Hypertrophic obstructive cardiomyopathy MedDRA version: 20.0 Level: LLT Classification code 10020876 Term: Hypertrophic obstructive cardiomyopathy System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Metoprololsuccinat
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: metoprololsuccinat
Other descriptive name: METOPROLOL SUCCINATE
Concentration unit: mg milligram(s)
Co
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent - Symptomatic patients, who fits the criteria for HCM ( wall thickness = 15 mm in one or more myocardial segments that is not explained by loading conditions.) - LVOTG > 30 mmHg at rest and/or >50 mmHg at Valsalva’s maneuver or exercise - = NYHA II Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: - Age < 18 years - Know allergi to trial medication - Contraindications to beta-blocker treatment - Contraindications to Magnetic resonance scan including the contrast agent gadolineum - Female patients who are pregnant (positive Plasma-HCG), nursing, or of childbearing potential while not practicing effective chemical contraceptive methods (i.e. oral, implanted, injectable or transdermal contraceptive hormones; intrauterine device) - Pacemaker - Treatment with Cordarone - Atrial fibrillation/flutter at the time of examination - Bradycardia < 49 beats/min - Systolic blood pressure < 100 mmHg - Trifasicular block - Previous TASH (transcoronary ablation of septum hypertrophy) or myectomy - Current abuse of alcohol and drugs - Significant comorbidity or issue that makes the patient unsuitable fpr participation, judged by the investigator - Patients who cannot give valid consent (e.g. mental illness or dementia) - Patients who do not understand danish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We want to quantify the effect of metoprololsuccinat on myocardial function, hemodynamics and symptoms in patients with hypertrophic obstructive cardiomyopathy.;Secondary Objective: not applicable;Primary end point(s): The primary endpoint is the reduction in Pulmonary Capillary Wedge Pressure (PCWP). ;Timepoint(s) of evaluation of this end point: The randomization codes will be unblinded when 27 patients with HOCM have finished full trial participation, after this the endpoint will be evaluated. Final endpoint evaluation is estimatede to 18-24 months after the first patient have been enrolled. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is the increase in oxygen consumption, coronary flow reserve and mechanical efficiency and the reduction in interventriculare pressure gradients during exercise, NT-proBNP, heart failure symptoms and improvement of lifequality.;Timepoint(s) of evaluation of this end point: The randomization codes will be unblinded when 27 patients with HOCM have finished full trial participation, after this the endpoints will be evaluated. Final endpoint evaluation is estimatede to 18-24 months after the first patient have been enrolled. | — |
Countries
Denmark
Contacts
Public ContactSteen Hvitfeldt Poulsen
Aarhus University Hospital
Outcome results
None listed