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Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction (EVALUATE-HF)

Primary Purpose

Heart Failure and Reduced Ejection Fraction

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

LCZ696 (sacubitril/valsartan)

Enalapril

Placebo of Enalapril

Placebo of LCZ696

About this trial

This is an interventional treatment trial for Heart Failure and Reduced Ejection Fraction focused on measuring Heart Failure, Reduced Ejection Fraction, Central Aortic Stiffness, Vascular, Echocardiogram, Aortic Stiffness

Eligibility Criteria

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

Inclusion Criteria:

History of HTN and one of the following at BOTH screening and pre-randomization:
1. SBP >105 mm Hg on antihypertensive medication.
2. SBP >/= 140 mm Hg and NOT on antihypertensive medication.
NYHA class I-III heart failure and with reduced ejection fraction </= 40%, as determined by any local measurement made within the past 12 months using echocardiography, MUGA, CT scanning, MRI, ventricular angiography or single-photon emission computed tomography (SPECT), provided no subsequent measurement above 40%. Patients who have had an intervening medical event (e.g. myocardial infarction) or procedure (e.g. revascularization, cardiac resynchronization), must have a reassessment of EF ≥ 3 months following the event to ensure that eligibility criteria are still met.
On stable doses of treatment with guideline-directed therapy, other than ACEis and ARBs prior to randomization.
1. If the patient is currently taking an ACEi, a 36-hour washout is required prior to randomization (Visit 2).
2. If the patient is currently taking an ARB, they must discontinue the ARB before initiation of study treatment however washout is not required.
On an optimal medical regiment of diuretics and background medications to effectively treat co-morbidities such as HTN, DM, and coronary artery disease.

Key Exclusion Criteria:

History of hypersensitivity to any of the study drigs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEis, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
Previous history of intolerance to sacubitril and valsartan, ACEi or ARB standard of care doses despite appropriate and gradual up-titration.
History of angioedema, drug-related or otherwise.
Requirement of treatment with both ACE inhibitor and ARB.
Current or prior treatment with sacubitril and valsartan.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCZ696 (sacubitril/valsartan)

Enalapril

Arm Description

minimum dose: 24/26mg, BID, oral, tablet maximum dose: 97/103mg, BID, oral, tablet All patients will begin on Dose Level 1 (24/26mg) and will be titrated every two weeks to target Dose level 3 (97/103mg). LCZ696 tablets will be provided for the 12-week open label extension.

minimum dose: 2.5mg, BID, oral, tablet maximum dose: 10 mg, BID, oral tablet All patients will begin on Dose Level 1 (2.5mg) and will be titrated every two weeks to target Dose level 3 (10mg).

Outcomes

Primary Outcome Measures

Change From Baseline in Aortic Characteristic Impedance at Week 12

Aortic characteristic impedance, Zc, is the ratio of the change in pressure (dP)produced by a given change in flow (dQ) in early systole, i.e., Zc = dP/dQ. Zc is related directly to aortic wall stiffness and inversely to lumen area.

Secondary Outcome Measures

Pearson Correlation Coefficient Between Change From Baseline in Aortic Characteristic Impedance and Biomarker Levels: B-type Natriuretic Peptide (BNP) During Both Trough and 4 Hours Post-dose at Week 4

Pearson correlation coefficients between changes from baseline in aortic characteristic impedance (dyne x sec/cm5) and biomarker levels such as BNP (pg/ML) during both trough and 4 hours post-dose at Week 4

Pearson Correlation Coefficient Between Change From Baseline in Aortic Characteristic Impedance and Biomarker Levels: cGMP/U-creatinine During Both Trough and 4 Hours Post-dose at Week 4

Pearson correlation coefficient between changes from baseline in aortic characteristic impedance (dyne x sec/cm5) and biomarker levels such as U-cGMP/U-creatinine ratio (nmol/mmol) during both trough and 4 hours post-dose at Week 4

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

Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)

Change From Baseline in Echocardiographic Measure: Global Longitudinal Strain

Parameter measured by echocardiography.

Change From Baseline in Echocardiographic Measure: Left Atrial Volume Index (LAVi)

Parameter measured by echocardiography

Change From Baseline in Echocardiographic Measure: Mitral Annular E' Velocity (Doppler Tissue Imaging)

Parameter measured by echocardiography

Change From Basekine in Echocardiographic Measure: Mitral E/E'

Parameter measured by echocardiography

Change From Baseline in Echocardiographic Measure: Left Ventricular Ejection Fraction (LVEF)

Parameter measured by echocardiography

Change From Baseline in Echocardiographic Measure: Ventricular-vascular Coupling (Ea/Ees)

Parameter measured by echocardiography

Change From Baseline in Echocardiographic Measure: Left Ventricular End Systolic Volume Index (LVESVi)

Parameter measured by echocardiography

Change From Baseline in Echocardiographic Measure: Left Ventricular End Diastolic Volume Index (LVEDVi)

Parameter measured by echocardiography

Full Information

NCT ID

NCT02874794

First Posted

August 5, 2016

Last Updated

December 9, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02874794

Brief Title

Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction

Acronym

EVALUATE-HF

Official Title

A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active-controlled, Forced-titration, 12-week Comparison of Combined Angiotensin-neprilysin Inhibition With Sacubitril and Valsartan Versus Enalapril on Changes in Central Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

August 17, 2016 (Actual)

Primary Completion Date

December 13, 2018 (Actual)

Study Completion Date

January 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.

6. Conditions and Keywords

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

Heart Failure and Reduced Ejection Fraction

Keywords

Heart Failure, Reduced Ejection Fraction, Central Aortic Stiffness, Vascular, Echocardiogram, Aortic Stiffness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

465 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCZ696 (sacubitril/valsartan)

Arm Type

Experimental

Arm Description

Arm Title

Enalapril

Arm Type

Active Comparator

Arm Description

minimum dose: 2.5mg, BID, oral, tablet maximum dose: 10 mg, BID, oral tablet All patients will begin on Dose Level 1 (2.5mg) and will be titrated every two weeks to target Dose level 3 (10mg).

Intervention Type

Drug

Intervention Name(s)

LCZ696 (sacubitril/valsartan)

Other Intervention Name(s)

LCZ696

Intervention Description

24/26mg, 49/51mg and 97/103mg oral, tablets.

Intervention Type

Drug

Intervention Name(s)

Enalapril

Intervention Description

2.5mg, 5mg, and 10mg, oral, tablets

Intervention Type

Drug

Intervention Name(s)

Placebo of Enalapril

Intervention Description

matching placebo (2.5mg, 5mg and 10mg) oral, tablets

Intervention Type

Drug

Intervention Name(s)

Placebo of LCZ696

Intervention Description

matching placebo (24/26mg, 49/51mg and 97/103mg) oral, tablets

Primary Outcome Measure Information:

Title

Change From Baseline in Aortic Characteristic Impedance at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Description

Time Frame

Pre-dose and 4 hours post dose at week 4

Title

Pearson Correlation Coefficient Between Change From Baseline in Aortic Characteristic Impedance and Biomarker Levels: cGMP/U-creatinine During Both Trough and 4 Hours Post-dose at Week 4

Description

Time Frame

pre-dose and 4 hours post dose at week 4

Title

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

Description

Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)

Time Frame

Baseline, Week 12

Title

Change From Baseline in Echocardiographic Measure: Global Longitudinal Strain

Description

Parameter measured by echocardiography.

Time Frame

Baseline, Week 12

Title

Change From Baseline in Echocardiographic Measure: Left Atrial Volume Index (LAVi)

Description

Parameter measured by echocardiography

Time Frame

Baseline, Week 12

Title

Change From Baseline in Echocardiographic Measure: Mitral Annular E' Velocity (Doppler Tissue Imaging)

Description

Parameter measured by echocardiography

Time Frame

Baseline, Week 12

Title

Change From Basekine in Echocardiographic Measure: Mitral E/E'

Description

Parameter measured by echocardiography

Time Frame

Baseline, Week 12

Title

Change From Baseline in Echocardiographic Measure: Left Ventricular Ejection Fraction (LVEF)

Description

Parameter measured by echocardiography

Time Frame

Baseline, Week 12

Title

Change From Baseline in Echocardiographic Measure: Ventricular-vascular Coupling (Ea/Ees)

Description

Parameter measured by echocardiography

Time Frame

Baseline, Week 12

Title

Change From Baseline in Echocardiographic Measure: Left Ventricular End Systolic Volume Index (LVESVi)

Description

Parameter measured by echocardiography

Time Frame

Baseline, Week 12

Title

Change From Baseline in Echocardiographic Measure: Left Ventricular End Diastolic Volume Index (LVEDVi)

Description

Parameter measured by echocardiography

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of HTN and one of the following at BOTH screening and pre-randomization: SBP >105 mm Hg on antihypertensive medication. SBP >/= 140 mm Hg and NOT on antihypertensive medication. NYHA class I-III heart failure and with reduced ejection fraction </= 40%, as determined by any local measurement made within the past 12 months using echocardiography, MUGA, CT scanning, MRI, ventricular angiography or single-photon emission computed tomography (SPECT), provided no subsequent measurement above 40%. Patients who have had an intervening medical event (e.g. myocardial infarction) or procedure (e.g. revascularization, cardiac resynchronization), must have a reassessment of EF ≥ 3 months following the event to ensure that eligibility criteria are still met. On stable doses of treatment with guideline-directed therapy, other than ACEis and ARBs prior to randomization. If the patient is currently taking an ACEi, a 36-hour washout is required prior to randomization (Visit 2). If the patient is currently taking an ARB, they must discontinue the ARB before initiation of study treatment however washout is not required. On an optimal medical regiment of diuretics and background medications to effectively treat co-morbidities such as HTN, DM, and coronary artery disease. Key Exclusion Criteria: History of hypersensitivity to any of the study drigs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEis, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs. Previous history of intolerance to sacubitril and valsartan, ACEi or ARB standard of care doses despite appropriate and gradual up-titration. History of angioedema, drug-related or otherwise. Requirement of treatment with both ACE inhibitor and ARB. Current or prior treatment with sacubitril and valsartan.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-0006

Country

United States

Facility Name

Novartis Investigative Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Novartis Investigative Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Novartis Investigative Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Novartis Investigative Site

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

Novartis Investigative Site

City

Greenwich

State/Province

Connecticut

ZIP/Postal Code

06830

Country

United States

Facility Name

Novartis Investigative Site

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06851

Country

United States

Facility Name

Novartis Investigative Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Novartis Investigative Site

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Novartis Investigative Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Novartis Investigative Site

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Novartis Investigative Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Novartis Investigative Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Novartis Investigative Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Novartis Investigative Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33312

Country

United States

Facility Name

Novartis Investigative Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Novartis Investigative Site

City

Inverness

State/Province

Florida

ZIP/Postal Code

34452

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32223

Country

United States

Facility Name

Novartis Investigative Site

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Novartis Investigative Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Augustine

State/Province

Florida

ZIP/Postal Code

32086

Country

United States

Facility Name

Novartis Investigative Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30606

Country

United States

Facility Name

Novartis Investigative Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Novartis Investigative Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

Novartis Investigative Site

City

Eatonton

State/Province

Georgia

ZIP/Postal Code

31024

Country

United States

Facility Name

Novartis Investigative Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Novartis Investigative Site

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Novartis Investigative Site

City

Fairview Heights

State/Province

Illinois

ZIP/Postal Code

62208

Country

United States

Facility Name

Novartis Investigative Site

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Novartis Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66209

Country

United States

Facility Name

Novartis Investigative Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Novartis Investigative Site

City

Eunice

State/Province

Louisiana

ZIP/Postal Code

70535

Country

United States

Facility Name

Novartis Investigative Site

City

Minden

State/Province

Louisiana

ZIP/Postal Code

71055

Country

United States

Facility Name

Novartis Investigative Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

Novartis Investigative Site

City

Slidell

State/Province

Louisiana

ZIP/Postal Code

70458

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Novartis Investigative Site

City

Alpena

State/Province

Michigan

ZIP/Postal Code

49707

Country

United States

Facility Name

Novartis Investigative Site

City

Owosso

State/Province

Michigan

ZIP/Postal Code

48867

Country

United States

Facility Name

Novartis Investigative Site

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48604

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

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Novartis Investigative Site

City

Hillsborough

State/Province

New Jersey

ZIP/Postal Code

08844

Country

United States

Facility Name

Novartis Investigative Site

City

Linden

State/Province

New Jersey

ZIP/Postal Code

07036

Country

United States

Facility Name

Novartis Investigative Site

City

Manalapan

State/Province

New Jersey

ZIP/Postal Code

07726

Country

United States

Facility Name

Novartis Investigative Site

City

Mountain Lakes

State/Province

New Jersey

ZIP/Postal Code

07046

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10469

Country

United States

Facility Name

Novartis Investigative Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Novartis Investigative Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Novartis Investigative Site

City

Rosedale

State/Province

New York

ZIP/Postal Code

11422

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28227

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Novartis Investigative Site

City

Lenoir

State/Province

North Carolina

ZIP/Postal Code

28645

Country

United States

Facility Name

Novartis Investigative Site

City

Yardley

State/Province

Pennsylvania

ZIP/Postal Code

19067

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38301

Country

United States

Facility Name

Novartis Investigative Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106-4165

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77094

Country

United States

Facility Name

Novartis Investigative Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Novartis Investigative Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75071

Country

United States

Facility Name

Novartis Investigative Site

City

Sherman

State/Province

Texas

ZIP/Postal Code

75092

Country

United States

Facility Name

Novartis Investigative Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Novartis Investigative Site

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Novartis Investigative Site

City

Richland

State/Province

Washington

ZIP/Postal Code

99352

Country

United States

Facility Name

Novartis Investigative Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Novartis Investigative Site

City

Manitowoc

State/Province

Wisconsin

ZIP/Postal Code

54220

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

35560696

Citation

Myhre PL, Claggett BL, Shah AM, Prescott MF, Ward JH, Fang JC, Mitchell GF, Solomon SD, Desai AS. Changes in cardiac biomarkers in association with alterations in cardiac structure and function, and health status in heart failure with reduced ejection fraction: the EVALUATE-HF trial. Eur J Heart Fail. 2022 Jul;24(7):1200-1208. doi: 10.1002/ejhf.2541. Epub 2022 May 30.

Results Reference

derived

PubMed Identifier

35115085

Citation

Myhre PL, Prescott MF, Murphy SP, Fang JC, Mitchell GF, Ward JH, Claggett B, Desai AS, Solomon SD, Januzzi JL. Early B-Type Natriuretic Peptide Change in HFrEF Patients Treated With Sacubitril/Valsartan: A Pooled Analysis of EVALUATE-HF and PROVE-HF. JACC Heart Fail. 2022 Feb;10(2):119-128. doi: 10.1016/j.jchf.2021.09.007. Epub 2022 Jan 12.

Results Reference

derived

PubMed Identifier

33663237

Citation

Mitchell GF, Solomon SD, Shah AM, Claggett BL, Fang JC, Izzo J, Abbas CA, Desai AS; EVALUATE-HF Investigators*. Hemodynamic Effects of Sacubitril-Valsartan Versus Enalapril in Patients With Heart Failure in the EVALUATE-HF Study: Effect Modification by Left Ventricular Ejection Fraction and Sex. Circ Heart Fail. 2021 Mar;14(3):e007891. doi: 10.1161/CIRCHEARTFAILURE.120.007891. Epub 2021 Mar 5.

Results Reference

derived

PubMed Identifier

31475296

Citation

Desai AS, Solomon SD, Shah AM, Claggett BL, Fang JC, Izzo J, McCague K, Abbas CA, Rocha R, Mitchell GF; EVALUATE-HF Investigators. Effect of Sacubitril-Valsartan vs Enalapril on Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1077-1084. doi: 10.1001/jama.2019.12843.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=514

Description

A Plain Language Trial Summary is available on novartisclinicatrials.com

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Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction

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Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction (EVALUATE-HF)

Heart Failure and Reduced Ejection Fraction

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

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