Symptomatic heart failure with diastolic dysfunction in diabetic and hypertensive patients MedDRA version: 9.1 Level: LLT Classification code 10019279 Term: Heart failure MedDRA version: 9.1 Level: LLT Classification code 10052337 Term: Diastolic dysfunction
Conditions
Interventions
Trade Name: Blopress 8mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Candesartan cilexetil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmac
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patient of at least 45 years of age - Diabetes mellitus type 2 - insulin dependent or orally treated or managed by diet for at least 3 months - Normotension or controlled hypertension with sSBP 220 >1 45 Pseudonormalisation (II) 0,75-1, 5 150-220 1,5 =150 40 MIE/ml and estrogen =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following criteria must not be met to enrol a single patient into the study: - 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 > 5.5 mmol/l or HbA1C > 9.5 % - Cor pulmonale or primary pulmonary disease with dyspnea at rest - Known disposition to episodes of symptomatic hypotension or sSBP 100 bpm as confirmed by ECG-recordings - Known clinically relevant rhythm disorders (e.g., tachyarrhythmias, salves of supraventricular or ventricular extrasystoles or atrial fibrillation without ventricular rate control) or symptoms suggesting a significant rhythm disorder (e.g., recurrent syncopes) - Primary valvular diseases and/or restrictive or obstructive cardiomyopathy - Existing ventricular assist devices - Relevant liver diseases (cholestasis or ALAT/ASAT > 2xULN or ?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 - Need for maintenance therapy with NSAIDs or Cox-2-inhibitors - Use of other ARBs throughout the entire study period - Any history of life-threatening diseases - History of drug addiction and/or an extensive use of alcohol - Female patients who are pregnant or breast feeding - Sexually active women of childbearing potential not consistently and correctly practicing highly effective birth control with a low failure rate (less than 1% / year) such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner - Psychological and/or emotional problems, which render the informed consent invalid or limit the ability of the patient to comply with the study requirements - Patient is an employee or at least in dependence of the investigator and/or the sponsor or of another institution directly involved in the study or other trials under the investigator's direction - Participation in another clinical investigation within 30 days prior to enrolment or for the course of the present study (incl. studies for compassionate use or experimental medical devices)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable will be the mean change from baseline (V1) compared to the final study visit (V6) of the objective primary study endpoint NT-proBNP during the planned 24-week period of study treatment. The change will be calculated as the NT-proBNP value at baseline (V1; day 0) minus the NT-proBNP value at the final visit (V6; day 168±8). The natural logarithmic transformation will be applied to the NT-proBNP values because of their expected skewed distribution. Patients who terminated treatment before end of week 24 will be considered with their individual last value under study medication (last-observation-carried-forward method; LOCF). In case of missing baseline values for NT-proBNP, results from the screening visit (V0) will be used. Absolute values and changes from baseline will be presented for NT-proBNP values after 24 weeks of treatment (and at each scheduled time point) using descriptive summary statistics. Moreover percentage changes from baseline will be displayed. Presentation of summary descriptive results will also include display of the untransformed NT-proBNP values. The confirmatory inferential statistical analysis of the primary study endpoint will be performed with the same test procedure as used for the sample size calculation, i.e. the one-sided t-test for two independent samples. The t-test will be calculated with the parameter estimates of an analysis of covariance (ANCOVA) using the primary target parameter as dependent variable, the treatment group as fixed factor and the baseline NT-proBNP value as covariate. In addition, exploratory ANCOVA will be done using baseline eGFR and Cystatin C values as covariates. Exploration of possible heterogeneity of treatment effects across centers will be provided in a descriptive manner only, e.g. by graphical display of the results of individual centers. The confirmatory analysis of the primary efficacy variable will be done for the full analysis set. Additional effic | — |
Countries
Germany
Outcome results
None listed