Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients

Heart Failure Clinical Trial

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

Status Completed

Clinical 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. This trial is testing whether a medical food product of synthetic sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT01989208
• Study type: Interventional
• Source: Sulfagenix Australia Pty Ltd.
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: December 2014