To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

Brief Summary

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The study will be carried out on 50 consecutive consenting patients of systemic sclerosis with PAH recruited from outpatient department of internal medicine and rheumatology clinic of PGIMER, Chandigarh, India It is a single centre double blind randomised controlled trial evaluating the effect of upfront dual therapy (sildenafil and bosentan) vs monotherapy (sildenafil) Participants will be randomised in 1:1 ratio to one of treatment arms. Placebo and PDE-5 inhibitors 20 mg BD to 60 mg if patient tolerates the drug well to one study arm and PDE-5 inhibitors plus ER antagonist 62.5 to max of 125 to other study group

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Detailed Description

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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

Conditions

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Associated Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Combination arm A-Sildenafil and Bosentan

Combination Arm A -Intervention- Drug

* Tab Sildenafil 20 mg - three times a day for 6 months,and
* Tab Bosentan 62.5mg - twice a day for 6 months

Group Type ACTIVE_COMPARATOR

Sildenafil 20mg and Bosentan 62.5mg

Intervention Type DRUG

Sildenafil 20 mg three times a day and bosentan 62.5mg two times a day

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

Group Type PLACEBO_COMPARATOR

Sildenafil 20mg and Placebo

Intervention Type DRUG

Sildenafil 20 mg three times a day and placebo (matched for bosentan)two times a day

Interventions

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Sildenafil 20mg and Bosentan 62.5mg

Sildenafil 20 mg three times a day and bosentan 62.5mg two times a day

Intervention Type DRUG

Sildenafil 20mg and Placebo

Sildenafil 20 mg three times a day and placebo (matched for bosentan)two times a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No