Back to results

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

Primary Purpose

Pulmonary Hypertension, Pulmonary Arterial Hypertension, Cardiovascular Diseases

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

20 mg sildenafil citrate by mouth

sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring sodium tanshinone IIA sulfonate, pulmonary hypertension

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the condition of mean pulmonary arterial pressure (mPAP) ≥25 mmHg at seal level at rest and pulmonary capillary wedge pressure(PCWP)≤15mmHg;
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) ;
Male or female between 15 to 70 years old;
WHO pulmonary hypertension functional class II or III;
The baseline 6-minute walk distance between 150-550 m;
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;
Patients receiving sildenafil treatment only previously, or those without target drugs treatment during the past 3 months;
Patients or their guardians should agree with this clinical trail and medical informed consent of the trial should be signed.

Exclusion Criteria:

Unavailable or limited legal capacity;
Pregnant or lactational women;
Important organs with severe diseases;
Mental or physical disability;
With suspected or indeed alcohol, drug abuse history;
With allergic constitution, with two or more drugs or foods allergy history or those who are allergic to any components of the experimental drugs;
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;
Those with systemic blood pressure<90/50 mmHg, or those uncontrolled dangerous hypertension(BP>170/110 mmHg);
Patients at active stages of infectious or other diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, and some connective tissue diseases;
Patients with severe infection, especially pulmonary infection;
Patients with shock or astable hemodynamics with other causes;
Patients with hepatic cirrhosis, and hepatic cirrhosis induced portal hypertension;
Patients with severe hemorrhage, and hemorrhagic tendency;
Patients who need to take or be taking drugs possible or indeed affecting this trial;
Patients cannot accomplish required items (especially 6MWD) because of acute/chronic organic disease (excluding dyspnea) or other illnesses such as lower extremity diseases;
Patients with any other conditions considered cannot be recruited.

Sites / Locations

The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

20 mg sildenafil citrate tablets by mouth

sodium tanshinone IIA sulfonate, sildenafil citrate tablets

Arm Description

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 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

Outcomes

Primary Outcome Measures

mPAP by right heart catheterization

To assess if sodium Tanshinone IIA sulfonate decreases mean pulmonary arterial pressure.

Secondary Outcome Measures

WHO functional class of pulmonary hypertension(PH)

Borg dyspnea score

Minnesota living with heart failure questionnaire

6-minute walk distance (6MWD)

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

PVR is used to evaluate whether STS decreases mPAP or increases pulmonary circulatory blood flow.

Full Information

NCT ID

NCT01637675

First Posted

July 1, 2012

Last Updated

March 28, 2014

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Collaborators

Jiangsu Carefree Pharmaceutical Co., Ltd., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Guangdong Provincial People's Hospital, Sir Run Run Shaw Hospital, 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, The Affiliated Hospital of Qingdao University

1. Study Identification

Unique Protocol Identification Number

NCT01637675

Brief Title

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

Acronym

STS

Official Title

Clinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension, Pulmonary Arterial Hypertension, Cardiovascular Diseases, Lung Diseases, Tanshinone IIA Sulfonate

Keywords

sodium tanshinone IIA sulfonate, pulmonary hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

20 mg sildenafil citrate tablets by mouth

Arm Type

Active Comparator

Arm Description

20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks

Arm Title

sodium tanshinone IIA sulfonate, sildenafil citrate tablets

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

20 mg sildenafil citrate by mouth

Other Intervention Name(s)

Viagra

Intervention Description

20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks

Intervention Type

Drug

Intervention Name(s)

sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth

Other Intervention Name(s)

Sodium tanshinone IIA sulfonate injection, Viagra

Intervention Description

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

Primary Outcome Measure Information:

Title

mPAP by right heart catheterization

Description

To assess if sodium Tanshinone IIA sulfonate decreases mean pulmonary arterial pressure.

Time Frame

At the end of 0- and 8-week trial

Secondary Outcome Measure Information:

Title

WHO functional class of pulmonary hypertension(PH)

Time Frame

At the end of 0-,2-, 4-,6- and 8-week of trial

Title

Borg dyspnea score

Time Frame

At the end of 0-, 2-,4-,6- and 8-week trial

Title

Minnesota living with heart failure questionnaire

Time Frame

At the end of 0-,2-, 4-,6- and 8-week trial

Title

6-minute walk distance (6MWD)

Description

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

Title

Pulmonary vascular resistance(PVR) measured by right heart catheterization

Description

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

Other Pre-specified Outcome Measures:

Title

The level of N terminal-proBNP(NT-proBNP),cardiac troponin I(cTnI) and uric acid(UA) in serum

Description

The three indicators are used to evaluate whether STS alleviates right heart failure.

Time Frame

At the end of 0-,4- and 8-week trial

Title

Indicators monitoring STS safety

Description

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.

Time Frame

At the end of 0-,4- and 8-week trial

Title

Other hemodynamic parameters measured by right heart catheterization

Description

To evaluate whether STS has beneficial effects on hemodynamic parameters.

Time Frame

At the end of 0- and 8-week trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the condition of mean pulmonary arterial pressure (mPAP) ≥25 mmHg at seal level at rest and pulmonary capillary wedge pressure(PCWP)≤15mmHg; 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) ; Male or female between 15 to 70 years old; WHO pulmonary hypertension functional class II or III; The baseline 6-minute walk distance between 150-550 m; 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; Patients receiving sildenafil treatment only previously, or those without target drugs treatment during the past 3 months; Patients or their guardians should agree with this clinical trail and medical informed consent of the trial should be signed. Exclusion Criteria: Unavailable or limited legal capacity; Pregnant or lactational women; Important organs with severe diseases; Mental or physical disability; With suspected or indeed alcohol, drug abuse history; With allergic constitution, with two or more drugs or foods allergy history or those who are allergic to any components of the experimental drugs; 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; Those with systemic blood pressure<90/50 mmHg, or those uncontrolled dangerous hypertension(BP>170/110 mmHg); Patients at active stages of infectious or other diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, and some connective tissue diseases; Patients with severe infection, especially pulmonary infection; Patients with shock or astable hemodynamics with other causes; Patients with hepatic cirrhosis, and hepatic cirrhosis induced portal hypertension; Patients with severe hemorrhage, and hemorrhagic tendency; Patients who need to take or be taking drugs possible or indeed affecting this trial; Patients cannot accomplish required items (especially 6MWD) because of acute/chronic organic disease (excluding dyspnea) or other illnesses such as lower extremity diseases; Patients with any other conditions considered cannot be recruited.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Wang, MD

Phone

+8615013388183

jwang31@jhmi.edu

Facility Information:

Facility Name

The First Affiliated Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Wang, MD

Phone

+8615013388183

jwang31@jhmi.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs