Heart FailureNCT01989208
Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients
A study testing SG1002 in people with Heart Failure, run by Sulfagenix Australia Pty Ltd. at 2 sites in Australia.
Trial summary
Patients with heart failure are reported to have lower levels of hydrogen sulfide in their blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule that has been shown to have a number of beneficial effects and thus the low levels may contribute to the disease. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- SG1002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesAustralia
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers aged between 18 and 45 years (inclusive);
- Body mass index between 19 and 30 kg/m^2 (inclusive);
- No clinically significant findings in the medical history and physical examination;
- No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
- Normal ECG, blood pressure and heart rate, unless the Investigator considers any abnormality to be not clinically significant (NCS);
- Willing to use contraception (single barrier methods); and
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- Willing and able to provide written informed consent.
- Aged between 35 and 85 years (inclusive);
- Has symptomatic heart failure, with New York Heart Association (NYHA)classification of II or III;
- Ambulatory;
- Left ventricular ejection fraction less than 40%;
- Congestive heart failure 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); and
- Willing and able to provide written informed consent.
Who cannot join
- Have received blood products within 1 month prior to Screening;
- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of trial medical food;
- Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the trial medical food;
- Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months;
- Have had serious angioedema episodes within the previous 3 years or requiring medication in the previous two years;
- Have a bleeding disorder diagnosed by a doctor (for example factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties during blood draws;
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- Have a psychiatric condition that precludes compliance with the protocol, past or present psychoses, past or present bipolar disorder, or a disorder requiring lithium, within five years prior to enrolment;
- Has a history of suicide plan;
- Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse;
- Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk;
- HIV, or hepatitis B or C positive;
- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder;
- Have a history of or current tuberculosis, epilepsy, diabetes or glaucoma;
- Have clinical signs of active infection or a temperature more than 38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator;
- Have evidence of drug or alcohol abuse;
- Be unable to provide repeated blood samples without undue trauma or distress;
- Anticipate surgery within the trial period; or
- Inability to speak English (due to need to administer standardized English-language questionnaire).
- Subject is pregnant or breastfeeding;
- If female, the subject is 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;
- Myocardial infarction, unstable angina, stroke, cerebrovascular accident, percutaneous coronary intervention, open heart surgery or transient ischemic attack (TIA) within 3 months prior to Screening;
- Current symptomatic hypotension (defined as systolic blood pressure (SBP) ≤ 90 mmHg or diastolic blood pressure (DBP) ≤ 40 mmHg);
- Poorly controlled hypertension (defined as SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) despite therapy
- Subjects with NYHA grade IV heart failure;
- Subjects awaiting percutaneous coronary intervention or open heart surgery;
- Subjects with serious liver disease;
- Subjects with liver function test results three times the upper limit of normal.
- Any change in cardiovascular drug therapy within three months prior to randomization
- History of chronic obstructive pulmonary disease (diagnosed using GOLD criteria) or evidence of restrictive lung disease (defined as forced expiratory volume (FEV1) to forced vital capacity (FCV) ratio of > 80%);
- Poorly controlled diabetes (defined as HbA1c > 10.0 %);
- Has undergone Cardiac Resynchronisation Therapy (CRT) in the last 6 months and no planned CRT;
- Implantable cardioverter defibrillator (ICD) implant planned during the study;
- Hypersensitivity to sulfur or related compounds;
- Renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) < 30 mL/minute/1.73 m2 (Modification of Diet in Renal Disease Study MDRD) [2];
- Life expectancy less than 6 months;
- 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.)
- Inability to speak English (due to need to administer standardized English-language questionnaire); or
- Any other chronic illness that may, in the opinion of the Investigator, increase the risks associated with this trial.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Alfred Health
Melbourne, Victoria, 3004
Nucleus Network
Melbourne, Victoria, 3004
About this study
Official title: A Dose Escalation Study to Assess the Safety and Ability of SG1002 to Overcome Circulating Deficits in Hydrogen Sulfide Found in Heart Failure Patients
Patients with heart failure are reported to have lower levels of hydrogen sulfide in their blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule that has been shown to have a number of beneficial effects and thus the low levels may contribute to the disease. This trial is testing whether a medical food product of synthetic sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.
Read the detailed description
Subjects with heart failure have been shown to have a deficit in circulating hydrogen sulfide levels, which, since sulfur is not readily bioavailable and is declining in food substances, cannot be treated adequately by diet alone. This deficit in circulating hydrogen sulfide is thought to lead to increases in oxidative stress and with this, associated problems that can contribute to heart failure. This is a study to evaluate the safety and ability of multiple doses of oral SG1002 in subjects with heart failure to reverse the deficits in circulating hydrogen sulfide. The primary objective is to assess the safety and the ability of multiple doses of twice daily administration of SG1002 compared with placebo to increase circulating levels of hydrogen sulfide. Initially, a dose escalation study will be carried out for 21 days in 4 normal subjects, randomized 3:1 active:placebo. Subjects will receive a 200 mg dose BID for 7 days and in no adverse events, escalate to 400 mg for 7 days then 800 mg for 7 days. Safety parameters will be assessed for each dose, along with pharmacokinetic analysis and markers of oxidative stress and heart failure. Following completion of the normal healthy subjects, 10 heart failure subjects will be randomized 4:1 active:placebo and tested as described above.
- Conditions
- Heart Failure
- Being tested
- SG1002, Placebo
- Keywords
- Heart Failure, Congestive Heart Failure, Oxidative Stress, Hydrogen Sulfide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG1002Other
Also called alpha sulfur/sodium sulfate
200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.
PlaceboOther
200 mg capsules containing placebo will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Sugar capsule | Placebo comparator | One normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period. Receives: Other: Placebo |
| SG1002 | Experimental | 200 mg capsule of SG1002 (alpha sulfur/sodium sulfate) Receives: Other: SG1002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events
The number of subjects reporting Treatment Emergent Adverse Events at any time during the study period.
Measured: Following 7 days of treatment at each of three doses
Secondary outcomes (1)
Assessing Changes in Peak Hydrogen Sulfide Levels in Heart Failure Subjects Following SG1002 Administration.
At the start of each dose, blood samples will be obtained and circulating hydrogen sulfide levels will be assessed over a 24 hour period to determine whether SG1002 can overcome the deficits reported in heart failure patients. Peak hydrogen sulfide levels were measured during the first 4 hours post-administration when maximum concentrations of hydrogen sulfide were reached.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sulfagenix Australia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, MD, PhD, Principal investigator, Nucleus NetworkHenry Krum, MBBS, PhD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989208
- Sponsor's protocol ID
- SG1002-001
- Status last verified
- Apr 2020
- First submitted
- 13 Nov 2013
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Polhemus DJ, Li Z, Pattillo CB, Gojon G Sr, Gojon G Jr, Giordano T, Krum H. A novel hydrogen sulfide prodrug, SG1002, promotes hydrogen sulfide and nitric oxide bioavailability in heart failure patients. Cardiovasc Ther. 2015 Aug;33(4):216-26. doi: 10.1111/1755-5922.12128.
PubMed 25930144
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study to Assess the Safety and Ability of SG1002 to Overcome Circulating Deficits in Hydrogen Sulfide Found in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01989208
- Acronym / sponsor ID
- SG1002-001
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Congestive Heart Failure, Oxidative Stress, Hydrogen Sulfide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sulfagenix Australia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with heart failure are reported to have lower levels of hydrogen sulfide in their blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule that has been shown to have a number of beneficial effects and thus the low levels may contribute to the disease. This trial is testing whether a medical food product of synthetic sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.
Detailed description
Subjects with heart failure have been shown to have a deficit in circulating hydrogen sulfide levels, which, since sulfur is not readily bioavailable and is declining in food substances, cannot be treated adequately by diet alone. This deficit in circulating hydrogen sulfide is thought to lead to increases in oxidative stress and with this, associated problems that can contribute to heart failure. This is a study to evaluate the safety and ability of multiple doses of oral SG1002 in subjects with heart failure to reverse the deficits in circulating hydrogen sulfide. The primary objective is to assess the safety and the ability of multiple doses of twice daily administration of SG1002 compared with placebo to increase circulating levels of hydrogen sulfide. Initially, a dose escalation study will be carried out for 21 days in 4 normal subjects, randomized 3:1 active:placebo. Subjects will receive a 200 mg dose BID for 7 days and in no adverse events, escalate to 400 mg for 7 days then 800 mg for 7 days. Safety parameters will be assessed for each dose, along with pharmacokinetic analysis and markers of oxidative stress and heart failure. Following completion of the normal healthy subjects, 10 heart failure subjects will be randomized 4:1 active:placebo and tested as described above.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar capsule | Placebo comparator | Other: PlaceboOne normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period. |
| SG1002 | Experimental | Other: SG1002200 mg capsule of SG1002 (alpha sulfur/sodium sulfate) |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy male volunteers aged between 18 and 45 years (inclusive);
- Body mass index between 19 and 30 kg/m^2 (inclusive);
- No clinically significant findings in the medical history and physical examination;
- No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
- Normal ECG, blood pressure and heart rate, unless the Investigator considers any abnormality to be not clinically significant (NCS);
Key exclusion criteria (38 listed)
- Have received blood products within 1 month prior to Screening;
- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of trial medical food;
- Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the trial medical food;
- Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months;
- Have had serious angioedema episodes within the previous 3 years or requiring medication in the previous two years;
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 |
|---|---|---|
| SG1002Also: alpha sulfur/sodium sulfate200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days. | Other | SG1002 |
| Placebo200 mg capsules containing placebo will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days. | Other | Sugar capsule |
Primary outcome
Number of Subjects With Adverse Events
Time frame: Following 7 days of treatment at each of three doses
The number of subjects reporting Treatment Emergent Adverse Events at any time during the study period.
1 secondary outcome
Assessing Changes in Peak Hydrogen Sulfide Levels in Heart Failure Subjects Following SG1002 Administration.
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25930144Polhemus DJ, Li Z, Pattillo CB, Gojon G Sr, Gojon G Jr, Giordano T, Krum H. A novel hydrogen sulfide prodrug, SG1002, promotes hydrogen sulfide and nitric oxide bioavailability in heart failure patients. Cardiovasc Ther. 2015 Aug;33(4):216-26. doi: 10.1111/1755-5922.12128.
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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.
Jason Lickliter, MD, PhD principal investigator
Nucleus Network
Henry Krum, MBBS, PhD principal investigator
The Alfred
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SG1002 in people with Heart Failure, run by Sulfagenix Australia Pty Ltd. at 2 sites in Australia.
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 13 inclusion and 38 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: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events (time frame: Following 7 days of treatment at each of three doses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01989208, which also lists 1 linked publication.
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 5 May 2020.