Sodium tanshinone IIA sulfonate (STS) is a water-soluble derivative of tanshinone IIA isolated as the main pharmacologically active natural compound from a traditional Chinese herbal medicine,the dried root of Salvia miltiorrhiza Bunge known as Danshen. Danshen has been known for the function of improving body functions such as activating blood circulation and removing blood stasis according to the theory of traditional Chinese medicine. Danshen and its various formula products including STS have been long-time widely used in oriental countries, especially China to treat various inflammatory and cardiovascular diseases for its pharmacological actions, including vasodilatation, anticoagulation, anti-inflammation, and free radical scavenging,with negligible adverse effects observed. The investigator's objective is to evaluate whether STS exhibits beneficial effects on pulmonary hypertension. This is a randomized, controlled, multicentre clinical trial study. 90 patients with pulmonary hypertension will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection will also be permitted if necessary) 250ml iv drip once a day for 8 weeks,as well as 20mg sildenafil citrate tablets by mouth three times a day for the same duration of treatment
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGmPAP by right heart catheterization
To assess if sodium Tanshinone IIA sulfonate decreases mean pulmonary arterial pressure.
Time frame: At the end of 0- and 8-week trial
WHO functional class of pulmonary hypertension(PH)
Time frame: At the end of 0-,2-, 4-,6- and 8-week of trial
Borg dyspnea score
Time frame: At the end of 0-, 2-,4-,6- and 8-week trial
Minnesota living with heart failure questionnaire
Time frame: At the end of 0-,2-, 4-,6- and 8-week trial
6-minute walk distance (6MWD)
To assess if sodium Tanshinone IIA sulfonate improves the exercise capacity of patients with pulmonary hypertension.
Time frame: At the end of 0-, 2-, 4-, 6- and 8-week trial
Pulmonary vascular resistance(PVR) measured by right heart catheterization
PVR is used to evaluate whether STS decreases mPAP or increases pulmonary circulatory blood flow.
Time frame: At the end of 0- and 8-week trial
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