Heart failure
Conditions
Interventions
Trade Name: BLOPRESS 8 MG
Product Name: BLOPRESS 8 mg
Product Code: Candesartan Cilexetil
Pharmaceutical Form: Tablet
INN or Proposed INN: Candesartan Cilexetil
Concentration unit: mg milligram(s)
Con
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients of at least 18 years of age - Heart failure with systolic dysfunction and LVEF = 40% since at least 4 weeks without any expected deterioration in the next 4 months according to clinical experience - NYHA classification of II or III in a stable condition since at least 3 months - Existing standard HF therapy with an ACE inhibitor alone or together with further preparations in a constant regimen since at least 1 month, in case of beta-blockers since at least 3 months - BNP values at baseline of more than 200 pg/ml - No previous therapy with angiotensin-receptor blockers (ARBs) during the last 4 weeks prior to the study - A woman of childbearing potential must have a negative pregnancy test before study start, routinely use oral or injectable contraceptives or intrauterine devices during the study and plan not to become pregnant during the study - A woman of non-childbearing potential could be included if postmenopausal for at least one year or surgically sterilised or hysterectomised at least three months before study start - Available signed written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Primary diastolic dysfunction (e.g. amyloidosis or cardiomyopathy) - Impaired renal function (serum creatinine > 2.2 mg/dl or > 194 µmol/l) - Known bilateral renal artery stenosis (RAS) or interventional treatment for RAS in the last year - State after kidney transplantation - Serum potassium higher than 5.5 mmol/l - Known disposition to symptomatic hypotension or sSBP 2xULN or Gamma GT > 3xULN) - History of primary hyperaldosteronism, of cancer in the last 5 years (exception: non metastasizing skin cancer) or of another wasting disease with life expectancy of < 2 years - Known hypersensitivity to Candesartan Cilexetil - Concomitant long-term therapy with NSAIDs or Cox-2-inhibitors - Use of other ARBs throughout the entire study period - Any history of life-threatening diseases - Female patients who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the course of BNP (B-type natriuretic peptide) over 4 months of constant therapy and its correlation to other objective HF parameters (e.g. LVEF, NYHA-class, quality of life) in order to generate further efficacy data for the angiotensin II type I receptor blocker Candesartan Cilexetil in the treatment of heart failure when administered in an "added" regimen to standard HF therapy with at least ACE inhibitors. ;Secondary Objective: In addition the following secondary efficacy variables will be analysed: • Mean change from baseline (V1) to V6 for LVEF, NYHA-class, SF-36-score and NT-proBNP • Mean change from V4 to V6 for NYHA-class, BNP and NT-proBNP • Correlations of BNP with LVEF, NYHA classification, SF-36 score and NT-proBNP • Subgroup evaluation regarding beta-blocker therapy (yes/no) and NYHA classification (II / III) • Subgroup evaluation in terms of the different possible dosages of study medication during the 16 weeks of constant therapy (i.e. for 8, 16 or 32 mg Candesartan) ;Primary end point(s): Course of BNP (mean change from baseline (V1) to V6) | — |
Countries
Germany
Outcome results
None listed