EXAMINE-CAD-DZHK22 is a prospective, randomized, double-blind, placebo-controlled, crossover trial investigating the efficacy of beta blocker (bisoprolol) and calcium channel blocker (diltiazem) therapy in symptomatic patients with non-obstructed coronary arteries according to coronary physiological testing results.
Patients presenting with recurrent angina but non-obstructed coronary arteries are increasingly recognized and have a high morbidity and symptomatic burden. These patients are often misdiagnosed and discharged without further investigation or treatment. Current European Society of Cardiology (ESC) guidelines for the management of patients with chronic coronary syndromes recommend beta blockers or calcium channel blockers, depending on the presence of abnormal vasodilatation or abnormal vasoconstriction. Scientific evidence to support this recommendation, however, is scarce and no randomized clinical trial of this differential therapy has been performed in these patients. The aim of the EXAMINE-CAD-DZHK22 trial is therefore to compare for the first time the efficacy of beta blocker (bisoprolol) and calcium channel blocker (diltiazem) therapy in reducing angina symptoms in symptomatic patients with non-obstructed coronary arteries according to coronary physiology testing results. This study is the first to investigate whether coronary physiology testing can guide therapeutic management of these patients depending on whether abnormalities of vasodilatation or vasoconstriction are present. The EXAMINE-CAD-DZHK22 trial will thus fill an important knowledge and evidence gap in the treatment of these highly symptomatic patients, and has the potential to pave the way for future large-scale clinical trials in symptomatic patients with non-obstructed coronary arteries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
beta-adrenergic receptor blocker
calcium channel blocker
Placebo
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
NOT_YET_RECRUITINGHerz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
NOT_YET_RECRUITINGCharité University Medicine Berlin, Campus Benjamin Franklin
Berlin, Germany
RECRUITINGUniversitätsklinikum Erlangen
Erlangen, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Frankfurt
Frankfurt, Germany
NOT_YET_RECRUITINGUniversitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Heidelberg
Heidelberg, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Leipzig
Leipzig, Germany
NOT_YET_RECRUITINGUniversitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
NOT_YET_RECRUITING...and 5 more locations
Change in angina symptom severity as measured by the Seattle Angina Questionnaire (SAQ) summary score from each period specific baseline to the end of this period (week 4)
Assessment of angina symptom severity as measured by the SAQ summary score resulting from the SAQ physical limitation scale, SAQ angina frequency scale, and SAQ quality of life scale. The score ranges from 0 to 100, with the lower the score, the higher the symptom severity and limitations.
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
SAQ angina stability scale
Individual SAQ domain to evaluate the disease-specific health status with quantification of patients' symptoms of angina. The score ranges from 0 to 100, with the lower the score, the higher the symptom severity and limitations.
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
SAQ angina frequency scale
Individual SAQ domain to evaluate the disease-specific health status with quantification of patients' symptoms of angina. The score ranges from 0 to 100, with the lower the score, the higher the symptom severity and limitations.
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
SAQ treatment satisfaction scale
Individual SAQ domain to evaluate the disease-specific treatment satisfaction. The score ranges from 0 to 100, with the higher the score, the higher the treatment satisfaction.
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
SAQ physical limitation scale
Individual SAQ domain to evaluate the disease-specific health status with quantification of patients' symptoms of angina and the extent to which their angina affects their functioning. The score ranges from 0 to 100, with the lower the score, the higher the symptom severity and limitations.
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
SAQ quality of life
Individual SAQ domain to evaluate the disease-specific health status with the extent to which their angina affects their quality of life. The score ranges from 0 to 100, with the higher the score, the higher the quality of life.
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Duke Activity Status Index (DASI)
Assessment of functional capacity of patients with cardiovascular disease
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Rose dyspnea scale
Assessment of patients' dyspnea level with common activities. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea.
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Angina diary (Angina episodes per week)
Assessment of angina frequency
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Angina diary (nitroglycerin use per week))
Assessment of need for nitroglycerine
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Quality of Life (Short Form 36 health survey questionnaire)
Evaluation of health-related quality of life
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Psychological symptoms as assessed by Patient Health Questionnaire (PHQ-9)
Assessment of symptoms for depression in patients with physical illness or physical complaints
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Psychological symptoms as assessed by the Hospital Anxiety Depression Scale (HADS))
Assessment of symptoms for depression and anxiety in patients with physical illness or physical complaints
Time frame: from each period specific baseline to the end of this period, i.e. baseline and 4 weeks; 6 weeks and 10 weeks; 12 weeks and 16 weeks
Functional capacity as assessed by bicycle exercise testing
Assessment of functional capacity in bicycle exercise testing (i.e. maximum load capacity in watt)
Time frame: from baseline (visit 1) to the end of each treatment period (4 weeks, 10 weeks, 16 weeks)
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