Assessing the Safety and Bioactivity of SG1002 in Heart Failure Patients
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
sodium polysulthionate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- symptomatic heart failure, with New York Heart Association (NYHA) classification of stage III;
- be ambulatory;
- have left ventricular ejection fraction less than 40% within 6 months of screening;
- have heart failure that has been stable for the previous 3 months (defined by no change in baseline therapy or symptoms of heart failure for the previous 3 months)(changes in diuretics are permitted);
- if female, be either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from signing of the informed consent form though to the Final Visit/Early Termination Visit; and
- be willing and able to provide written informed consent.
Exclusion Criteria:
- pregnant or breastfeeding;
- has had any of the following within 3 months prior to screening: myocardial infarction, unstable angina, cerebrovascular accident, percutaneous coronary intervention, open heart surgery, cardiac resynchronisation therapy (CRT) or transient ischaemic attack (TIA);
- has serious cerebrovascular disease in the opinion of the PI;
- is unable to walk without the assistance of another person;
- has primary lung disease that is the major contributor to current symptom status;
- is currently participating in another interventional clinical study, or has participated in one within 30 days prior to screening;
- has an inability to speak English (due to need to administer standardised English-language questionnaires);
- has current symptomatic hypotension (defined as systolic blood pressure (SBP) ≤ 90 mmHg or diastolic blood pressure (DBP) ≤ 40 mmHg);
- has poorly controlled hypertension (defined as SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) despite therapy;
- will have percutaneous coronary intervention or open heart surgery within 3 months of the screening visit;
- has serious liver disease;
- has poorly controlled diabetes (defined as HbA1c > 10.0 %);
- has hypersensitivity to sulfur or related compounds;
- uses sulfur containing products or supplements, such as dimethyl sulfoxide (DMSO) or methylsulfonylmethane (MSM);
- has renal insufficiency defined as eGFR < 30 mL/minute/1.73 m2 (Modification of Diet in Renal Disease Study MDRD);
- has a life expectancy of less than 6 months;
- has active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the Investigator, interfere with study treatment or participation. (Stable basal cell skin cancer and cancers being treated solely with hormonal therapy are allowed);
- has evidence of drug or alcohol abuse within the past 3 years;
- has any other chronic illness that may, in the opinion of the Investigator, increase the risks associated with this trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
0 mg SG1002
1600 mg SG1002
Arm Description
Capsules containing 400 mg of placebo will be provided to subjects. Subjects will take two tablets twice each day.
Capsules containing 400 mg of sodium polysulthionate (SG1002) will be provided to subjects. Subjects will take two tablets twice each day, providing subjects with 1600 mg SG1002 daily.
Outcomes
Primary Outcome Measures
Composite measure using adverse events, clinical laboratory tests, vital signs and ECGs
Changes in blood levels of hydrogen sulfide and nitrite in the SG1002 group measured by comparing the area under the curves after administration of the first dose and baseline levels of each at the first visit versus the final visit.
Demonstration of bioactivity as evidenced by increases in circulating levels of hydrogen sulfide and/or one or more nitric oxide metabolites, including nitrite, S-nitrosothiols and guanosine cyclic monophosphate levels as assessed by comparing AUC between placebo and SG1002 groups and by comparing baseline levels pre-administration at the start of the study to preadministration at the conclusion of the study.
Secondary Outcome Measures
Heart function
A change from baseline to 13 weeks in BNP levels or cardiac remodeling as assessed by echocardiograms
Body mass and waste circumference
A change from baseline to 13 weeks in waist circumference and body mass index
Biomarkers of inflammation and oxidative stress
A change from baseline to 13 weeks in biomarkers of inflammation, C-reactive Protein (CRP) and interleukin 6 (IL6) and oxidative stress, oxidized LDL (oxLDL) and ratio of reduced glytathione (GSH) to oxidized glutathione (GSSG)
Walking distance in 6 minute
A change from baseline to 13 weeks in the distance walked in 6 minutes
Minnesota Heart Failure Questionnaire
A change from baseline to 13 weeks in quality of life as assessed by Minnesota Heart Failure Questionnaire
Full Information
NCT ID
NCT02278276
First Posted
October 23, 2014
Last Updated
November 25, 2015
Sponsor
Sulfagenix Australia Pty Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02278276
Brief Title
Assessing the Safety and Bioactivity of SG1002 in Heart Failure Patients
Official Title
A Randomised, Double-blinded, Placebo-controlled Study to Assess the Safety and Bioactivity of Sodium Polysulthionate (SG1002) in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sulfagenix Australia Pty Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and benefits of SG1002, including overcoming deficits in circulating hydrogen sulfide and nitrite found in heart failure patients, with secondary endpoints focused on improving clinical endpoints.
Detailed Description
This will be a 3 month, placebo controlled double blind study, to determine whether 800 mg SG1002 given twice daily will be safe and will improve circulating levels of hydrogen sulfide and/or nitrite in heart failure subjects. In addition, secondary endpoints such as 6 minute walk distance, Minnesota heart failure questionnaire, biomarkers of inflammation and oxidative stress and cardiac remodeling will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0 mg SG1002
Arm Type
Placebo Comparator
Arm Description
Capsules containing 400 mg of placebo will be provided to subjects. Subjects will take two tablets twice each day.
Arm Title
1600 mg SG1002
Arm Type
Active Comparator
Arm Description
Capsules containing 400 mg of sodium polysulthionate (SG1002) will be provided to subjects. Subjects will take two tablets twice each day, providing subjects with 1600 mg SG1002 daily.
Intervention Type
Drug
Intervention Name(s)
sodium polysulthionate
Intervention Description
Bioavailable composition of α-sulfur
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
400 mg capsules containing placebo
Primary Outcome Measure Information:
Title
Composite measure using adverse events, clinical laboratory tests, vital signs and ECGs
Time Frame
3 month
Title
Changes in blood levels of hydrogen sulfide and nitrite in the SG1002 group measured by comparing the area under the curves after administration of the first dose and baseline levels of each at the first visit versus the final visit.
Description
Demonstration of bioactivity as evidenced by increases in circulating levels of hydrogen sulfide and/or one or more nitric oxide metabolites, including nitrite, S-nitrosothiols and guanosine cyclic monophosphate levels as assessed by comparing AUC between placebo and SG1002 groups and by comparing baseline levels pre-administration at the start of the study to preadministration at the conclusion of the study.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Heart function
Description
A change from baseline to 13 weeks in BNP levels or cardiac remodeling as assessed by echocardiograms
Time Frame
3 months
Title
Body mass and waste circumference
Description
A change from baseline to 13 weeks in waist circumference and body mass index
Time Frame
3 months
Title
Biomarkers of inflammation and oxidative stress
Description
A change from baseline to 13 weeks in biomarkers of inflammation, C-reactive Protein (CRP) and interleukin 6 (IL6) and oxidative stress, oxidized LDL (oxLDL) and ratio of reduced glytathione (GSH) to oxidized glutathione (GSSG)
Time Frame
3 months
Title
Walking distance in 6 minute
Description
A change from baseline to 13 weeks in the distance walked in 6 minutes
Time Frame
3 months
Title
Minnesota Heart Failure Questionnaire
Description
A change from baseline to 13 weeks in quality of life as assessed by Minnesota Heart Failure Questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic heart failure, with New York Heart Association (NYHA) classification of stage III;
be ambulatory;
have left ventricular ejection fraction less than 40% within 6 months of screening;
have heart failure that has been stable for the previous 3 months (defined by no change in baseline therapy or symptoms of heart failure for the previous 3 months)(changes in diuretics are permitted);
if female, be either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from signing of the informed consent form though to the Final Visit/Early Termination Visit; and
be willing and able to provide written informed consent.
Exclusion Criteria:
pregnant or breastfeeding;
has had any of the following within 3 months prior to screening: myocardial infarction, unstable angina, cerebrovascular accident, percutaneous coronary intervention, open heart surgery, cardiac resynchronisation therapy (CRT) or transient ischaemic attack (TIA);
has serious cerebrovascular disease in the opinion of the PI;
is unable to walk without the assistance of another person;
has primary lung disease that is the major contributor to current symptom status;
is currently participating in another interventional clinical study, or has participated in one within 30 days prior to screening;
has an inability to speak English (due to need to administer standardised English-language questionnaires);
has current symptomatic hypotension (defined as systolic blood pressure (SBP) ≤ 90 mmHg or diastolic blood pressure (DBP) ≤ 40 mmHg);
has poorly controlled hypertension (defined as SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) despite therapy;
will have percutaneous coronary intervention or open heart surgery within 3 months of the screening visit;
has serious liver disease;
has poorly controlled diabetes (defined as HbA1c > 10.0 %);
has hypersensitivity to sulfur or related compounds;
uses sulfur containing products or supplements, such as dimethyl sulfoxide (DMSO) or methylsulfonylmethane (MSM);
has renal insufficiency defined as eGFR < 30 mL/minute/1.73 m2 (Modification of Diet in Renal Disease Study MDRD);
has a life expectancy of less than 6 months;
has active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the Investigator, interfere with study treatment or participation. (Stable basal cell skin cancer and cancers being treated solely with hormonal therapy are allowed);
has evidence of drug or alcohol abuse within the past 3 years;
has any other chronic illness that may, in the opinion of the Investigator, increase the risks associated with this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Giordano, PhD
Phone
318-349-3851
Email
tgiordano@sulfagenix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Giordano, PhD
Organizational Affiliation
Sulfagenix Australia Pty Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Assessing the Safety and Bioactivity of SG1002 in Heart Failure Patients
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