Candesartan added Treatment for Optimisation of Heart Failure (HF) Therapy - Effects on BNP and other HF associated Parameters.An open, non-controlled and multicentre trial

• Conditions: Heart failure

• Registration Number: EUCTR2004-003962-14-DE
• Lead Sponsor: Takeda Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-15
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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 < 95 mmHg at baseline
- Myocardial infarction, open heart surgery or cerebral event (stroke/TIA) in the last
3 months
- Hemodynamically relevant stenosis of the aortic and/or mitral valve
- Relevant liver diseases (cholestasis or ALAT/ASAT > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified