Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy (TEMPO II)
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- STATUS
- Recruiting
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- End date
- Jun 1, 2025
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- participants needed
- 140
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- sponsor
- Morten Steen Kvistholm Jensen
Summary
Aim: To compare treatment effects of Bisoprolol and Verapamil in 140 patients with non-obstructive hypertrophic cardiomyopathy. The overall clinical purpose is to reduce the symptomatic burden and arrhythmic complications.
Background: Hypertrophic cardiomyopathy (HCM) is characterized by hypertrophy of the left ventricular wall and a hypercontracted state of the sarcomeres. This narrows the left ventricular cavity, but though the left ejection fraction is increased the stroke volume and the cardiac output cannot be fully compensated. The disease manifestiations can be mild or develop into severe functional limitations and devasting complications at early age. Dyspnea, chest pain, palpitations and syncope are the most common symptoms, and patients are at risk of supraventricular and ventricular arrhythmias. Arrhythmias and sudden cardiac deaths may precede heart failue symptoms. Patients with symptomatic HCM are treated initially with beta blockers and calcium channel blockers. However, there is limited evidence supporting the effectiveness of this guideline-recommended treatment in HCM.
Methods: The study is a multicenter, double-blinded, randomized, placebo-controlled cross-over trial. Patients are randomized in to three 35-days treatment periods with Bisprolol, Verapamil and Placebo. Each treatment period includes a 7-days up titration period, a 21-days target dose period and a 7-days down titration period. Between treatment periods 1-30 days treatment pause is allowed. End point will be evaluated at day 21 +/- 4 days. Patients will be evaluated by cardiopulmonary exercise test, echocardiography, 7 day Holter-monitoring, biomarkers and the Kansas City Cardiomyopathy Questionnaire (KCCQ). A subgroup of patients will also be evaluated with cardiac magnetic resonance imaging.
Hypotheses: Three equal independent primary effect parameters will be analyzed between treatment with Bisoprolol and Verapamil:
- The incidence of non-sustained ventricular tachycardia (NSVT) is different between treatment in non-obstructive HCM patients.
- The left ventricular outflow tract (LVOT) time velocity integral (VTI) is different between treatment in non-obstructive HCM patients.
- The maximal oxygen consumption (VO2 max) is different between treatments in non-obstructive HCM patients.
Details
| Condition | Cardiomyopathies, Cardiomyopathy, Hypertrophic, Hypertrophic Cardiomyopathy, Hypertrophy, Non-obstructive Hypertrophic Cardiomyopathy, Cardiovascular Diseases, Heart Diseases, Physiological Effects of Drugs, Pathological Conditions, Anatomical, Arrhythmia, Arrhythmias, Cardiac, Non-Sustained VT, Ventricular Tachycardia, Myocardial Dysfunction, Left Ventricular Hypertrophy |
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| Treatment | Placebo, Verapamil, Bisoprolol |
| Clinical Study Identifier | NCT05569382 |
| Sponsor | Morten Steen Kvistholm Jensen |
| Last Modified on | 22 October 2022 |
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