Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

Heart Failure With Preserved Ejection Fraction Clinical Trial

— PARAGON-HF  

Official title:

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 (PARAGON-HF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920711
• Other study ID #: CLCZ696D2301
• Secondary ID: 2013-001747-31
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2014
• Est. completion date: June 7, 2019

Study information

• Verified date: September 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Description:

This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication.

For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4822
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Left ventricular ejection fraction (LVEF) =45% by echo during screening epoch or within 6 months prior to study entry.

• Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.

• Current symptom(s) of HF (NYHA class II-IV)

• Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.

• Elevated NT-proBNP

Exclusion Criteria:

• Any prior measurement of LVEF < 40%.

• Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.

• Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF =45%.

• Current acute decompensated HF requiring therapy.

• Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.

• Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.

• Systolic blood pressure (SBP) = 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry.

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Drug:
• LCZ696
LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.
• Valsartan
Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba
Argentina	Novartis Investigative Site	Caba	Capital Federal
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad de Salta	Provincia De Salta
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Posadas	Misiones
Argentina	Novartis Investigative Site	Quilmes	Buenos Aires
Argentina	Novartis Investigative Site	Ramos Mejia	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	San Luis
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Tucuman	San Miguel De Tucuman
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Bundoora	Victoria
Australia	Novartis Investigative Site	Epping	Victoria
Australia	Novartis Investigative Site	Geelong	Victoria
Australia	Novartis Investigative Site	Southport	Queensland
Austria	Novartis Investigative Site	Braunau
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Großgmain
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Austria	Novartis Investigative Site	Linz
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Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Antwerpen
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Belgium	Novartis Investigative Site	Genk
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Czechia	Novartis Investigative Site	Uherske Hradiste
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Czechia	Novartis Investigative Site	Znojmo	Czech Republic
Denmark	Novartis Investigative Site	Esbjerg
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Germany	Novartis Investigative Site	Aachen
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Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Meißen
Germany	Novartis Investigative Site	Memmingen
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Germany	Novartis Investigative Site	Muehldorf Am Inn
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Munich
Germany	Novartis Investigative Site	Nienburg
Germany	Novartis Investigative Site	Northeim
Germany	Novartis Investigative Site	Oschatz
Germany	Novartis Investigative Site	Papenburg
Germany	Novartis Investigative Site	Reinfeld
Germany	Novartis Investigative Site	Riesa
Germany	Novartis Investigative Site	Rodgau
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wermsdorf
Germany	Novartis Investigative Site	Weyhe
Germany	Novartis Investigative Site	Witten
Germany	Novartis Investigative Site	Wuerzburg
Greece	Novartis Investigative Site	Athens	Attica
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Ioannina	GR
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Cegled
Hungary	Novartis Investigative Site	Kistarcsa
Hungary	Novartis Investigative Site	Mako
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Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Pécs
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekesfehervar
Hungary	Novartis Investigative Site	Zalaegerszeg	Zala
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Bikaner	Rajasthan
India	Novartis Investigative Site	Chandigarh	Haryana
India	Novartis Investigative Site	Chennai	Tamil NADU
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Guntur	Andhra Pradesh
India	Novartis Investigative Site	Gurgaon	Haryana
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India	Novartis Investigative Site	Ludhiana	Punjab
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India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Surat	Gujarat
India	Novartis Investigative Site	Vishakhapatnam	Andhra Pradesh
Israel	Novartis Investigative Site	Hadera
Israel	Novartis Investigative Site	Hadera
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Israel	Novartis Investigative Site	Ramat Gan
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Italy	Novartis Investigative Site	Aosta	AO
Italy	Novartis Investigative Site	Ariccia	RM
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bologna	BO
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Italy	Novartis Investigative Site	Cona	FE
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Italy	Novartis Investigative Site	Messina	ME
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Italy	Novartis Investigative Site	Milano
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Italy	Novartis Investigative Site	Perugia	PG
Italy	Novartis Investigative Site	Pozzilli	IS
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
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Japan	Novartis Investigative Site	Amagasaki city	Hyogo
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Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
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Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
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Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
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United States	Novartis Investigative Site	Winston-Salem	North Carolina
United States	Novartis Investigative Site	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Guatemala,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.	The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association [NYHA] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction [LVEF] =45%). The treatment arm with the lower rate of events will be deemed as having a successful response.	Total follow up time (up to 57 months)
Secondary	Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)	The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations.	Baseline, 8 months
Secondary	Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class	Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.	Baseline, 8 months
Secondary	Participants With First Occurrence of a Composite Renal Endpoint	Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or =50% decline in eGFR relative to baseline, using Cox's proportional hazards model.	Randomization to total follow-up time (up to 57 months)
Secondary	All-cause Mortality	Analysis for all-cause mortality using Cox's proportional hazards model.	Randomization to total follow up time (up to 57 months)