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
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Chandigarh, 인도, 160012
- 모병
- Dr Preksha Dwivedi
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연락하다:
- Preksha Dwivedi, MD
- 전화번호: +91-8109492343
- 이메일: drpreksha07@gmail.com
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연락하다:
- Shefali Sharma, MD
- 전화번호: +91-9417372439
- 이메일: Sharmashefali@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Pulmonary artery pressures
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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1.Change in 6 Minute walk distance
기간: 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)
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 연구 의자: Nandita Kakker, M.D, Institutional ethics committee,PGIMER Chandigarh,India
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MK/2927/DM/9430
약물 및 장치 정보, 연구 문서
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