Using diazoxide to improve heart protection during cardiac surgery
Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial
This study is testing if adding diazoxide to a heart protection solution during cardiac surgery can help patients' hearts recover better and improve their overall outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06308107 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of adding diazoxide to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The study will involve thirty patients who will receive intravenous diazoxide in conjunction with their initial dose of cardioplegia, while subsequent doses will not include the additive. Researchers will assess safety through various measurements, including blood pressure and glucose levels, and evaluate efficacy by comparing heart function before and after surgery using echocardiograms. The goal is to determine if this combination can reduce myocardial stunning and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients with diabetes on sulfonylurea medications or those requiring mechanical circulatory support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance myocardial protection during cardiac surgery, leading to better recovery and outcomes for patients.
How similar studies have performed: While this approach is novel, similar studies exploring cardioplegia enhancements have shown promise in improving cardiac outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest * Patient scheduled for elective cardiac surgery * If female participant of childbearing potential, she must agree to and be able to use a highly effective method of birth control (eg, barrier contraceptives, hormonal contraceptives, intrauterine devices, or sexual abstinence) continuously for six days post- diazoxide dose Exclusion Criteria: * Patient with Diabetes Mellitus on sulfonylurea medications * Scheduled for left ventricular assist device (LVAD) or heart transplant * Left ventricular ejection fraction \< 30% * Pre-operative placement or planned use of mechanical circulatory support during surgery * Allergy to Thiazide and its derivatives * History of gout * Patient is pregnant or breastfeeding * Patients with seizure disorders controlled by diphenylhydantoin * Patients with a history of cold agglutinins
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Lawton, MD — Johns Hopkins University
- Study coordinator: Lisa Fornaresio, PhD
- Email: lisa.fornaresio@jhmi.edu
- Phone: 443.927.3984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.