Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension (STS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Collaborators:
Jiangsu Carefree Pharmaceutical Co., LTD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Guangdong General Hospital, Guangzhou, China
Sir run run shaw hospital Zhejiang University School of Medicine, Hangzhou, China
The First Affiliated Hospital of Zhengzhou University
Dongguan People's Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
Beijing Chao Yang Hospital
Beijing Anzhen Hospital
Qingdao University
Information provided by (Responsible Party):
Nanshan Zhong, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01637675
First received: July 1, 2012
Last updated: March 28, 2014
Last verified: March 2014

July 1, 2012
March 28, 2014
May 2013
December 2014   (final data collection date for primary outcome measure)
mPAP by right heart catheterization [ Time Frame: At the end of 0- and 8-week trial ] [ Designated as safety issue: No ]
To assess if sodium Tanshinone IIA sulfonate decreases mean pulmonary arterial pressure.
Pulmonary arterial systolic pressure [ Time Frame: At 8 weeks of trial ] [ Designated as safety issue: No ]
To assess if Tanshinone IIA sodium sulfonate alleviates pulmonary arterial systolic pressure.
Complete list of historical versions of study NCT01637675 on ClinicalTrials.gov Archive Site
  • WHO functional class of pulmonary hypertension(PH) [ Time Frame: At the end of 0-,2-, 4-,6- and 8-week of trial ] [ Designated as safety issue: No ]
  • Borg dyspnea score [ Time Frame: At the end of 0-, 2-,4-,6- and 8-week trial ] [ Designated as safety issue: No ]
  • Minnesota living with heart failure questionnaire [ Time Frame: At the end of 0-,2-, 4-,6- and 8-week trial ] [ Designated as safety issue: No ]
  • 6-minute walk distance (6MWD) [ Time Frame: At the end of 0-, 2-, 4-, 6- and 8-week trial ] [ Designated as safety issue: No ]
    To assess if sodium Tanshinone IIA sulfonate improves the exercise capacity of patients with pulmonary hypertension.
  • Pulmonary vascular resistance(PVR) measured by right heart catheterization [ Time Frame: At the end of 0- and 8-week trial ] [ Designated as safety issue: No ]
    PVR is used to evaluate whether STS decreases mPAP or increases pulmonary circulatory blood flow.
  • Pulmonary function [ Time Frame: At 0, 4, and 8 weeks of trial ] [ Designated as safety issue: No ]
    FEV1
  • Exercise capacity [ Time Frame: At 0, 4 and 8 weeks of trial ] [ Designated as safety issue: No ]
    6-minute walking distance
  • Quality of life [ Time Frame: At 0, 4 and 8 weeks of trial ] [ Designated as safety issue: No ]
    Minnesota heart failure quality of life score
  • Symptom score [ Time Frame: At 0, 4 and 8 weeks of trial ] [ Designated as safety issue: No ]
    Borg dyspnoea scale
  • Clinical chemistry parameters [ Time Frame: At 0, 4 and 8 weeks of trial ] [ Designated as safety issue: No ]
    BNP, D-dimers
  • Kidney, heart and liver function [ Time Frame: At 0, 4 and 8 weeks of trial ] [ Designated as safety issue: Yes ]
    BUN,Cr, AST, ALT
  • The level of N terminal-proBNP(NT-proBNP),cardiac troponin I(cTnI) and uric acid(UA) in serum [ Time Frame: At the end of 0-,4- and 8-week trial ] [ Designated as safety issue: No ]
    The three indicators are used to evaluate whether STS alleviates right heart failure.
  • Indicators monitoring STS safety [ Time Frame: At the end of 0-,4- and 8-week trial ] [ Designated as safety issue: Yes ]
    The blood routine test,urine routine test,liver and kidney function and blood clotting function will be examined and some worsening events,such as death,PH aggravation,need to add other unscheduled target drugs,need to be hospitalized or prolonged hospitalization,lung and/or heart transplantation and/or any other severe adverse events surely or very likely due to STS,will be closely observed as the safety indications of STS.
  • Other hemodynamic parameters measured by right heart catheterization [ Time Frame: At the end of 0- and 8-week trial ] [ Designated as safety issue: No ]
    To evaluate whether STS has beneficial effects on hemodynamic parameters.
Not Provided
 
Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension
Clinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Pulmonary Arterial Hypertension
  • Cardiovascular Diseases
  • Lung Diseases
  • Tanshinone IIA Sulfonate
  • Drug: 20 mg sildenafil citrate by mouth
    20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
    Other Name: Viagra
  • Drug: sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth
    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
    Other Names:
    • Sodium tanshinone IIA sulfonate injection
    • Viagra
  • Active Comparator: 20 mg sildenafil citrate tablets by mouth
    20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
    Intervention: Drug: 20 mg sildenafil citrate by mouth
  • Experimental: sodium tanshinone IIA sulfonate, sildenafil citrate tablets
    sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection also permitted if necessary) 250ml ivdrip once a day for 8 weeks,20mg sildenafil citrate tablets by mouth three times a day for the same duration
    Intervention: Drug: sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Meet the condition of mean pulmonary arterial pressure (mPAP) ≥25 mmHg at seal level at rest and pulmonary capillary wedge pressure(PCWP)≤15mmHg;
  2. Category 1 or 4 of PH in stable stage according to 2008 Dana Point Conference,including the idiopathic, hereditary, drugs and toxins induced, associated with connective tissue disease or congenital heart disease, and chronic thromboembolic pulmonary arterial hypertension(PAH) ;
  3. Male or female between 15 to 70 years old;
  4. WHO pulmonary hypertension functional class II or III;
  5. The baseline 6-minute walk distance between 150-550 m;
  6. Patients' condition should be stable for more than one month after basic treatment; For those patients with congenital heart disease, surgery should have been performed six months or more before they are enrolled in the study;
  7. Patients receiving sildenafil treatment only previously, or those without target drugs treatment during the past 3 months;
  8. Patients or their guardians should agree with this clinical trail and medical informed consent of the trial should be signed.

Exclusion Criteria:

  1. Unavailable or limited legal capacity;
  2. Pregnant or lactational women;
  3. Important organs with severe diseases;
  4. Mental or physical disability;
  5. With suspected or indeed alcohol, drug abuse history;
  6. With allergic constitution, with two or more drugs or foods allergy history or those who are allergic to any components of the experimental drugs;
  7. With both aspartate aminotransferase (AST) and glutamic-pyruvic transaminase (ALT) more than three times of the upper limit of normal in liver function test and Ccr≤50ml/min in kidney function test;
  8. Those with systemic blood pressure<90/50 mmHg, or those uncontrolled dangerous hypertension(BP>170/110 mmHg);
  9. Patients at active stages of infectious or other diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, and some connective tissue diseases;
  10. Patients with severe infection, especially pulmonary infection;
  11. Patients with shock or astable hemodynamics with other causes;
  12. Patients with hepatic cirrhosis, and hepatic cirrhosis induced portal hypertension;
  13. Patients with severe hemorrhage, and hemorrhagic tendency;
  14. Patients who need to take or be taking drugs possible or indeed affecting this trial;
  15. Patients cannot accomplish required items (especially 6MWD) because of acute/chronic organic disease (excluding dyspnea) or other illnesses such as lower extremity diseases;
  16. Patients with any other conditions considered cannot be recruited.
Both
15 Years to 70 Years
No
Contact: Jian Wang, MD +8615013388183 jwang31@jhmi.edu
China
 
NCT01637675
STS-PH01
Yes
Nanshan Zhong, The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
  • Jiangsu Carefree Pharmaceutical Co., LTD
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Guangdong General Hospital, Guangzhou, China
  • Sir run run shaw hospital Zhejiang University School of Medicine, Hangzhou, China
  • The First Affiliated Hospital of Zhengzhou University
  • Dongguan People's Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Beijing Chao Yang Hospital
  • Beijing Anzhen Hospital
  • Qingdao University
Not Provided
The First Affiliated Hospital of Guangzhou Medical University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP