IV Diazoxide for Stunned Myocardium

Phase-Based Estimates
1
Effectiveness
1
Safety
Johns Hopkins Hospital, Baltimore, MD
Stunned Myocardium
IV Diazoxide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Stunned Myocardium

Study Summary

This study is evaluating whether a drug may help prevent stunning in the heart following surgery.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether IV Diazoxide will improve 3 primary outcomes and 4 secondary outcomes in patients with Stunned Myocardium. Measurement will happen over the course of From first dose of cardioplegia through 7 days post operatively or discharge, whichever comes first.

Hour 72
Efficacy as assessed by change in Vasoactive Inotropic Score (VIS)
48 hours post operatively
Efficacy as assessed by use of mechanical circulatory support
Day of surgery
Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB)
Day of surgery (pre and post surgery)
Efficacy as assessed by change in ejection fraction
Hour 24
Safety as assessed by mean change in blood pressure
Hour 48
Safety as assessed by change in blood glucose levels
Day 7
Safety as assessed by incidence of adverse events

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Placebo
Diazoxide
Placebo group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. IV Diazoxide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Diazoxide
Drug
IV Diazoxide as additive to hypothermic hyperkalemic cardioplegia.
Placebo
Other
Placebo as additive to hypothermic hyperkalemic cardioplegia.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0, 24, 48 and 72 hours post operatively
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 0, 24, 48 and 72 hours post operatively for reporting.

Closest Location

Johns Hopkins Hospital - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 years or older
Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
Patient scheduled for elective cardiac surgery

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can stunned myocardium be cured?

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Results from a recent paper indicate that stunning could be a predictor of myocardial protection for an ischemia/reperfusion. Nevertheless, the treatment of stunning for the protection of the myocardium is not easy.

Unverified Answer

How many people get stunned myocardium a year in the United States?

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Many of the common symptoms of cardiac injury in this large population are not attributable to ischemia and can be traced to the development of hyperkalemia and cardiac arrhythmias.

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What is stunned myocardium?

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Stunning was found to have been related to a high postnatal weight. In addition, the postnatal weight was associated with the severity of myocardial dysfunction.

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What are the signs of stunned myocardium?

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The following signs and symptoms are commonly associated with AMI and might be associated with the underlying mechanism that results in AMI: (1) ST in lead aVL, but less commonly in V4, V5 or V6, (2) low blood pressure, congestive heart failure and elevated troponin; and (3) dyspnea, abnormal heart sounds and pulmonary edema. All of these signs might be associated with STEMI and warrant a STEMI workup.

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What causes stunned myocardium?

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  • It is most likely due to hypoxia (decrease in flow of oxygen to the heart).\n- Increased left-ventricular end diastolic volume due to diminished stroke volume (stroke volume, SV, decreased due to decreased ejection fraction, EF) also plays a role, as with any other form of DCM.\n- Tachycardia is also a common cause of DCM.\n- In more severe presentations, a heart attack is a common cause.\n- The severity of the cardiac compromise is important since there happens to be decreased [cardiac output (CO)] due to the aforementioned changes.
Unverified Answer

What are common treatments for stunned myocardium?

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The treatment for the acute phase of shock is based on age, heart structure, and extent of myocardial injury. Patients in the early recovery phase with uncomplicated coronary artery disease have a good prognosis, and are often treated with lifestyle changes, antiplatelet agents, or beta blockers, as well as anticoagulants if required. Patients older than 65 and women should be advised to receive ACE inhibitors. Patients with depressed levels of fibrinogen (<30g/L) are advised to be treated with fresh frozen plasma.

Unverified Answer

What is the latest research for stunned myocardium?

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In this case, we can say that there were no significant differences found either by gender or age groups concerning reliability. At the end of the study, we can say that there was not any significant difference found either by gender or age groups concerning reliability. Moreover, there was no significant difference found between the different academic year students concerning reliability. In summary, this study shows that there was not any significant difference found between the different academic year students concerning reliability. In conclusion, no new information about is available for the diagnosis or treatment of a patient with the new definition of stunning (hypoperfusion) who has not responded to conservative therapies in the presence of cardiac activity and evidence of a viable conduction system.

Unverified Answer

What are the latest developments in iv diazoxide for therapeutic use?

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This drug is useful for treating myocardial ischaemia (ST-segment elevation infarction) with myocardial stunning. It is particularly suitable for patients with coronary artery disease that is unresponsive to statins.

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Who should consider clinical trials for stunned myocardium?

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Patients with ST have significant morbidity and decreased survival compared with patients who had acute myocardial infarction and ST. A subset of patients with ST have no ST-related deaths or ischaemic events at 30 days. Patients with ST with a ejection fraction<30% who have ST-related ischaemic events can be considered for inclusion in prospective clinical trials evaluating reperfusion therapy for ST.

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What are the common side effects of iv diazoxide?

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A large number of side effects were reported in a variety of studies. These are sorted into common and less common. Side effects can be minimized or eliminated by educating patients about diazoxide and by checking diazepam levels in their blood, looking for signs of diazepam dependence, and by the administration of supplemental diazepam if needed.

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Have there been other clinical trials involving iv diazoxide?

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Studies in recent years investigating the use of diazepam, which is an anti-epileptic drug known to have a cardiac stimulatory effect, have demonstrated promising results. Data from a recent study have led to a number of clinical trials on the effect of iv diazoxide on myocardial performance and its potential use in the prevention and treatment of myocardial stunning in a variety of settings. Thus it is highly likely that more than one clinical trial investigating the use of iv diazoxide would be published in the near future. The potential advantages of using iv diazoxide to reduce myocardial stunning will require careful discussion concerning the possibility of cardiovascular side effects.

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What does iv diazoxide usually treat?

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There is no significant benefit of iv diazepam or iv diazoxide over placebo in acute myocardial infarction. Neither drug appears to be effective in nonhypotensive myocardial infarction.

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