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LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Heart Failure

Intervention: LCZ696 (Drug); Valsartan (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Novartis, Study Director, Affiliation: Novartis

Summary

The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection fraction.

Clinical Details

Official title: A 36-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

Secondary outcome:

Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP)

Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)

Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension

Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume

Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction

Change From Baseline in Echocardiography Parameters: Left Ventricular Mass

Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index

Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index

Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus

Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio

Change in Echocardiography Parameters: Isovolumic Relaxation Time

Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity

Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and Individual Domain Summary Scores

Percentage of Participants With Clinical Composite Assessment of Improved, Unchanged or Worsened

Percentage of Participants With New York Heart Association (NYHA) Class I, II, II or IV

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Change From Baseline in Serum Creatinine

Change From Baseline in Albumin/Creatinine Ratio

Change From Baseline in Arterial Stiffness Parameters: Brachial Systolic Blood Pressure (SBP), Brachial Diastolic Blood Pressure (DBP), Central Augmentation Pressure, Central Pressure at T1-DP, Central SBP, Central DBP, Central Mean Pressure

Change From Baseline in Arterial Stiffness Parameters: Heart Rate Correct Cen Aug/Pulse Ht

Change From Baseline in Arterial Stiffness Parameters: Heart Rate

Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity

Change From Baseline in Sitting SBP, Sitting DBP and Sitting Pulse Pressure (PP)

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with documented stable chronic heart failure (NYHA II-IV):

- 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 with a prior LVEF reading <45%, at any time.

- 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.

- Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Cordoba X5000EPU, Argentina

Novartis Investigative Site, Cordoba X5000EVQ, Argentina

Novartis Investigative Site, Corrientes W3400, Argentina

Novartis Investigative Site, Santa Fe S3000FWO, Argentina

Novartis Investigative Site, Santa Fe 3000, Argentina

Novartis Investigative Site, Göttingen D-37075, Germany

Novartis Investigative Site, Hyderabad 500 063, India

Novartis Investigative Site, Amsterdam 1105 AZ, Netherlands

Novartis Investigative Site, Delft NL 2625 AD, Netherlands

Novartis Investigative Site, Ede 6716 RP, Netherlands

Novartis Investigative Site, Goes 4462 RA, Netherlands

Novartis Investigative Site, Groningen 9713 GZ, Netherlands

Novartis Investigative Site, Heerenveen 8441 PW, Netherlands

Novartis Investigative Site, Heerlen 6419 PC, Netherlands

Novartis Investigative Site, Hengelo 7555 DL, Netherlands

Novartis Investigative Site, Piotrkow Trybunalski 97-300, Poland

Novartis Investigative Site, Sieradz 98-200, Poland

Novartis Investigative Site, Warszawa/Anin 04-761, Poland

Novartis Investigative Site, Wroclaw 50-981, Poland

Novartis Investigative Site, Wroclaw 51-124, Poland

Novartis Investigative Site, Baia Mare 430031, Romania

Novartis Investigative Site, Pitesti 110114, Romania

Novartis Investigative Site, Moscow 121552, Russian Federation

Novartis Investigative Site, Moscow 117292, Russian Federation

Novartis Investigative Site, S.-Petersburg 196247, Russian Federation

Novartis Investigative Site, Saint-Petersburg 194044, Russian Federation

Novartis Investigative Site, Saint-Petersburg 197341, Russian Federation

Novartis Investigative Site, Singapore 119074, Singapore

Novartis Investigative Site, Singapore 169609, Singapore

Novartis Investigative Site, Madrid 28034, Spain

Novartis Investigative Site, Madrid 28046, Spain

Novartis Investigative Site, Sevilla, Andalucia 41009, Spain

Novartis Investigative Site, Hyderabad, Andhra Pradesh 500012, India

Novartis Investigative Site, Hyderabad, Andhra Pradesh, INDIA 500034, India

Novartis Investigative Site, Little Rock, Arkansas 72205, United States

Novartis Investigative Site, Bergamo, BG 24128, Italy

Novartis Investigative Site, Hospitalet de Llobregat, Barcelona 08907, Spain

Novartis Investigative Site, Caba, Buenos Aires C1408INH, Argentina

Novartis Investigative Site, Ciudad Autonoma de Bs As, Buenos Aires C1119ACN, Argentina

Novartis Investigative Site, Ramos Mejia, Buenos Aires B1704ETD, Argentina

Novartis Investigative Site, San Martin, Buenos Aires B1650CSQ, Argentina

Novartis Investigative Site, Cosenza, CS 87100, Italy

Novartis Investigative Site, Alicante, Comunidad Valenciana 03004, Spain

Novartis Investigative Site, New Delhi, Delhi 110060, India

Novartis Investigative Site, Caracas, Distrito Capital 1010, Venezuela

Novartis Investigative Site, Maracaibo, Estado Zulia 4011, Venezuela

Novartis Investigative Site, Goiania, GO 74605-050, Brazil

Novartis Investigative Site, A Coruna, Galicia 15006, Spain

Novartis Investigative Site, Santiago de Compostela, Galicia 15706, Spain

Novartis Investigative Site, Chicago, Illinois 60657, United States

Novartis Investigative Site, Craiova, Jud. Dolj 200147, Romania

Novartis Investigative Site, Craiova, Jud.Dolj 200235, Romania

Novartis Investigative Site, Mangalore, Karnataka 575002, India

Novartis Investigative Site, Manipal, Karnataka 576104, India

Novartis Investigative Site, Mumbai, Maharashtra 400 022, India

Novartis Investigative Site, Nagpur, Maharashtra 44000033, India

Novartis Investigative Site, Nagpur, Maharashtra 440012, India

Novartis Investigative Site, Detroit, Michigan 48201, United States

Novartis Investigative Site, Grand Island, Nebraska 68803, United States

Novartis Investigative Site, Lincoln, Nebraska 68506, United States

Novartis Investigative Site, Oklahoma City, Oklahoma 73120, United States

Novartis Investigative Site, Tulsa, Oklahoma 74133, United States

Novartis Investigative Site, Brampton, Ontario L6Z 4N5, Canada

Novartis Investigative Site, Hillsboro, Oregon 97123, United States

Novartis Investigative Site, Pisa, PI 56124, Italy

Novartis Investigative Site, Casorate Primo, PV 27022, Italy

Novartis Investigative Site, Wyomissing, Pennsylvania 19610, United States

Novartis Investigative Site, Montreal, Quebec H3A 1A1, Canada

Novartis Investigative Site, Montreal, Quebec H3G 1A4, Canada

Novartis Investigative Site, Porto Alegre, RS 90610-000, Brazil

Novartis Investigative Site, Jaipur, Rajasthan 302004, India

Novartis Investigative Site, Jaipur, Rajasthan 302001, India

Novartis Investigative Site, Sao Jose do Rio Preto, SP 15150-210, Brazil

Novartis Investigative Site, São Paulo, SP 05403-000, Brazil

Novartis Investigative Site, Sarzana, SP 19038, Italy

Novartis Investigative Site, Rosario, Santa Fe S200CVD, Argentina

Novartis Investigative Site, Nashville, Tennessee 37203, United States

Novartis Investigative Site, Houston, Texas 77025, United States

Novartis Investigative Site, San Miguel de Tucuman, Tucuman T4000EBR, Argentina

Novartis Investigative Site, San Daniele Del Friuli, UD 33038, Italy

Novartis Investigative Site, Somma Lombardo, VA 21019, Italy

Additional Information

Related publications:

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.

Starting date: November 2009
Last updated: July 16, 2015

Page last updated: August 23, 2015

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