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| ID | Type | Description | Link |
|---|---|---|---|
| 24POST1189688 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing.
Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted medical therapy | Experimental |
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study. |
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| Placebo | Placebo Comparator |
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 1-3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for an additional 4 weeks to the conclusion of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated. |
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| Measure | Description | Time Frame |
|---|---|---|
| Seattle Angina Questionnaire summary score | Change in Seattle Angina Questionnaire summary score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol 5 dimension - 5L index score | Change in EuroQol 5 dimension score - 5L index score at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| EuroQol 5 dimension - 5L visual analogue score |
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Inclusion Criteria:
Specific inclusion criteria for randomization:
And ≥ 1 of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Wong, MBBS, PhD | Contact | (650) 725 5909 | ccywong@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Tremmel, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017566 | Microvascular Angina |
| D000788 | Angina Pectoris, Variant |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nebivolol | Drug | Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated. |
|
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| Placebo | Drug | Placebo taken once orally daily. |
|
Change in EuroQol 5 dimension score - 5L visual analogue score at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome. |
| 5-7 weeks (depending on drug titration period) |
| PHQ-4 score | Change in PHQ-4 at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome. | 5-7 weeks (depending on drug titration period) |
| Treatment Satisfaction Questionnaire for Medication score | Change in Treatment Satisfaction Questionnaire for Medication score at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes | Change in Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes | EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes | EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes at follow-up compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| PHQ-4 scores stratified by specific chest pain endotypes | PHQ-4 score stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome. | 5-7 weeks (depending on drug titration period) |
| Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes | Treatment Satisfaction Questionnaire for Medication scores stratified by specific chest pain endotypes at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| Seattle Angina Questionnaire summary score stratified by baseline angina frequency | Change in Seattle Angina Questionnaire summary score stratified by baseline angina frequency at at follow-up compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 5-7 weeks (depending on drug titration period) |
| Proportion of patients with good response, no angina, and excellent health status | Difference between targeted medical therapy group and placebo group in proportion of patients with good response (Seattle Angina Questionnaire summary score ≥ 10), no angina (Seattle Angina Questionnaire angina frequency score = 100), and excellent health status (Seattle Angina Questionnaire summary score ≥ 75). | 5-7 weeks (depending on drug titration period) |
| Safety endpoints | Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure | Baseline |
| Major adverse cardiac events | Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina. | 5-7 weeks (depending on drug titration period) |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000789 | Angina, Unstable |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |