Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients (TITRATION)

Novartis

Status and phase: Completed; Phase 2

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01922089

2013-001835-33 (EudraCT Number)

CLCZ696B2228

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

Enrollment: 498 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

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 inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

498 participants in 2 patient groups

LCZ696 Condensed

Experimental group

Description:

Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks

Treatment:

Drug: LCZ696

LCZ696 Conservative

Experimental group

Description:

Up-titration to LCZ696 200 mg bid over 6 weeks

Treatment:

Drug: LCZ696