E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertrophic cardiomyopathy |
Hypertrofisk kardiomyopati |
|
E.1.1.1 | Medical condition in easily understood language |
Hereditary thickening of the heart muscle (hypertrophic cardiomyopathy) |
Arvelig fortykkelse af hjertemuskulaturen (hypertrofisk kardiomyopati) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020876 |
E.1.2 | Term | Hypertrophic obstructive cardiomyopathy |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To find out whether treatment with losartan reduces left ventricular mass in patients with hypertrophic cardiomyopathy. |
At undersøge hvorvidt losartan reducerer venstre ventrikels masse hos patienter med hypertrofisk kardiomyopati. |
|
E.2.2 | Secondary objectives of the trial |
To find out whether treatment with losartan
- reduces myocardial fibrosis
- increases systolic and diastolic funktion
- increases work capacity
- decreases riskfactors for sudden cardiac death
- decreases arrythmias
- reduces symptoms of heart failure |
At undersøge hvorvidt losartan
- reducerer fibrose i myokardiet
- forbedrer systolisk og diastolisk funktion
- forbedrer arbejdskapaciteten
- reducerer risikofaktorer for pludselig hjertedød
- reducerer antallet af arytmier
- reducerer symptom på hjertesvigt
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Known hypertophic cardiomyopathy
- > 18 years
- Sinus rhythm |
- Kendt hypertofisk kardiomyopati
- > 18 år
- Sinusrytme |
|
E.4 | Principal exclusion criteria |
- Ejection fraction < 50 %
- Treatment with inhibitor of the renin angiotensin system within 3 months
- Pregnancy or lactation
- Renal insufficiency
- Liver insufficiency
- Hypotension
- Not sufficiently treated hypertesnion
- Earlier experinced angioneurotic oedema when treated with inhibitor of the renin angiotensin system
- Treatment with Lithium
- Expected non-compliance |
- Ejection fraction < 50 %
- Behanling med et præparat der inhiberer renin angiotensin systemet indenfor de sidste tre måneder
- Graviditet eller amning
- Nyreinsufficiens
- Nedsat leverfunktion
- Hypotension
- Utilstrækkeligt behandlet hypertension
- Tidligere angioneutorisk ødem ved behanling med inhibitor af renin angiotensin systemet
- Behandling med lithium
- Forventet dårlig compliance
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Left ventricular mass |
Venstre ventrikel masse |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Thickness of septum
- Thckness of left ventricles postrior wall
- Fibrosis of left ventricular wall
- Gradient in Left ventricular outflow tract
- Systolic function of left ventricle
- Diastolic function of left ventricle
- Left atrial volume
- Arythmias
- Work load
- Blood pressure response
- Symptoms of heart failure
- Hypertrophy in ECG
- NT-pro-BNP
- Risk factors of sudden cardiac death
- Selfassessed health and life quality
- Tolerability |
- Tykkelse af septum
- Tykkelse af venstre ventrikels bagvæg
- Fibrose af venstre ventrikels væg
- Gradient i Left ventricular outflow tract
- Systolisk funktion af venstre ventrikel
- Diastolisk funktion af venstre ventrikel
- Volumen af venstre atrium
- Arytmier
- Arbejdskapacitet
- Blodtryksrespons ved arbejd
- Symptomer på hjertesvigt
- Hypertrofi i EKG
- NT-pro-BNP
- Risikofaktorer for pludselig død
- Selvvurderet helbred og livskvalitet
- Tolerabilitet
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject. |
Sidste forsøgspersons sidste besøg. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |