Comparison of two ways of LCZ696 titration in heart failure patients

• Conditions: Chronic heart failure; MedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001835-33-FI
• Lead Sponsor: ovartis Pharma services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-28
• Last Update Posted: 18 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Age = 18 years.
Chronic Heart Failure with New York Heart Association class II-IV.
Left ventricularejection fraction = 35%.
Patients must be treated with beta-blockers.
Other protocol-defined inclusion criteria may apply.
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

Potassium > 5.2 mmol/l.
Estimated glomerular filtration rate < 30 ml/min/1.73 m2.
Systolic blood pressure <100 mmHg or > 180 mmHg.
History of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers.
Other protocol-defined exclusion criteria may apply.

Study & Design

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