TTCW is defined as first occurrence of all cause deaths, PAH related hospitalisation, worsening of symptoms defined as a decrease of >15% in 6 min walk distance and worsening of NYHA functional class.
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Baseline and 6 months
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Emergent side effects of Sildenafil and Bosentan
時間枠：Baseline to 6 months
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To compare the emergent side effects of sildenafil and bosentan by way of comparison of serious and nonserious side effects.
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Baseline to 6 months
|
協力者と研究者
捜査官
- スタディチェア：Nandita Kakker, M.D、Institutional ethics committee,PGIMER Chandigarh,India
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MK/2927/DM/9430
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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