Medical Therapy for Myocardial Bridging

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must be taking: Beta blockers, Calcium channel blockers

Must not be taking: Unsafe drug interactions

Disqualifiers: Heart transplant, Pulmonary hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two heart medications, diltiazem and nebivolol, to determine their effectiveness for people with chest pain (angina) not caused by blocked arteries. The goal is to find a treatment for myocardial bridging, a condition where a heart artery is squeezed during a heartbeat without typical artery blockages. Suitable candidates for this trial are those with chest pain confirmed by a recent heart test, but without major artery blockages. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that have unsafe interactions with beta blockers or calcium channel blockers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found diltiazem to be generally safe and well-tolerated, with less than 5% of patients experiencing side effects while using it for heart conditions. Research on nebivolol shows it is also safe and effective in lowering blood pressure and helping prevent organ damage. Both treatments have been used in patients with heart issues, and studies suggest they are safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using diltiazem and nebivolol for treating myocardial bridging because they offer new ways to manage this condition. Diltiazem, a calcium channel blocker, works by relaxing and widening blood vessels, which can help reduce the pressure caused by myocardial bridging. Nebivolol, a beta blocker, is unique because it not only slows the heart rate but also has vasodilating properties, meaning it can help widen blood vessels, potentially offering dual benefits. Unlike standard treatments that primarily focus on reducing heart rate and contractility, these medications could provide a more comprehensive approach by addressing both heart rate and vessel flexibility, which might enhance overall heart function.

What evidence suggests that this trial's treatments could be effective for angina?

This trial will compare the effects of diltiazem and nebivolol on myocardial bridging. Studies have shown that diltiazem, a calcium channel blocker, can improve heart health by reducing the frequency of heart muscle squeezing. This squeezing, common in individuals with myocardial bridging, can cause chest pain. One study found that people taking diltiazem lived longer. Nebivolol, a beta blocker, may help by improving blood vessel function. It targets specific heart problems more effectively. Some research suggests that nebivolol can also reduce chest pain in individuals with heart issues. Participants in this trial will receive either diltiazem, nebivolol, or a placebo to assess their effectiveness. ^{1 5 6 7 8}

Who Is on the Research Team?

Jennifer Tremmel, MD, MS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

You have stable chest pain that fits specific criteria.

You do not have blockages in your heart arteries, as shown by specific tests.

You have had an exercise stress test in the past six months.

Exclusion Criteria

A hearing impairment that won't allow for a typical verbal conversation or a visual impairment that won't allow for reading of the written consent

Inability to provide an informed consent, including an inability to speak, read, or understand English or Spanish

Your heart has a lower than normal pumping ability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three treatment arms: beta blocker (nebivolol), calcium channel blocker (diltiazem), or placebo for 30 days

4 weeks

1 visit (in-person) at baseline, 1 visit (in-person) at 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of angina and exercise capacity

6 months

1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Diltiazem
• Nebivolol
• Placebo

How Is the Trial Designed?

Group I: Beta Blocker (nebivolol) Active Control 1 Intervention

Group II: Calcium Channel Blocker (diltiazem) Active Control 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Diltiazem is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Cardizem for:

• Hypertension
• Angina pectoris
• Atrial fibrillation
• Supraventricular tachycardia

Approved in Canada as Dilacor for:

• Hypertension
• Angina pectoris
• Atrial fibrillation
• Supraventricular tachycardia

Approved in European Union as Tiazac for:

• Hypertension
• Angina pectoris
• Atrial fibrillation
• Supraventricular tachycardia

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study involving 22 patients with dilated cardiomyopathy, the addition of diltiazem to standard therapy significantly improved survival rates, with no deaths in the diltiazem group over a mean follow-up of 15.4 months, compared to a mean survival of 29 months in historical controls.

Diltiazem treatment also led to a significant increase in left ventricular ejection fraction from 0.34 to 0.44 and improved symptoms according to the New York Heart Association classification, indicating its beneficial effects on heart function and patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Beneficial long-term effects of diltiazem on the course of dilated cardiomyopathy]. Figulla, HR., von Rechenberg, J., Wiegand, V., et al.[2013]

In a study of 51 hypertensive patients with vasospastic angina, both nebivolol and diltiazem significantly reduced coronary vasospasm over a 12-week period, but diltiazem was more effective than nebivolol.

Quality of life, as measured by the Seattle Angina Questionnaire, improved for all patients, but there were no significant differences in quality of life or blood pressure changes among the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of nebivolol versus diltiazem in improving coronary artery spasm and quality of life in patients with hypertension and vasospastic angina: A prospective, randomized, double-blind pilot study. Kook, H., Hong, SJ., Yang, KS., et al.[2020]

In a study of 30 patients with dilated cardiomyopathy who were not responding well to metoprolol, switching to carvedilol for 12 months led to significant improvements in left ventricular function, including a better ejection fraction and reduced heart size.

While carvedilol showed benefits in heart function and reduced arrhythmias, it negatively impacted exercise capacity, indicating that while it can be effective for heart remodeling, it may not improve overall exercise tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of carvedilol in idiopathic dilated cardiomyopathy with persistent left ventricular dysfunction despite chronic metoprolol. The Heart-Muscle Disease Study Group. Di Lenarda, A., Sabbadini, G., Salvatore, L., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11706257/

Coronary vasospasm and cardiovascular outcomes in ... The primary endpoints were major adverse cardiovascular events (MACEs), a composite of cardiac death, cardiac arrest, non-fatal myocardial infarction, ischemia- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7386550/

Myocardial Bridging: A Case Presentation of Atypical Chest ... They have the added benefit of reducing heart rates, thus decreasing the frequency of systolic compression and increasing the diastolic period. Ivabradine has ...

3. withpower.com withpower.com/trial/phase-3-myocardial-bridging-9-2020-3b044

Medical Therapy for Myocardial Bridging · Info for Participants In a study involving 22 patients with dilated cardiomyopathy, the addition of diltiazem to standard therapy significantly improved survival rates, with no ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666084925008289

A Case of Exercise-Induced Cardiac Arrest With Coronary ... Outcome and Follow-Up ... The postoperative course was uneventful, with no recurrence of ischemic symptoms/signs. Three months after surgery, an ...

5. dovepress.com dovepress.com/a-case-of-symptomatic-myocardial-bridge-treated-with-calcium-channel-b-peer-reviewed-fulltext-article-IMCRJ

Myocardial bridge treated with calcium channel blocker We report a case of symptomatic MB in a 44-year-old man with compression of the anterior descending artery on each systole of the cardiac cycle.

6. eymj.org eymj.org/DOIx.php?id=10.3349/ymj.2017.58.1.90

Impact of Diltiazem Alone versus Diltiazem with Nitrate ... The main finding of the present study is that there is no significant difference in clinical outcomes, including MACE and recurrent angina ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9017457/

Therapeutic Dilemmas Faced When Managing a Life- ... Most myocardial bridges are asymptomatic, but some can result in myocardial ischaemia, arrhythmias, and sudden cardiac death.

8. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-021-02382-y

Is myocardial bridge more frequently detected on radial ... The results of this study showed the incidence of MB to be 10.2% in patients undergoing RACA, which was significantly higher than that detected ...