Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Cardiovascular Diseases
Lung Diseases
Tanshinone IIA Sulfonate
Drug: 20 mg sildenafil citrate by mouth
Drug: sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20 mg sildenafil citrate tablets by mouth
20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
Drug: 20 mg sildenafil citrate by mouth
20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
Other Name: Viagra
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
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

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637675

Contacts
Contact: Jian Wang, MD +8615013388183 jwang31@jhmi.edu

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jian Wang, MD    +8615013388183    jwang31@jhmi.edu   
Sponsors and Collaborators
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
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
  More Information

No publications provided

Responsible Party: Nanshan Zhong, Professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01637675     History of Changes
Other Study ID Numbers: STS-PH01
Study First Received: July 1, 2012
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
sodium tanshinone IIA sulfonate
pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Citric Acid
Pharmaceutical Solutions
Sildenafil
Tanshinone
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticoagulants
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Chelating Agents
Enzyme Inhibitors
Hematologic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on November 19, 2014