Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease
NCT ID: NCT05294887
Last Updated: 2022-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
132 participants
INTERVENTIONAL
2022-03-04
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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bisoprolol first, diltiazem second
Crossover Design: bisoprolol first, diltiazem second, placebo third
Bisoprolol
beta-adrenergic receptor blocker
Diltiazem
calcium channel blocker
Placebo
Placebo
bisoprolol first, placebo second
Crossover Design: bisoprolol first, placebo second, diltiazem third
Bisoprolol
beta-adrenergic receptor blocker
Diltiazem
calcium channel blocker
Placebo
Placebo
diltiazem first, bisoprolol second
Crossover Design: diltiazem first, bisoprolol second, placebo third
Bisoprolol
beta-adrenergic receptor blocker
Diltiazem
calcium channel blocker
Placebo
Placebo
diltiazem first, placebo second
Crossover Design: diltiazem first, placebo second, bisoprolol third
Bisoprolol
beta-adrenergic receptor blocker
Diltiazem
calcium channel blocker
Placebo
Placebo
placebo first, bisoprolol second
Crossover Design: placebo first, bisoprolol second, diltiazem third
Bisoprolol
beta-adrenergic receptor blocker
Diltiazem
calcium channel blocker
Placebo
Placebo
placebo first, diltiazem second
Crossover Design: placebo first, diltiazem second, bisoprolol third
Bisoprolol
beta-adrenergic receptor blocker
Diltiazem
calcium channel blocker
Placebo
Placebo
Interventions
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Bisoprolol
beta-adrenergic receptor blocker
Diltiazem
calcium channel blocker
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recurrent angina symptoms provoked by exercise and/or repeated attacks of angina at rest (both at least for 4 weeks)
* Absence of flow-limiting coronary artery stenosis (as defined by any coronary artery diameter reduction \>50% or fractional flow reserve ≤0.80)
* Left ventricular ejection fraction (LVEF) \>50%
* Written informed consent
Exclusion Criteria
* Female patients of childbearing potential who are unwilling to use a highly effective contraception method during trial participation according to CTFG. In addition, a negative serum or urine pregnancy test must be available prior to randomization.
* Expected life expectancy \<1 year
* Contraindications to withholding nitrates, calcium channel blockers, and beta blockers for 48 hours before invasive coronary reactivity testing (e.g. clinical need for rate control in case of permanent atrial fibrillation, recurrent angina symptoms without any possibility to wihthold ongoing medication)
* Known hypersensitivity or contraindication to bisoprolol or diltiazem or any of its excipients.
* Concomitant therapy with systemic drugs that are strong inhibitors of both CYP3A4 and P-gp (azole antimycotics such as ketoconazole and itraconazole or HIV protease inhibitors such as ritonavir)
* Concomitant therapy with drugs that are strong CYP3A4 inducers (e.g. carbamazepine, phenytoin, rifampicin, St. John's wort)
* Bradycardia (\<50/min) at time of randomization
* Symptomatic hypotension (\<100 mmHg) at time of randomization
* Cardiogenic shock
* Second and third degree atrioventricular block, sick sinus syndrome, sinoatrial block
* Severe valvular heart disease (grade III)
* Any cardiomyopathy including those with preserved left ventricular ejection fraction (LVEF)
* Chronic obstructive pulmonary disease
* Severe bronchial asthma
* Metabolic acidosis at time of randomization
* Renal failure (creatinine \>2.0 mg/dL)
* N-terminal pro B-type natriuretic peptide (NT-proBNP) \>300 ng/L
* Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) which is associated with moderate or severe hepatic impairment (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.0 upper limit of normal (ULN))
* Untreated pheochromocytoma
* Late stage of peripheral arterial disease or Raynaud's syndrome
* Participation in another clinical trial according to AMG or MPG at the time of randomization and the duration of this trial
* Patients who are unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
* Persons who are legally detained in an official institution
* Persons likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of patient's and investigator's knwoledge
* Persons who may dependent on the Sponsor, the Investigator or the trial sites, are not eligible to enter the trial
* Active coronavirus disease 2019 (COVID-19) at time of randomization
18 Years
85 Years
ALL
No
Sponsors
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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Ulf Landmesser
Prof. Dr.
Principal Investigators
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Ulf Landmesser, Prof. Dr.
Role: STUDY_CHAIR
Charité University, Berlin, Germany
Barbara E Stähli, Prof. Dr.
Role: STUDY_CHAIR
Universitätsspital Zürich
Locations
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Kerckhoff-Klinik gGmbH
Bad Nauheim, , Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Charité University Medicine Berlin, Campus Benjamin Franklin
Berlin, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Deutsches Herzzentrum München des Freistaates Bayern - Klinik an der Technischen Universität München
München, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Inselspital, Universitätsspital Bern
Bern, , Switzerland
Universitäres Herzzentrum Zürich, Universitätsspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Roland Klingenberg, PD Dr.
Role: primary
Tanja Rudolph, Prof. Dr.
Role: primary
Ulf Landmesser, Prof. Dr.
Role: primary
Luise Gaede, PD Dr.
Role: primary
Stephan Fichtlscherer, Prof. Dr.
Role: primary
Peter Clemmensen, Prof. Dr.
Role: primary
Manuela Licka, Dr.
Role: primary
Matthias Lutz, PD Dr.
Role: primary
Karsten Lenk, PD Dr.
Role: primary
Tommaso Gori, Prof. Dr.
Role: primary
Ibrahim Akin, Prof. Dr.
Role: primary
Jens Wiebe, PD Dr.
Role: primary
Ong Peter, Prof. Dr.
Role: primary
Lorenz Räber, Prof. Dr.
Role: primary
Barbara Stähli, Prof. Dr.
Role: primary
Other Identifiers
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2020-004717-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EXAMINE-CAD-DZHK22
Identifier Type: -
Identifier Source: org_study_id
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