Heart FailurePhase 1/2NCT02278276
Assessing the Safety and Bioactivity of SG1002 in Heart Failure Patients
A Phase 1/2 study testing sodium polysulthionate in people with Heart Failure, run by Sulfagenix Australia Pty Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- sodium polysulthionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomised, Double-blinded, Placebo-controlled Study to Assess the Safety and Bioactivity of Sodium Polysulthionate (SG1002) in Heart Failure Patients
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- sodium polysulthionate, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium polysulthionateDrug
Bioavailable composition of α-sulfur
PlaceboDrug
400 mg capsules containing placebo
| Study group | Role | What they receive |
|---|---|---|
| 0 mg SG1002 | Placebo comparator | Capsules containing 400 mg of placebo will be provided to subjects. Subjects will take two tablets twice each day. Receives: Drug: Placebo |
| 1600 mg SG1002 | Active comparator | 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. Receives: Drug: sodium polysulthionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure using adverse events, clinical laboratory tests, vital signs and ECGs
Measured: 3 month
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.
Measured: 3 months
Secondary outcomes (5)
Heart function
A change from baseline to 13 weeks in BNP levels or cardiac remodeling as assessed by echocardiograms
Measured: 3 months
Body mass and waste circumference
A change from baseline to 13 weeks in waist circumference and body mass index
Measured: 3 months
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)
Measured: 3 months
Walking distance in 6 minute
A change from baseline to 13 weeks in the distance walked in 6 minutes
Measured: 3 months
Minnesota Heart Failure Questionnaire
A change from baseline to 13 weeks in quality of life as assessed by Minnesota Heart Failure Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sulfagenix Australia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Giordano, PhD, Study director, Sulfagenix Australia Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278276
- Sponsor's protocol ID
- Sulfagenix-SG1002-002
- Status last verified
- Nov 2015
- First submitted
- 23 Oct 2014
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Placebo-controlled Study to Assess the Safety and Bioactivity of Sodium Polysulthionate (SG1002) in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02278276
- Acronym / sponsor ID
- Sulfagenix-SG1002-002
- Conditions
- Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sulfagenix Australia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0 mg SG1002 | Placebo comparator | Drug: PlaceboCapsules containing 400 mg of placebo will be provided to subjects. Subjects will take two tablets twice each day. |
| 1600 mg SG1002 | Active comparator | Drug: sodium polysulthionateCapsules 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium polysulthionateBioavailable composition of α-sulfur | Drug | 1600 mg SG1002 |
| Placebo400 mg capsules containing placebo | Drug | 0 mg SG1002 |
Primary outcome
Composite measure using adverse events, clinical laboratory tests, vital signs and ECGs
Time frame: 3 month
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.
Time frame: 3 months
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.
5 secondary outcomes
Heart function
Time frame: 3 months
Body mass and waste circumference
Time frame: 3 months
Biomarkers of inflammation and oxidative stress
Time frame: 3 months
Walking distance in 6 minute
Time frame: 3 months
Minnesota Heart Failure Questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Giordano, PhD study director
Sulfagenix Australia Pty Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sodium polysulthionate in people with Heart Failure, run by Sulfagenix Australia Pty Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Giordano, PhD (318-349-3851, tgiordano@sulfagenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure using adverse events, clinical laboratory tests, vital signs and ECGs (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.