LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
NCT ID: NCT00887588
Last Updated: 2015-08-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
307 participants
INTERVENTIONAL
2009-11-30
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
NCT02884206
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
NCT02970669
Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers
NCT01353508
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
NCT01681576
Differential Vascular and Endocrine Effects of Valsartan/Sacubitril in Heart Failure With Reduced Ejection Fraction
NCT03168568
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LCZ696
During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
LCZ696
50 mg, 100 mg and 200 mg tablets
Placebo
matching placebo to LCZ696 and Valsartan
Valsartan
During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
Valsartan
40 mg, 80 mg and 160 mg tablets
Placebo
matching placebo to LCZ696 and Valsartan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LCZ696
50 mg, 100 mg and 200 mg tablets
Valsartan
40 mg, 80 mg and 160 mg tablets
Placebo
matching placebo to LCZ696 and Valsartan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* LVEF ≥ 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography)
* the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction.
* Plasma NT-proBNP \> 500 pg/ml at Visit 1.
* Patients with documented stable chronic heart failure (NYHA II-IV).
* Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit 1.
* Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted).
* Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2).
* Patients with at least one of the following symptoms at the time of screening (Visit 1):
* Dyspnea on exertion
* Orthopnea
* Paroxysmal nocturnal dyspnea
* Peripheral edema
* Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
* Patients with a potassium ≤5.2 mmol/l at Visit 1.
Exclusion Criteria
* Patients who require treatment with both an ACE inhibitor and an ARB.
* Isolated right heart failure due to pulmonary disease.
* Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity.
* Presence of hemodynamically significant mitral and /or aortic valve disease.
* Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
* Presence of hypertrophic obstructive cardiomyopathy.
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
Grand Island, Nebraska, United States
Novartis Investigative Site
Lincoln, Nebraska, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Tulsa, Oklahoma, United States
Novartis Investigative Site
Hillsboro, Oregon, United States
Novartis Investigative Site
Wyomissing, Pennsylvania, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina
Novartis Investigative Site
Ramos Mejía, Buenos Aires, Argentina
Novartis Investigative Site
San Martín, Buenos Aires, Argentina
Novartis Investigative Site
Corrientes, Corrientes Province, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Santa Fe, Santa Fe Province, Argentina
Novartis Investigative Site
Santa Fe, Santa Fe Province, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, Argentina
Novartis Investigative Site
Goiânia, Goiás, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São José do Rio Preto, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Brampton, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Göttingen, , Germany
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, India
Novartis Investigative Site
Mangalore, Karnataka, India
Novartis Investigative Site
Manipal, Karnataka, India
Novartis Investigative Site
Mumbai, Maharashtra, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
Nagpur, Maharashtra, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Hyderabad, , India
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Cosenza, CS, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Casorate Primo, PV, Italy
Novartis Investigative Site
Sarzana, SP, Italy
Novartis Investigative Site
San Daniele del Friuli, UD, Italy
Novartis Investigative Site
Somma Lombardo, VA, Italy
Novartis Investigative Site
Ede, Netherlands, Netherlands
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Delft, , Netherlands
Novartis Investigative Site
Goes, , Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Heerenveen, , Netherlands
Novartis Investigative Site
Heerlen, , Netherlands
Novartis Investigative Site
Hengelo, , Netherlands
Novartis Investigative Site
Warszawa/Anin, Poland, Poland
Novartis Investigative Site
Piotrkow Trybunalski, , Poland
Novartis Investigative Site
Sieradz, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Craiova, Jud. Dolj, Romania
Novartis Investigative Site
Craiova, Jud.Dolj, Romania
Novartis Investigative Site
Baia Mare, , Romania
Novartis Investigative Site
Piteşti, , Romania
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
S.-Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
A Coruña, Galicia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Alicante, Valencia, Spain
Novartis Investigative Site
Caracas, Distrito Federal, Venezuela
Novartis Investigative Site
Maracaibo, Zulia, Venezuela
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Solomon SD, Zile M, Pieske B, Voors A, Shah A, Kraigher-Krainer E, Shi V, Bransford T, Takeuchi M, Gong J, Lefkowitz M, Packer M, McMurray JJ; Prospective comparison of ARNI with ARB on Management Of heart failUre with preserved ejectioN fracTion (PARAMOUNT) Investigators. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet. 2012 Oct 20;380(9851):1387-95. doi: 10.1016/S0140-6736(12)61227-6. Epub 2012 Aug 26.
Myhre PL, Liu Y, Kulac IJ, Claggett BL, Prescott MF, Felker GM, Butler J, Pina IL, Rouleau JL, Zile MR, McMurray JJV, Ward JH, Solomon SD, Januzzi JL. Changes in mid-regional pro-adrenomedullin during treatment with sacubitril/valsartan. Eur J Heart Fail. 2023 Aug;25(8):1396-1405. doi: 10.1002/ejhf.2957. Epub 2023 Jul 11.
Biering-Sorensen T, Lassen MCH, Shah A, Claggett B, Zile M, Pieske B, Pieske-Kraigher E, Voors A, Shi V, Lefkowitz M, Packer M, McMurray JJV, Solomon SD; PARAMOUNT Investigators. The Effect of Sacubitril/Valsartan on Left Ventricular Myocardial Deformation in Heart Failure with Preserved Ejection Fraction (PARAMOUNT trial). J Card Fail. 2023 Jun;29(6):968-973. doi: 10.1016/j.cardfail.2023.03.019. Epub 2023 Apr 7.
Januzzi JL Jr, Packer M, Claggett B, Liu J, Shah AM, Zile MR, Pieske B, Voors A, Gandhi PU, Prescott MF, Shi V, Lefkowitz MP, McMurray JJV, Solomon SD. IGFBP7 (Insulin-Like Growth Factor-Binding Protein-7) and Neprilysin Inhibition in Patients With Heart Failure. Circ Heart Fail. 2018 Oct;11(10):e005133. doi: 10.1161/CIRCHEARTFAILURE.118.005133.
Zile MR, Jhund PS, Baicu CF, Claggett BL, Pieske B, Voors AA, Prescott MF, Shi V, Lefkowitz M, McMurray JJ, Solomon SD; Prospective Comparison of ARNI With ARB on Management of Heart Failure With Preserved Ejection Fraction (PARAMOUNT) Investigators. Plasma Biomarkers Reflecting Profibrotic Processes in Heart Failure With a Preserved Ejection Fraction: Data From the Prospective Comparison of ARNI With ARB on Management of Heart Failure With Preserved Ejection Fraction Study. Circ Heart Fail. 2016 Jan;9(1):e002551. doi: 10.1161/CIRCHEARTFAILURE.115.002551.
Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.
Jhund PS, Claggett BL, Voors AA, Zile MR, Packer M, Pieske BM, Kraigher-Krainer E, Shah AM, Prescott MF, Shi V, Lefkowitz M, McMurray JJ, Solomon SD; PARAMOUNT Investigators. Elevation in high-sensitivity troponin T in heart failure and preserved ejection fraction and influence of treatment with the angiotensin receptor neprilysin inhibitor LCZ696. Circ Heart Fail. 2014 Nov;7(6):953-9. doi: 10.1161/CIRCHEARTFAILURE.114.001427. Epub 2014 Oct 2.
Santos AB, Kraigher-Krainer E, Gupta DK, Claggett B, Zile MR, Pieske B, Voors AA, Lefkowitz M, Bransford T, Shi V, Packer M, McMurray JJ, Shah AM, Solomon SD; PARAMOUNT Investigators. Impaired left atrial function in heart failure with preserved ejection fraction. Eur J Heart Fail. 2014 Oct;16(10):1096-103. doi: 10.1002/ejhf.147. Epub 2014 Aug 19.
Kraigher-Krainer E, Shah AM, Gupta DK, Santos A, Claggett B, Pieske B, Zile MR, Voors AA, Lefkowitz MP, Packer M, McMurray JJ, Solomon SD; PARAMOUNT Investigators. Impaired systolic function by strain imaging in heart failure with preserved ejection fraction. J Am Coll Cardiol. 2014 Feb 11;63(5):447-56. doi: 10.1016/j.jacc.2013.09.052. Epub 2013 Oct 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-010208-27
Identifier Type: -
Identifier Source: secondary_id
CLCZ696B2214
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.