Associated Pulmonary Arterial Hypertension Clinical Trial
Official title:
Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis
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
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
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03069716 -
A Mobile Health Intervention in Pulmonary Arterial Hypertension
|
N/A |