A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction (CLCZ696D2301)

A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction (CLCZ696D2301) - CLCZ696D2301 (PARAGON)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47866

Enrollment

100

Registered

2014-08-12

Start date

2014-12-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Interventions

Treatment with LCZ696 or valsartan.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - * 55 years of age, male or female. - Left ventricular ejection fraction (LVEF) *45% by echo during the screening epoch, or within 6 months prior to Visit 1. - Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF *30 days prior to Visit 1. - Current symptom(s) of HF (NYHA Class II-IV) at Visit 1. - Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram. - A HF hospitalization within 9 months prior to Visit 1 and/or an elevated NT-proBNP at Visit 1. - See protocol for details and more inclusion criteria.

Exclusion criteria

Exclusion criteria: - Any prior echocardiographic measurement of LVEF 40 kg/m2. - Hyper- or hypotension. - See protocol for details and more exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Cumulative number of primary composite events of cardiovascular (CV) death and total (first and recurrent) HF hospitalizations.	—

Secondary

Measure	Time frame
- Change in KCCQ clinical summary score from baseline to Month 8. - Change from baseline to Month 8 in New York Heart Association (NYHA) functional class. - Time to composite renal endpoint. - Time to all-cause mortality.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)