Trial · NCT04777045
Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: a Randomized Clinical Trial
NCT04777045, Phase 3, Active not recruiting, Radboud University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: a Randomized Clinical Trial. Trials, record NCT04777045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04777045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: a Randomized Clinical Trial
- NCT number
- NCT04777045
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 85 participants, estimated
- Lead sponsor
- Radboud University Medical Center
- Conditions
- Microvascular Angina, Coronary Vasospasm, Microvascular Ischemia of Myocardium
- Interventions
- Diltiazem Hydrochloride, Placebo
- First posted
- 2021-03-02
- Last updated
- 2023-03-30
- Other registries' IDs
- eudract:2018-003518-41
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of patients having a successful treatment with diltiazem, defined as normalization of at least one abnormal parameter and none of the normal parameters becoming abnormal. | 6 weeks | A normal IMR is specified as IMR \< 25, a normal CFR being a CFR \> 2 and a normal acetylcholine test is specified as one without spasm, without ischemic ECG abnormalities and without (recognizable) angina at the same acetylcholine dose used at baseline. |
| Secondary | Change in index of microvascular resistance (IMR) | 6 weeks | the delta between 1st and 2nd coronary function test |
| Secondary | Change in Coronary Flow Reserve (CFR) | 6 weeks | the delta between 1st and 2nd coronary function test |
| Secondary | Change in Acetylcholine test parameters | 6 weeks | his is defined as the difference between the dose of acetylcholine at which the baseline CFT showed signs of spasm, compared to the dose at the second CFT. This will be compared between treatment and placebo group using a multinominal logistic regression. The efficacy population will be used for this analysis. |
| Secondary | Change in Absolute flow parameters - flow (Q) (ml/min) | 6 weeks | These are derived by subtracting the outcome from the second CFT from the outcome of the first CFT. To compare change in CFT parameters between treatment and placebo group, we will use independent sample t-test. Bonferroni correction will be applied to account for multiple testing. The efficacy population will be used for this analysis. |
| Secondary | Change in Absolute flow parameters - Resistance (R) | 6 weeks | These are derived by subtracting the outcome from the second CFT from the outcome of the first CFT. To compare change in CFT parameters between treatment and placebo group, we will use independent sample t-test. Bonferroni correction will be applied to account for multiple testing. The efficacy population will be used for this analysis. |
| Other | Safety endpoints | 6 weeks | The occurrence of complications related to the coronary angiography and/or CFT will be collected, as well as adverse events related to the IMP. |
| Other | Follow-up (MACE) | 5 years | Number of major adverse cardiovascular events (MACE) at 1 and 5 year follow-up. MACE is defined as nonfatal stroke, nonfatal myocardial infarction, cardiovascular death, all-cause death, hospitalization for heart failure. |
| Other | Change in angina frequency reporting in the patient diary | 5 years | Change in patient reported outcome measures (PROs). These are derived by subtracting the outcome from the PROs from visit 104 to those from visit 1. The efficacy population will be used for this analysis.To compare change in PROs between treatment and placebo group, we will use independent sample t-test. |
| Other | Change in the Seattle Angina Questionnaire (SAQ) | 5 years | Change in patient reported outcome measures (PROs). These are derived by subtracting the outcome from the PROs from visit 104 to those from visit 1. The efficacy population will be used for this analysis.To compare change in PROs between treatment and placebo group, we will use independent sample t-test. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04777045
GET https://conductscience.org/api/trials/v1/NCT04777045/registered