NCT02278276

A Randomised, Double-blinded, Placebo-controlled Study to Assess the Safety and Bioactivity of Sodium Polysulthionate (SG1002) in Heart Failure Patients

Status unknown Phase 1/Phase 2 Last updated 25 November 2015

What this trial tests

Phase 1/Phase 2 trial testing sodium polysulthionate in Heart Failure in 50 participants. Status unknown.

Timeline

1 April 2016

Primary endpoint
1 April 2018

1 July 2018

Quick facts

Lead sponsor	Sulfagenix Australia Pty Ltd.
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	1 April 2016
Primary completion	1 April 2018
Estimated completion	1 July 2018

Drugs / interventions tested

• sodium polysulthionate — full drug profile →
• Placebo

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Sulfagenix Australia Pty Ltd. — full company profile →

Who can join

Adults 35 to 85, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 o

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ATF-4 and hydrogen sulfide signalling mediate longevity in response to inhibition of translation or mTORC1.
   Statzer C, Meng J, Venz R, Bland M, et al · · 2022 · cited 91× · PMID 35181679 · DOI 10.1038/s41467-022-28599-9
2. Perivascular adipose tissue as a regulator of vascular disease pathogenesis: identifying novel therapeutic targets.
   Akoumianakis I, Tarun A, Antoniades C. · · 2017 · cited 57× · PMID 27976387 · DOI 10.1111/bph.13666
3. The dichotomous role of H₂S in cancer cell biology? Déjà vu all over again.
   Kashfi K. · · 2018 · cited 44× · PMID 29397935 · DOI 10.1016/j.bcp.2018.01.042
4. ARDD 2020: from aging mechanisms to interventions.
   Mkrtchyan GV, Abdelmohsen K, Andreux P, Bagdonaite I, et al · · 2020 · cited 40× · PMID 33378272 · DOI 10.18632/aging.202454
5. The Role of Hydrogen Sulfide in Respiratory Diseases.
   Khattak S, Zhang QQ, Sarfraz M, Muhammad P, et al · · 2021 · cited 39× · PMID 34062820 · DOI 10.3390/biom11050682
6. Emerging role of hydrogen sulfide-microRNA crosstalk in cardiovascular diseases.
   Hackfort BT, Mishra PK. · · 2016 · cited 32× · PMID 26801305 · DOI 10.1152/ajpheart.00660.2015
7. H₂S in acute lung injury: a therapeutic dead end(?).
   Merz T, Denoix N, Wepler M, Gäßler H, et al · · 2020 · cited 12× · PMID 33336306 · DOI 10.1186/s40635-020-00324-0
8. Reactive Sulfur Species and Protein Persulfidation: An Emerging Redox Axis in Human Health and Disease.
   Andrés CMC, Lobo F, Lastra JMP, Munguira EB, et al · · 2025 · cited 7× · PMID 41020887 · DOI 10.3390/cimb47090765