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

Primary Purpose

Chronic Heart Failure

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LCZ696

Valsartan

Placebo

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic heart failure, preserved ejection fraction, cardiovascular disease, NT-proBNP, biomarkers, Heart failure with preserved left-ventricular ejection, fraction

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCZ696

Valsartan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Evaluation of NT-proBNP was performed by a central laboratory. Change from baseline in NT-proBNP was presented as a ratio where the ratio was calculated as the NT-proBNP value at 12 weeks over the NT-proBNP value at baseline. A ratio < 1 indicates improvement.

Secondary Outcome Measures

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

Evaluation of NT-proBNP and BNP was performed by a central laboratory. Change from baseline in NT-proBNP and in BNP was presented as a ratio where the ratio for NT-proBNP was calculated as the NT-proBNP value at 36 weeks over the NT-proBNP value at baseline, and the ratio for BNP was calculated as the BNP value at 36 weeks over the BNP value at baseline. A ratio < 1 indicates improvement.

Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)

Evaluation of cGMP was performed by a central laboratory. Change from baseline in cGMP was presented as a ratio where the ratio was calculated as the cGMP value at 36 weeks over the cGMP value at baseline. A ratio < 1 indicates improvement.

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

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

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

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Change From Baseline in Echocardiography Parameters: Left Ventricular Mass

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

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

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

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

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement.

Change in Echocardiography Parameters: Isovolumic Relaxation Time

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

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

The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement.

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

The clinical composite assessment is defined as follows: Improved = a) participant improved (markedly or moderately) in the global assessment of disease activity with no worsening of NYHA functional class and no major adverse cardiovascular event or b) participant improved in NYHA functional class with no worsening (markedly or moderately) in the global assessment of disease activity and no major adverse cardiovascular event. Worsened = participant worsened (markedly or moderately) in the global assessment of disease activity or in NYHA functional class or experienced a major adverse cardiovascular event. Unchanged = participant does not meet the definition for improved or worsened.

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

The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases.

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.

Change From Baseline in Serum Creatinine

Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement.

Change From Baseline in Albumin/Creatinine Ratio

Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement.

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

A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.

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)

Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.

Full Information

NCT ID

NCT00887588

First Posted

April 22, 2009

Last Updated

August 12, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00887588

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

Chronic heart failure, preserved ejection fraction, cardiovascular disease, NT-proBNP, biomarkers, Heart failure with preserved left-ventricular ejection, fraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

307 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCZ696

Arm Type

Experimental

Arm Description

Arm Title

Valsartan

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LCZ696

Intervention Description

50 mg, 100 mg and 200 mg tablets

Intervention Type

Drug

Intervention Name(s)

Valsartan

Intervention Description

40 mg, 80 mg and 160 mg tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

matching placebo to LCZ696 and Valsartan

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

baseline, 36 weeks

Title

Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)

Description

Time Frame

baseline, 36 weeks

Title

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

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

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

Change From Baseline in Echocardiography Parameters: Left Ventricular Mass

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

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

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

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

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement.

Time Frame

Baseline, 36 weeks

Title

Change in Echocardiography Parameters: Isovolumic Relaxation Time

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.

Time Frame

Baseline, 36 weeks

Title

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

Description

Time Frame

baseline, 36 weeks

Title

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

Description

Time Frame

36 weeks

Title

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

Description

Time Frame

baseline, 36 weeks

Title

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Description

eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.

Time Frame

baseline, 36 weeks

Title

Change From Baseline in Serum Creatinine

Description

Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement.

Time Frame

baseline, 36 weeks

Title

Change From Baseline in Albumin/Creatinine Ratio

Description

Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement.

Time Frame

baseline, 36 weeks

Title

Description

Time Frame

baseline, 36 weeks

Title

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

Description

Time Frame

baseline, 36 weeks

Title

Change From Baseline in Arterial Stiffness Parameters: Heart Rate

Description

Time Frame

baseline, 36 weeks

Title

Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity

Description

Time Frame

baseline, 36 weeks

Title

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

Description

Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.

Time Frame

baseline, 36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60657

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Novartis Investigative Site

City

Grand Island

State/Province

Nebraska

ZIP/Postal Code

68803

Country

United States

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Novartis Investigative Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74133

Country

United States

Facility Name

Novartis Investigative Site

City

Hillsboro

State/Province

Oregon

ZIP/Postal Code

97123

Country

United States

Facility Name

Novartis Investigative Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1408INH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

State/Province

Buenos Aires

ZIP/Postal Code

C1119ACN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ramos Mejia

State/Province

Buenos Aires

ZIP/Postal Code

B1704ETD

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Martin

State/Province

Buenos Aires

ZIP/Postal Code

B1650CSQ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S200CVD

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000EBR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000EPU

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000EVQ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Corrientes

ZIP/Postal Code

W3400

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FWO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Goiania

State/Province

ZIP/Postal Code

74605-050

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Jose do Rio Preto

State/Province

ZIP/Postal Code

15015-750

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6Z 4N5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Novartis Investigative Site

City

Göttingen

ZIP/Postal Code

D-37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Andhra Pradesh, INDIA

ZIP/Postal Code

500034

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500012

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

Novartis Investigative Site

City

Mangalore

State/Province

Karnataka

ZIP/Postal Code

575002

Country

India

Facility Name

Novartis Investigative Site

City

Manipal

State/Province

Karnataka

ZIP/Postal Code

576104

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 022

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

44000033

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440012

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302001

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302004

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

ZIP/Postal Code

500 063

Country

India

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24128

Country

Italy

Facility Name

Novartis Investigative Site

City

Cosenza

State/Province

ZIP/Postal Code

87100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Casorate Primo

State/Province

ZIP/Postal Code

27022

Country

Italy

Facility Name

Novartis Investigative Site

City

Sarzana

State/Province

ZIP/Postal Code

19038

Country

Italy

Facility Name

Novartis Investigative Site

City

San Daniele Del Friuli

State/Province

ZIP/Postal Code

33038

Country

Italy

Facility Name

Novartis Investigative Site

City

Somma Lombardo

State/Province

ZIP/Postal Code

21019

Country

Italy

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Delft

ZIP/Postal Code

NL 2625 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Ede

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Goes

ZIP/Postal Code

4462 RA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Heerenveen

ZIP/Postal Code

8441 PW

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Heerlen

ZIP/Postal Code

6419 PC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hengelo

ZIP/Postal Code

7555 DL

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Piotrkow Trybunalski

ZIP/Postal Code

97-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Sieradz

ZIP/Postal Code

98-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa/Anin

ZIP/Postal Code

04-761

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-981

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Jud. Dolj

ZIP/Postal Code

200147

Country

Romania

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Jud.Dolj

ZIP/Postal Code

200235

Country

Romania

Facility Name

Novartis Investigative Site

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Novartis Investigative Site

City

Pitesti

ZIP/Postal Code

110114

Country

Romania

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

S.-Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169609

Country

Singapore

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03004

Country

Spain

Facility Name

Novartis Investigative Site

City

A Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Caracas

State/Province

Distrito Capital

ZIP/Postal Code

1010

Country

Venezuela

Facility Name

Novartis Investigative Site

City

Maracaibo

State/Province

Estado Zulia

ZIP/Postal Code

4011

Country

Venezuela

12. IPD Sharing Statement

Citations:

PubMed Identifier

22932717

Citation

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.

Results Reference

background

PubMed Identifier

30354399

Citation

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.

Results Reference

derived

PubMed Identifier

26754625

Citation

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.

Results Reference

derived

PubMed Identifier

26280447

Citation

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.

Results Reference

derived

PubMed Identifier

25277997

Citation

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.

Results Reference

derived

PubMed Identifier

25138249

Citation

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.

Results Reference

derived

PubMed Identifier

24184245

Citation

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. Erratum In: J Am Coll Cardiol. 2014 Jul 22;64(3):335.

Results Reference

derived

Learn more about this trial

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

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

Chronic Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial