A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

Summary

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Timeline

Start

2017-08-22

Primary completion

2019-10-28

Completion

2019-10-28

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry p <0.0001; Geometric Mean Ratio 0.8362 (95% CI 0.7987 to 0.8754) reads as mixed primary results NCT03066804 ↗

registry p = 0.4164; Mean Difference (Net) -2.4985 (95% CI -8.5267 to 3.52297) reads as mixed primary results NCT03066804 ↗

release “PARAGON-HF trial, which show overall treatment effect, despite narrow miss on statistical significance” reads as missed primary endpoint novartis.com ↗

Publications

• Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enalapril	Other / unclassified	2.5 mg	Oral
Subject	Enalapril	Other / unclassified	5 mg	Oral
Subject	Enalapril	Other / unclassified	10 mg	Oral
Subject	Valsartan	Unknown	40 mg	Oral
Subject	Valsartan	Unknown	80 mg	Oral
Subject	Valsartan	Unknown	160 mg	Oral
Subject	sacubitril/valsartan	Unknown	50 mg	Oral
Subject	sacubitril/valsartan	Unknown	100 mg	Oral
Subject	sacubitril/valsartan	Unknown	200 mg	Oral

Indications