Myocardial StunningPhase 1NCT04830982
Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
A Phase 1 study testing IV Diazoxide in people with Myocardial Stunning, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Stunning
- What is being tested?
- IV Diazoxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 30 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
- Patient scheduled for elective cardiac surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo Controlled Single Center Phase 1 Study to Evaluate Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.
Read the detailed description
This is a randomized blinded Phase I clinical trial. Thirty patients total will be randomized on a 2:1 basis to treatment (IV Diazoxide added to cardioplegia) vs control (cardioplegia alone). Diazoxide will be added to the first dose of cardioplegia only. Subsequent doses of cardioplegia will not contain additives.
- Conditions
- Myocardial Stunning
- Being tested
- IV Diazoxide, Placebo
- Medical subject headings
- Myocardial Stunning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV DiazoxideDrug
500 micromoles added to one liter of cardioplegia
PlaceboOther
Placebo added to one liter of cardioplegia
| Study group | Role | What they receive |
|---|---|---|
| Diazoxide | Experimental | IV Diazoxide as additive to hypothermic hyperkalemic cardioplegia. Receives: Drug: IV Diazoxide |
| Placebo | Placebo comparator | Placebo as additive to hypothermic hyperkalemic cardioplegia. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by mean change in blood pressure
Mean blood pressure measurements in mmHg.
Measured: From first dose of cardioplegia through 24 hours post operatively
Safety as assessed by change in blood glucose levels
Blood glucose levels in mg/dl.
Measured: From first dose of cardioplegia through 48 hours post operatively
Safety as assessed by incidence of adverse events
Safety will be assessed by total number of adverse events.
Measured: From first dose of cardioplegia through 7 days post operatively or discharge, whichever comes first
Secondary outcomes (4)
Efficacy as assessed by change in ejection fraction
Comparison of right and left ventricular function (measured as a percentage) on pre and post operative Transesophageal echocardiograms
Measured: Day of surgery (pre and post surgery)
Efficacy as assessed by use of mechanical circulatory support
Incidence of mechanical circulatory support use will be used in the assessment of efficacy.
Measured: 48 hours post operatively
Efficacy as assessed by change in Vasoactive Inotropic Score (VIS)
Comparison of VIS Score with values from 0 to >45, with lower scores indicating medication efficacy (0e5, >5e15, >15e30, >30e45, and >45 points).
Measured: 0, 24, 48 and 72 hours post operatively
Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB)
From time of first turn down of CPB to CPB end time measured in minutes.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Sep 2023 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Why it stopped: Withdrawn in IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial StunningStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Lawton, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830982
- Sponsor's protocol ID
- IRB00265542
- Status last verified
- Sep 2022
- First submitted
- 31 Mar 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled Single Center Phase 1 Study to Evaluate Safety and Efficacy of IV Diazoxide as an Additive to Hyperkalemic Cardioplegia in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT04830982
- Acronym / sponsor ID
- IRB00265542
- Conditions
- Myocardial Stunning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn in IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.
Detailed description
This is a randomized blinded Phase I clinical trial. Thirty patients total will be randomized on a 2:1 basis to treatment (IV Diazoxide added to cardioplegia) vs control (cardioplegia alone). Diazoxide will be added to the first dose of cardioplegia only. Subsequent doses of cardioplegia will not contain additives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diazoxide | Experimental | Drug: IV DiazoxideIV Diazoxide as additive to hypothermic hyperkalemic cardioplegia. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo as additive to hypothermic hyperkalemic cardioplegia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
- Patient scheduled for elective cardiac surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Diazoxide500 micromoles added to one liter of cardioplegia | Drug | Diazoxide |
| PlaceboPlacebo added to one liter of cardioplegia | Other | Placebo |
Primary outcome
Safety as assessed by mean change in blood pressure
Time frame: From first dose of cardioplegia through 24 hours post operatively
Mean blood pressure measurements in mmHg.
Safety as assessed by change in blood glucose levels
Time frame: From first dose of cardioplegia through 48 hours post operatively
Blood glucose levels in mg/dl.
Safety as assessed by incidence of adverse events
Time frame: From first dose of cardioplegia through 7 days post operatively or discharge, whichever comes first
Safety will be assessed by total number of adverse events.
4 secondary outcomes
Efficacy as assessed by change in ejection fraction
Time frame: Day of surgery (pre and post surgery)
Efficacy as assessed by use of mechanical circulatory support
Time frame: 48 hours post operatively
Efficacy as assessed by change in Vasoactive Inotropic Score (VIS)
Time frame: 0, 24, 48 and 72 hours post operatively
Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB)
Time frame: Day of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Lawton, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV Diazoxide in people with Myocardial Stunning, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by mean change in blood pressure (time frame: From first dose of cardioplegia through 24 hours post operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.