None listed
Conditions
Interventions
Trade Name: EnalHexal®, 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: ENALAPRIL
CAS Number: 75847733
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Phar
Sponsors
Friedrich- Alexander- Universität Erlangen Nürnberg
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male patients with DMD (confirmed by genetic analysis or muscle biopsy) • aged 10 – 14 years • Normal left ventricular function (fraction shortening = 30%) • Normal renal function (GFR > 30 ml/min/1,73 m2) • Informed Consent of both parents, assent of patient Are the trial subjects under 18? yes Number of subjects for this age range: 55 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Dilated left ventricle (size > 97. Percentile) or Left Ventricular Dysfunction (fraction shortening <30%) • contraindications for ACE-Inhibitors/Beta-Blocker • previous therapy with ACE-Inhibitors, AT II Antagonists, Beta-Blockers • Other medical reasons which render participation not reasonable for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of prophylactic anticongestive therapy: time from randomisation to left ventricular dysfunction, defined as left-ventricular shortening fraction <28%(6 monthly control visits);Secondary Objective: - Comparison of safety and tolerability - Comparison of quality of life (Kindl questionnaire12-16) - Comparison of diagnostics: Tissue Doppler vs 2D Echocardiography - Comparison of total survival in both arms - Comparison of pathophysiological changes in neuromuscular regulation (neurohumeral parameters like pro- BNP, Angiotensin II, Noradrenalin) - Comparison of drop of heart frequency rate and heart frequency variability (24h ECG, Tissue Doppler) ;Primary end point(s): efficacy of prophylactic anticongestive therapy, time from randomisation to left ventricular dysfunction,defined as left-ventricular shortening fraction < 28% (6 monthly control visits);Timepoint(s) of evaluation of this end point: from baseline R4 until study end | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): comparison of safety and tolerability comparison of quality of life (Kindl) comparison of diagnostics tissue doppler vs 2 D Echo comparison of pro-BNP, Angiotensin II, Noradrenalin;Timepoint(s) of evaluation of this end point: change of LVSF from baseline | — |
Countries
Germany
Contacts
Public ContactLKP
Universitätsklinikum Erlangen, Kinderkardiologie
Outcome results
None listed