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

NCT ID: NCT03066804

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-22
• Study Completion Date: 2019-10-28

Brief 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).

Detailed Description

This study was a 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate sacubitril/valsartan compared to individualized medical therapy on NT proBNP, exercise capacity, symptoms and QoL in patients with heart failure and preserved left ventricular ejection (HFpEF) fraction (LVEF > 40%). Patients were initially stratified into one of three strata according to prior treatment for comorbidities: Angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or no prior renin angiotensin system inhibitors (RASi). Patients in each stratum were randomized in a 1:1 ratio and received either sacubitril/valsartan or comparator (i.e.

enalapril for patients in ACEi strata, valsartan for patients in the ARB strata and placebo for patients in the No RASi strata). There was no designated proportion of patients planned in each stratum; the strata were populated based upon the patient's prior treatment regimen. The study consisted of a screening epoch of up to 2 weeks and a randomized treatment epoch of 24 weeks, which included a 1 to 4 week study drug up-titration epoch followed by a 20 to 23 week maintenance epoch. Uptitration to target doses was recommended to occur within the first four weeks of the study, and was performed by Investigator's discretion based on the patient's clinical status.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sacubitril/valsartan (LCZ696)

All patients who fulfill the inclusion/exclusion criteria will be stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi. Patients in the ACEi strata will receive LCZ696 or enalapril. Patients in the ARB strata will receive LCZ696 or valsartan. Patients in the no RASi strata will receive LCZ696 or matching placebo.

Patients in the ACEi and ARB strata will take two pills twice daily for each dose: one tablet from the LCZ696 pack and one tablet from the comparator pack. Patients in the no RASi strata will take only one tablet twice daily (LCZ696 or matching placebo).

In the LCZ696 arm, patients will receive active LCZ696 in titrated doses from level 1 up to level 3 (50 mg, 100 mg and 200 mg twice daily orally).

Group Type: EXPERIMENTAL

sacubitril/valsartan

Intervention Type: DRUG

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

Placebo to match enalapril

Intervention Type: DRUG

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

Placebo to match valsartan

Intervention Type: DRUG

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

Comparator

Patients randomized to the comparator arm will receive either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum).

Patients in the ACE stratum randomized to comparator, will receive enalapril in titrated doses from level 1 up to level 3 (2.5 mg, 5 mg and 10 mg twice daily).

Patients in the ARB stratum randomized to comparator will receive valsartan in titrated doses from level 1 up to level 3 (40 mg , 80 mg and 160 mg twice daily).

Patients in the no RASi stratum randomized to comparator will receive LCZ696 matching placebo.

Group Type: ACTIVE_COMPARATOR

Enalapril

Intervention Type: DRUG

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

Valsartan

Intervention Type: DRUG

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

Placebo to match sacubitril/valsartan

Intervention Type: DRUG

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

Interventions

sacubitril/valsartan

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

Intervention Type: DRUG

Enalapril

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

Intervention Type: DRUG

Valsartan

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

Intervention Type: DRUG

Placebo to match sacubitril/valsartan

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

Intervention Type: DRUG

Placebo to match enalapril

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

Intervention Type: DRUG

Placebo to match valsartan

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Left ventricular ejection fraction (LVEF) >40% by echo within 6 months prior to study entry or during the screening epoch
• Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
• NYHA class II-IV
• Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
• NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
• KCCQ clinical summary score < 75
• Patients on ACEi or ARB therapy must have a history of HTN

Exclusion Criteria

• Any prior measurement of LVEF ≤ 40%, under stable conditions
• Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
• Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be >40%
• Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.
• Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
• History of hypersensitivity to LCZ696 or its components
• Patients with a known history of angioedema
• Walk distance primarily limited by non-cardiac comorbid conditions at study entry
• Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2.
• Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry.
• Patients with HbA1c > 7.5% not treated for diabetes
• Patients with prior major organ transplant or intent to transplant (ie on transplant list)
• eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
• Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at study entry
• History or presence of any other disease with a life expectancy of < 3 years
• Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Andalusia, Alabama, United States

Novartis Investigative Site

Mobile, Alabama, United States

Novartis Investigative Site

Beverly Hills, California, United States

Novartis Investigative Site

Long Beach, California, United States

Novartis Investigative Site

Santa Ana, California, United States

Novartis Investigative Site

Sylmar, California, United States

Novartis Investigative Site

Aurora, Colorado, United States

Novartis Investigative Site

Stamford, Connecticut, United States

Novartis Investigative Site

Bradenton, Florida, United States

Novartis Investigative Site

Gainesville, Florida, United States

Novartis Investigative Site

Hollywood, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Port Orange, Florida, United States

Novartis Investigative Site

Thomasville, Georgia, United States

Novartis Investigative Site

Arlington Heights, Illinois, United States

Novartis Investigative Site

Alexandria, Louisiana, United States

Novartis Investigative Site

Chalmette, Louisiana, United States

Novartis Investigative Site

Houma, Louisiana, United States

Novartis Investigative Site

Boston, Massachusetts, United States

Novartis Investigative Site

Lincoln, Nebraska, United States

Novartis Investigative Site

Omaha, Nebraska, United States

Novartis Investigative Site

Rochester, New York, United States

Novartis Investigative Site

Marion, Ohio, United States

Novartis Investigative Site

Corvallis, Oregon, United States

Novartis Investigative Site

Abington, Pennsylvania, United States

Novartis Investigative Site

Sioux Falls, South Dakota, United States

Novartis Investigative Site

Jackson, Tennessee, United States

Novartis Investigative Site

Dallas, Texas, United States

Novartis Investigative Site

Lufkin, Texas, United States

Novartis Investigative Site

Tomball, Texas, United States

Novartis Investigative Site

Falls Church, Virginia, United States

Novartis Investigative Site

Seattle, Washington, United States

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

Posadas, Misiones Province, Argentina

Novartis Investigative Site

Salta, Salta Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, San Miguel de Tucuman, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

Formosa, , Argentina

Novartis Investigative Site

San Luis, , Argentina

Novartis Investigative Site

Santa Fe, , Argentina

Novartis Investigative Site

Santa Fe, , Argentina

Novartis Investigative Site

Santa Fe, , Argentina

Novartis Investigative Site

Braunau am Inn, , Austria

Novartis Investigative Site

Graz, , Austria

Novartis Investigative Site

Hall in Tirol, , Austria

Novartis Investigative Site

Linz, , Austria

Novartis Investigative Site

Salzburg, , Austria

Novartis Investigative Site

Genk, , Belgium

Novartis Investigative Site

Ghent, , Belgium

Novartis Investigative Site

Heusden-Zolder, , Belgium

Novartis Investigative Site

Huy, , Belgium

Novartis Investigative Site

Kortrijk, , Belgium

Novartis Investigative Site

Fortaleza, Ceará, Brazil

Novartis Investigative Site

Goiânia, Goiás, Brazil

Novartis Investigative Site

Goiânia, Goiás, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Curitiba, Paraná, Brazil

Novartis Investigative Site

Canoas, Rio Grande do Sul, Brazil

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Novartis Investigative Site

Blumenau, Santa Catarina, Brazil

Novartis Investigative Site

Campinas, São Paulo, Brazil

Novartis Investigative Site

Ribeirão Preto, São Paulo, Brazil

Novartis Investigative Site

São José do Rio Preto, São Paulo, Brazil

Novartis Investigative Site

São José do Rio Preto, São Paulo, Brazil

Novartis Investigative Site

Burgas, , Bulgaria

Novartis Investigative Site

Pazardzhik, , Bulgaria

Novartis Investigative Site

Pernik, , Bulgaria

Novartis Investigative Site

Pleven, , Bulgaria

Novartis Investigative Site

Plovdiv, , Bulgaria

Novartis Investigative Site

Plovdiv, , Bulgaria

Novartis Investigative Site

Shumen, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Veliko Tarnovo, , Bulgaria

Novartis Investigative Site

Moncton, New Brunswick, Canada

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

Oakville, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

St-Georges Beauce, Quebec, Canada

Novartis Investigative Site

Medellín, Antioquia, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Barranquilla, , Colombia

Novartis Investigative Site

Barranquilla, , Colombia

Novartis Investigative Site

Montería, , Colombia

Novartis Investigative Site

San Gil, , Colombia

Novartis Investigative Site

Brandýs nad Labem, Czech Republic, Czechia

Novartis Investigative Site

Brno, Czech Republic, Czechia

Novartis Investigative Site

Český Krumlov, Czech Republic, Czechia

Novartis Investigative Site

Jablonec nad Nisou, Czech Republic, Czechia

Novartis Investigative Site

Kroměříž, Czech Republic, Czechia

Novartis Investigative Site

Liberec, Czech Republic, Czechia

Novartis Investigative Site

Louny, Czech Republic, Czechia

Novartis Investigative Site

Pardubice, Czech Republic, Czechia

Novartis Investigative Site

Pilsen, Czech Republic, Czechia

Novartis Investigative Site

Svitavy, Czech Republic, Czechia

Novartis Investigative Site

Tábor, Czech Republic, Czechia

Novartis Investigative Site

Třebíč, Czech Republic, Czechia

Novartis Investigative Site

Jihlava, CZE, Czechia

Novartis Investigative Site

Policska, CZE, Czechia

Novartis Investigative Site

Kolín, , Czechia

Novartis Investigative Site

Olomouc Lazce, , Czechia

Novartis Investigative Site

Přerov, , Czechia

Novartis Investigative Site

Valašské Meziříčí, , Czechia

Novartis Investigative Site

Copenhagen NV, , Denmark

Novartis Investigative Site

Hvidovre, , Denmark

Novartis Investigative Site

Randers, , Denmark

Novartis Investigative Site

Tallinn, , Estonia

Novartis Investigative Site

Tallinn, , Estonia

Novartis Investigative Site

Tartu, , Estonia

Novartis Investigative Site

Besançon, , France

Novartis Investigative Site

Chambray-lès-Tours, , France

Novartis Investigative Site

Corbeil-Essonnes, , France

Novartis Investigative Site

Le Coudray, , France

Novartis Investigative Site

Le Kremlin-Bicêtre, , France

Novartis Investigative Site

Limoges, , France

Novartis Investigative Site

Marseille, , France

Novartis Investigative Site

Rennes, , France

Novartis Investigative Site

Tourcoing, , France

Novartis Investigative Site

Valenciennes, , France

Novartis Investigative Site

Regensburg, Bavaria, Germany

Novartis Investigative Site

Essen, DEU, Germany

Novartis Investigative Site

Detmold, North Rhine-Westphalia, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Bad Homburg, , Germany

Novartis Investigative Site

Bad Oeynhausen, , Germany

Novartis Investigative Site

Bamberg, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bielefeld, , Germany

Novartis Investigative Site

Brüel, , Germany

Novartis Investigative Site

Buch, , Germany

Novartis Investigative Site

Chemnitz, , Germany

Novartis Investigative Site

Coburg, , Germany

Novartis Investigative Site

Cologne, , Germany

Novartis Investigative Site

Dortmund, , Germany

Novartis Investigative Site

Dortmund, , Germany

Novartis Investigative Site

Dresden, , Germany

Novartis Investigative Site

Dresden, , Germany

Novartis Investigative Site

Dresden, , Germany

Novartis Investigative Site

Elsterwerda, , Germany

Novartis Investigative Site

Erfurt, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Fulda, , Germany

Novartis Investigative Site

Fürth, , Germany

Novartis Investigative Site

Halle, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Haßloch, , Germany

Novartis Investigative Site

Jena, , Germany

Novartis Investigative Site

Kiel, , Germany

Novartis Investigative Site

Koeln-Nippes, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Ludwigshafen, , Germany

Novartis Investigative Site

Ludwigshafen, , Germany

Novartis Investigative Site

Lübeck, , Germany

Novartis Investigative Site

Lüneburg, , Germany

Novartis Investigative Site

Mainz, , Germany

Novartis Investigative Site

Mannheim, , Germany

Novartis Investigative Site

Munich, , Germany

Novartis Investigative Site

Mühldorf, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Neuruppin, , Germany

Novartis Investigative Site

Nienburg, , Germany

Novartis Investigative Site

Nuremberg, , Germany

Novartis Investigative Site

Papenburg, , Germany

Novartis Investigative Site

Potsdam, , Germany

Novartis Investigative Site

Riesa, , Germany

Novartis Investigative Site

Rodgau, , Germany

Novartis Investigative Site

Rostock, , Germany

Novartis Investigative Site

Rotenburg an der Fulda, , Germany

Novartis Investigative Site

Rüsselsheim am Main, , Germany

Novartis Investigative Site

Schwäbisch Hall, , Germany

Novartis Investigative Site

Siegen, , Germany

Novartis Investigative Site

Stadtlohn, , Germany

Novartis Investigative Site

Ulm, , Germany

Novartis Investigative Site

Ulm, , Germany

Novartis Investigative Site

Wallerfing, , Germany

Novartis Investigative Site

Wattenscheid, , Germany

Novartis Investigative Site

Wedel, , Germany

Novartis Investigative Site

Wismar, , Germany

Novartis Investigative Site

Würzburg, , Germany

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Guatemala City, , Guatemala

Novartis Investigative Site

Budapest, HUN, Hungary

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Mosanmagyarovar, , Hungary

Novartis Investigative Site

Szeged, , Hungary

Novartis Investigative Site

Ahmedabad, Gujarat, India

Novartis Investigative Site

Vadodara, Gujarat, India

Novartis Investigative Site

Manipal, Karnataka, India

Novartis Investigative Site

Nagpur, Maharashtra, India

Novartis Investigative Site

Nashik, Maharashtra, India

Novartis Investigative Site

Nashik, Maharashtra, India

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Novartis Investigative Site

Bikaner, Rajasthan, India

Novartis Investigative Site

Lucknow, Uttar Pradesh, India

Novartis Investigative Site

India, , India

Novartis Investigative Site

Ashkelon, , Israel

Novartis Investigative Site

Beersheba, , Israel

Novartis Investigative Site

Hadera, , Israel

Novartis Investigative Site

Haifa, , Israel

Novartis Investigative Site

Petah Tikva, , Israel

Novartis Investigative Site

Rehovot, , Israel

Novartis Investigative Site

Cortona, AR, Italy

Novartis Investigative Site

Bergamo, BG, Italy

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Legnano, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Sesto San Giovanni, MI, Italy

Novartis Investigative Site

Palermo, PA, Italy

Novartis Investigative Site

Rovigo, RO, Italy

Novartis Investigative Site

Sassari, SS, Italy

Novartis Investigative Site

Cona, , Italy

Novartis Investigative Site

San Vito al Tagliamento, , Italy

Novartis Investigative Site

Liepāja, LVA, Latvia

Novartis Investigative Site

Daugavpils, , Latvia

Novartis Investigative Site

Ogre, , Latvia

Novartis Investigative Site

Riga, , Latvia

Novartis Investigative Site

Kaunas, LTU, Lithuania

Novartis Investigative Site

Kaunas, , Lithuania

Novartis Investigative Site

Vilnius, , Lithuania

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Querétaro, , Mexico

Novartis Investigative Site

San Luis Potosí City, , Mexico

Novartis Investigative Site

Almelo, , Netherlands

Novartis Investigative Site

Amsterdam, , Netherlands

Novartis Investigative Site

Deventer, , Netherlands

Novartis Investigative Site

Doetinchem, , Netherlands

Novartis Investigative Site

Gouda, , Netherlands

Novartis Investigative Site

Groningen, , Netherlands

Novartis Investigative Site

Hardenberg, , Netherlands

Novartis Investigative Site

Nijmegen, , Netherlands

Novartis Investigative Site

Stadskanaal, , Netherlands

Novartis Investigative Site

Tilburg, , Netherlands

Novartis Investigative Site

Venlo, , Netherlands

Novartis Investigative Site

Trujillo, La Libertad, Peru

Novartis Investigative Site

Jesus Maria, Lima region, Peru

Novartis Investigative Site

Lima Cercado, Lima region, Peru

Novartis Investigative Site

San Borja, Lima region, Peru

Novartis Investigative Site

San Isidro, Lima region, Peru

Novartis Investigative Site

San Miguel, Lima region, Peru

Novartis Investigative Site

Callao, , Peru

Novartis Investigative Site

Braga, , Portugal

Novartis Investigative Site

Lisbon, , Portugal

Novartis Investigative Site

Lisbon, , Portugal

Novartis Investigative Site

Lisbon, , Portugal

Novartis Investigative Site

Penafiel, , Portugal

Novartis Investigative Site

Porto, , Portugal

Novartis Investigative Site

Viana do Castelo, , Portugal

Novartis Investigative Site

Vila Real, , Portugal

Novartis Investigative Site

Bucharest, District 4, Romania

Novartis Investigative Site

Timișoara, Timiș County, Romania

Novartis Investigative Site

Timișoara, Timiș County, Romania

Novartis Investigative Site

Bacau, , Romania

Novartis Investigative Site

Baia Mare, , Romania

Novartis Investigative Site

Bucharest, , Romania

Novartis Investigative Site

Bucharest, , Romania

Novartis Investigative Site

Bucharest, , Romania

Novartis Investigative Site

Craiova, , Romania

Novartis Investigative Site

Craiova, , Romania

Novartis Investigative Site

Piteşti, , Romania

Novartis Investigative Site

Târgovişte, , Romania

Novartis Investigative Site

Târgu Mureş, , Romania

Novartis Investigative Site

Târgu Mureş, , Romania

Novartis Investigative Site

Timișoara, , Romania

Novartis Investigative Site

Gatchina, , Russia

Novartis Investigative Site

Ivanovo, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Moscow, , Russia

Novartis Investigative Site

Nizhny Novgorod, , Russia

Novartis Investigative Site

Perm, , Russia

Novartis Investigative Site

Rostov-on-Don, , Russia

Novartis Investigative Site

Rostov-on-Don, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Saratov, , Russia

Novartis Investigative Site

Tyumen, , Russia

Novartis Investigative Site

Yaroslavl, , Russia

Novartis Investigative Site

Yekaterinburg, , Russia

Novartis Investigative Site

Yekaterinburg, , Russia

Novartis Investigative Site

Belgrade, , Serbia

Novartis Investigative Site

Kamenitz, , Serbia

Novartis Investigative Site

Kragujevac, , Serbia

Novartis Investigative Site

Niš, , Serbia

Novartis Investigative Site

Niška Banja, , Serbia

Novartis Investigative Site

Námestovo, Slovak Republic, Slovakia

Novartis Investigative Site

Prešov, Slovak Republic, Slovakia

Novartis Investigative Site

Bratislava, SVK, Slovakia

Novartis Investigative Site

Handlová, SVK, Slovakia

Novartis Investigative Site

Bardejov, , Slovakia

Novartis Investigative Site

Bardejov, , Slovakia

Novartis Investigative Site

Bratislava, , Slovakia

Novartis Investigative Site

Bratislava, , Slovakia

Novartis Investigative Site

Dolný Kubín, , Slovakia

Novartis Investigative Site

Košice, , Slovakia

Novartis Investigative Site

Lučenec, , Slovakia

Novartis Investigative Site

Moldava nad Bodvou, , Slovakia

Novartis Investigative Site

Nitra, , Slovakia

Novartis Investigative Site

Nové Zámky, , Slovakia

Novartis Investigative Site

Nové Zámky, , Slovakia

Novartis Investigative Site

Považská Bystrica, , Slovakia

Novartis Investigative Site

Prešov, , Slovakia

Novartis Investigative Site

Snina, , Slovakia

Novartis Investigative Site

Svidník, , Slovakia

Novartis Investigative Site

Trnava, , Slovakia

Novartis Investigative Site

Córdoba, Andalusia, Spain

Novartis Investigative Site

Huelva, Andalusia, Spain

Novartis Investigative Site

Málaga, Andalusia, Spain

Novartis Investigative Site

Puerto Real, Cadiz, Spain

Novartis Investigative Site

Villamartín, Cadiz, Spain

Novartis Investigative Site

Lleida, Catalonia, Spain

Novartis Investigative Site

A Coruña, Galicia, Spain

Novartis Investigative Site

San Sebastián de los Reyes, Madrid, Spain

Novartis Investigative Site

El Palmar, Murcia, Spain

Novartis Investigative Site

Manises, Valencia, Spain

Novartis Investigative Site

Torrevieja (Alicante), Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Alicante, , Spain

Novartis Investigative Site

Las Palmas de Gran Canarias, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Seville, , Spain

Novartis Investigative Site

Valencia, , Spain

Novartis Investigative Site

Muang, Muang, Thailand

Novartis Investigative Site

Khon Kaen, THA, Thailand

Novartis Investigative Site

Bangkok, , Thailand

Novartis Investigative Site

Bangkok, , Thailand

Novartis Investigative Site

Bangkok, , Thailand

Novartis Investigative Site

Ubon Ratchathani, , Thailand

Novartis Investigative Site

Eskişehir, Meselik, Turkey (Türkiye)

Novartis Investigative Site

Adana, , Turkey (Türkiye)

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Novartis Investigative Site

Antalya, , Turkey (Türkiye)

Novartis Investigative Site

Aydin, , Turkey (Türkiye)

Novartis Investigative Site

Bursa, , Turkey (Türkiye)

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Novartis Investigative Site

Kocaeli, , Turkey (Türkiye)

Novartis Investigative Site

Mersin, , Turkey (Türkiye)

Novartis Investigative Site

Sivas, , Turkey (Türkiye)

Novartis Investigative Site

Talas / Kayseri, , Turkey (Türkiye)

Novartis Investigative Site

High Wycombe, Buckinghamshire, United Kingdom

Novartis Investigative Site

Stockton-on-Tees, Cleveland, United Kingdom

Novartis Investigative Site

Chesterfield, Derbyshire, United Kingdom

Novartis Investigative Site

Craigavon, Northern Ireland, United Kingdom

Novartis Investigative Site

Wansford, Peterborough, United Kingdom

Novartis Investigative Site

Addlestone, Surrey, United Kingdom

Novartis Investigative Site

Sunderland, Tyne and Wear, United Kingdom

Novartis Investigative Site

Leeds, , United Kingdom

Novartis Investigative Site

York, , United Kingdom

Countries

United States; Argentina; Austria; Belgium; Brazil; Bulgaria; Canada; Colombia; Czechia; Denmark; Estonia; France; Germany; Guatemala; Hungary; India; Israel; Italy; Latvia; Lithuania; Mexico; Netherlands; Peru; Portugal; Romania; Russia; Serbia; Slovakia; Spain; Thailand; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34783839 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=740

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

2016-003410-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLCZ696D2302

Identifier Type: -

Identifier Source: org_study_id