Efficacy of Candesartan on Brain Natriuretic Peptide Levels in Subjects With Chronic Heart Failure (CANDHEART)
|Heart Failure||Drug: Candesartan and standard chronic heart disease therapy Drug: Standard chronic heart disease therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects Of Candesartan Cilexetil vs Standard Therapy on Serum Levels of Brain Natriuretic Peptide in Patients Suffering From Chronic Heart Failure With Depressed and Preserved Systolic Function|
- Change from baseline in Brain Natriuretic Peptide [ Time Frame: Week 12 or Final Visit. ]
- Change from baseline in Brain Natriuretic Peptide [ Time Frame: Week 48 or Final Visit. ]
- Change from baseline in Aldosterone, Pentraxin-3 and C-Reactive Protein [ Time Frame: Week 48 or Final Visit. ]
- Change from baseline of New York Heart Association class [ Time Frame: Week 48 or Final Visit. ]
- Change from baseline of Left Ventricular Ejection Fraction, Left Ventricular Internal Diastolic Diameter, E wave peak velocity/A wave peak velocity, deceleration time of E wave, atrial dimensions, blood pressure and heart rate [ Time Frame: Week 48 or Final Visit. ]
- Persistence of active treatment and discontinuation rate [ Time Frame: Week 48 or Final Visit. ]
- Quality of life as measured by Kansas City Cardiomyopathy Questionnaire [ Time Frame: Week 48 or Final Visit. ]
|Study Start Date:||December 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Experimental: Candesartan QD||
Drug: Candesartan and standard chronic heart disease therapy
Candesartan 4mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for two weeks; then Candesartan increased up to 32mg, tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.
|Active Comparator: Standard chronic heart disease therapy||
Drug: Standard chronic heart disease therapy
Candesartan placebo-matching tablets, orally, once daily and stable dose therapy for chronic heart disease for up to 48 weeks.
Chronic heart failure is a significant and increasing cause of morbidity and mortality, accounting for a current yearly prevalence of 5 million and a 5-year survival near 50% in the US. In addition, chronic heart failure is still the fourth cause of hospitalization in the US and in Western countries, and it is the leading cause of hospitalization in patients aged over 65.
Newer pharmacological agents and non pharmacological therapeutic tools have been increasingly introduced to improve the outcomes in patients with chronic heart failure. In the past two decades, several large randomized controlled clinical trials have revolutionized the management and prognosis of patients with chronic heart failure. The recommended drug treatment for decreasing mortality and morbidity in chronic heart failure is based on angiotensin converting enzyme-inhibitors, beta-blockers and aldosterone antagonists (limited to most severe patients), as detailed in the latest European Society of Cardiology guidelines. The use of digitalis and diuretics still has a role.
Orally active angiotensin II type I receptor blockers represent a new class of agents that offer an alternative method of the renin-angiotensin system blockade. Their effects on hemodynamics, neuroendocrine activity and exercise tolerance in patients with chronic heart failure can be considered as similar to that exhibited by angiotensin converting enzyme -inhibitors, but it still remains to be fully elucidated whether angiotensin II type I receptor blockers can offer advantage in efficacy, other than in safety, compared to angiotensin converting enzyme -inhibitors.
Brain Natriuretic Peptide is strongly related to the severity and to the increase of cardiovascular events in patients with chronic heart failure. Recent data show that angiotensin II receptor blockers can reduce the levels of Brain Natriuretic Peptide, though no data is available in patients with preserved left ventricular systolic function.
Candesartan is a selective angiotensin II type I receptor blocker, and this study will evaluate the effects of the maximum tolerated dose of Candesartan added to ongoing standard therapy while measuring changes in brain natriuretic peptide biomarker used in the assessment of chronic heart failure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843154
|Study Director:||Medical Director Director||Takeda Italia Farmaceutici SpA|