Assessing the Safety and Bioactivity of SG1002 in Heart Failure Patients

NCT02278276 | Unknown Phase 1

• 1 other identifier: Sulfagenix-SG1002-002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Composite measure using adverse events, clinical laboratory tests, vital signs and ECGs

  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.

  3 months

Secondary Outcomes (5)

• Heart function

  3 months

• Body mass and waste circumference

  3 months

• Biomarkers of inflammation and oxidative stress

  3 months

• Walking distance in 6 minute

  3 months

• Minnesota Heart Failure Questionnaire

  3 months

Study Arms (2)

0 mg SG1002

PLACEBO COMPARATOR

Capsules containing 400 mg of placebo will be provided to subjects. Subjects will take two tablets twice each day.

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.

Drug: sodium polysulthionate

Interventions

sodium polysulthionate DRUG

Bioavailable composition of α-sulfur

1600 mg SG1002

Placebo DRUG

400 mg capsules containing placebo

0 mg SG1002

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Sulfagenix Australia Pty Ltd.: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tony Giordano, PhD

  Sulfagenix Australia Pty Ltd.

  STUDY DIRECTOR

Central Study Contacts

Tony Giordano, PhD

CONTACT

318-349-3851; tgiordano@sulfagenix.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 29, 2014
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 26, 2015

Record last verified: 2015-11