E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
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 |
The primary objective is to evaluate if 9 months of heart failure treatment guided by clinical symptoms, signs and NT-proBNP values is more effective to reduce the combination of cardiovascular (CV) death, CV hospitalisation and heart failure symptoms, than treatment guided by clinical symptoms and signs alone, in patients with chronic heart failure. |
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E.2.2 | Secondary objectives of the trial |
To study if this treatment is more effective to reduce CV death, decrease the number of days in hospital for CV reasons and reduce heart failure symptoms, separately. To study the change in NT-proBNP values over time in all patients, related to different medications used, correlated to NYHA class and correlated to the KCCQ questionnaire. To study the change in health-related quality of life. To study the level of titration and intensified treatment according to the Swedish guidelines as outlined by the Swedish Medical Product Agency (MPA, Läkemedelsverket 2006). To study the change in vital signs, laboratory values, heart failure status, incidence of SAE and discontinuations due to AEs. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Provision of informed consent. 2. Female or male, aged 18 years and over 3. Diagnosis of heart failure with previously verified left ventricular systolic dysfunction, stated as at least mildly impaired and/or ejection fraction (EF) < 50%. 4. NYHA class II-IV 5. Plasma NT-proBNP: males >800 ng/L, females >1000 ng/L |
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E.4 | Principal exclusion criteria |
1. Planned CV hospitalisation (eg cardiac surgery) within the study period. 2. Stroke, acute myocardial infarction or open heart surgery within the last 3 months before enrolment. 3. Mitral stenosis, aortic stenosis of clinical significance. 4. Patients already receiving optimal heart failure treatment according to the national guidelines. 5 Pregnancy or lactation. 6. Severe medical condition, other than disease under investigation, with life expectancy less than 9 months. 7. Severe reduction of kidney function, serum-creatinine >265 umol/L. 8. Suspected poor capability to follow instructions of the study 9. Previous participation in the present study 10. Participation in a clinical study during the last 30 days. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable is a composite endpoint of days alive, days out of hospital and the symptom score subset (questions 3,5,7,9) of the KCCQ. Only CV deaths and days spent in hospital for CV reasons contribute to the endpoint. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
|
End of study is defined in the protocol as date of database lock, which is the time point after which no patient will be exposed to study related activities. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |