Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging

NCT04130438 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 47447
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed clinical trial is relevant to public health because it is expected to expand the differential diagnosis and provide an evidence--based therapy for the large population of patients with angina in the absence of obstructive CAD who currently remain undiagnosed and untreated. It, therefore, upholds an important part of the mission of the The National Heart, Lung, and Blood Institute (NHLBI), which is to promote the treatment of heart disease and enhance the health of all individuals so that they can live longer and more fulfilling lives.

Conditions

Myocardial Bridging

Outcome Measures

Primary Outcomes (1)

• Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)

  Effectiveness of beta blockers and calcium channel blockers for reducing angina in patients with a Myocardial Bridge (MB) compared to placebo determined after 30 days on the study drug by a change in angina, as assessed by the Seattle Angina Questionnaire (SAQ). The SAQ assesses 5 domains: physical limitation, angina stability angina frequency, treatment satisfaction, and quality of life. Each domain score is normalized to a range of 0 to 100, with higher scores corresponding to better outcomes.

  baseline and 30 days

Secondary Outcomes (6)

• Duke Treadmill Score by Risk Category

  baseline, 30 days

• Duke Treadmill Score

  baseline, 30 days

• Number of Participants With Cardiac Events

  30 days, 6 months

• Drug Adherence.

  30 days

• Number of Participants With Side Effects

  30 days

Study Arms (3)

Beta Blocker (nebivolol)

ACTIVE COMPARATOR

Drug: Nebivolol

Calcium Channel Blocker (diltiazem)

ACTIVE COMPARATOR

Drug: Diltiazem

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Nebivolol DRUG

The intervention to be tested is oral beta blocker (nebivolol 2.5 mg) vs. calcium channel blocker (Diltiazem-SR 120 mg) vs. placebo. Once enrolled, baseline data will be gathered and subjects will be randomly assigned to a treatment arm. Subjects will be instructed to take their assigned study drug once a day for 30 days.

Beta Blocker (nebivolol)

Diltiazem DRUG

The intervention to be tested is oral beta blocker (nebivolol 2.5 mg) vs. calcium channel blocker (Diltiazem-SR 120 mg) vs. placebo. Once enrolled, baseline data will be gathered and subjects will be randomly assigned to a treatment arm. Subjects will be instructed to take their assigned study drug once a day for 30 days.

Calcium Channel Blocker (diltiazem)

Placebo OTHER

The intervention to be tested is oral beta blocker (nebivolol 2.5 mg) vs. calcium channel blocker (Diltiazem-SR 120 mg) vs. placebo. Once enrolled, baseline data will be gathered and subjects will be randomly assigned to a treatment arm. Subjects will be instructed to take their assigned study drug once a day for 30 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Stable angina (typical or atypical, based on Diamond criteria (35))
• Exercise stress echocardiogram or exercise stress test (with beta blocker or calcium channel blocker held) performed within six months of enrollment
• CCTA or invasive coronary angiogram confirming the presence of an MB
• Absence of obstructive CAD, as demonstrated by no ischemia on stress testing and no significant obstructive CAD (coronary stenosis \<50%) on CCTA or invasive coronary angiogram

You may not qualify if:

• Asymptomatic
• Status--post heart transplant
• Presence of another likely explanation of chest pain, such as pulmonary hypertension, hypertrophic obstructive cardiomyopathy, or aortic stenosis
• Presence of an acute coronary syndrome (unstable angina, NSTEMI, or STEMI), Tako--tsubo, or cardiogenic shock
• An abnormal left ventricular ejection fraction (EF\<55%)
• Use of existing medication that has an unsafe drug--drug interaction with beta blockers or calcium channel blockers
• Refusal to take beta blockers or calcium channel blockers
• Resting systolic blood pressure \<100 mmHg or heart rate \<50 beats per minute
• Inability to provide an informed consent, including an inability to speak, read, or understand English or Spanish
• 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
• A potentially vulnerable subject (including pregnant women, prisoners, economically and educationally disadvantaged, decisionally impaired, and institutionalized individuals)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Shaw LJ, Peterson ED, Shaw LK, Kesler KL, DeLong ER, Harrell FE Jr, Muhlbaier LH, Mark DB. Use of a prognostic treadmill score in identifying diagnostic coronary disease subgroups. Circulation. 1998 Oct 20;98(16):1622-30. doi: 10.1161/01.cir.98.16.1622.

  PMID: 9778327 BACKGROUND

MeSH Terms

Conditions

Myocardial Bridging

Interventions

Nebivolol; Diltiazem

Condition Hierarchy (Ancestors)

Coronary Vessel Anomalies; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines

Limitations and Caveats

Early termination led to a small number of subjects analyzed.

Results Point of Contact

• Title: Jennifer A. Tremmel, MD, MS
• Organization: Stanford University

nocad_study@stanford.edu

(650) 723-0180

Study Officials

• Jennifer Tremmel, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional cardiologist

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: October 17, 2019
• Study Start: October 15, 2020
• Primary Completion: March 11, 2022
• Study Completion: October 17, 2024
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)