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Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes.

NCT ID: NCT02887183

Last Updated: 2021-10-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

794 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-25

Study Completion Date

2018-10-22

Brief Summary

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This study was to determine early and more chronic changes in concentrations of biomarkers related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapy over a period of 12 months, and correlated these biomarker changes with cardiac remodeling parameters, patient-reported outcomes and cardiovascular outcomes.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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LCZ696(sacubitril/valsartan)

Subjects received sacubitril/valsartan (LCZ696) on Day 1. The initial dose was determined by the investigator and per the approved indication described in the United States prescribing information/package insert (USPI). The three doses available were: 24/26 mg (Dose Level 1), 49/51mg (Dose Level 2) and 97/103mg (Dose Level 3).

Titration of the dosage were performed per USPI at 2 to 4 week intervals as clinically tolerated until maximal tolerated or target dosage was achieved. Target dosage was sacubitril/valsartan 97/103 mg twice daily.

Group Type OTHER

LCZ696 (sacubitril/valsartan)

Intervention Type DRUG

LCZ696 (sacubitril/valsartan) was supplied as unscored, ovaloid, film-coated oral tablets in the strengths of 24/26 mg, 49/51 mg, 97/103 mg to be taken twice daily (bid)

Interventions

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LCZ696 (sacubitril/valsartan)

LCZ696 (sacubitril/valsartan) was supplied as unscored, ovaloid, film-coated oral tablets in the strengths of 24/26 mg, 49/51 mg, 97/103 mg to be taken twice daily (bid)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Based on the USPI for sacubitril/valsartan, subjects eligible for inclusion in this study must fulfill all of the following criteria at screening and baseline:

1. Written informed consent must be obtained before any assessment is performed.
2. Men and women ≥ 18 years of age.
3. LVEF ≤ 40% subjects who are candidates for on-label sacubitril/valsartan treatment per standard of care.
4. New York Heart Association (NYHA) Functional class II-IV.
5. LVEF ≤40% via any local measurement within the past 6 months using echocardiography, multi gated acquisition scan (MUGA), CT scanning, MRI or ventricular angiography provided no subsequent study documenting an EF of \>40%. If the EF measurement is expressed as a value range, the average of the range endpoint values should be used as the EF.
6. If a subject is on a loop diuretic, they must be on a stable dose for 2 weeks prior to baseline.

Exclusion Criteria

Subjects fulfilling any of the following criteria, at screening and prior to dispensing of study drug, are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects/subjects.

1. pregnant or nursing women
2. women of child bearing potential not using highly effective method of contraception during dosing and for 7 days after stopping study medication
3. History of hypersensitivity to any of the study drugs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to angiotensin converting enzyme inhibitor (ACEIs), Angiotensin II Receptor Blockers (ARBs), or Neutral endopeptidase (NEP) inhibitors as well as known or suspected contraindications to the study drugs.
4. History of angioedema drug related or otherwise.
5. Requirement of treatment with either ACE inhibitor and/or ARB.
6. Subjects with a heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD.
7. Subjects with a cardio resynchronization therapy devices (CRT/CRT-D) implanted within 6 months of screening visit.
8. Subjects who are currently taking inotropic agents.
9. Current or prior treatment with sacubitril/valsartan.
10. Subjects taking medications prohibited by the protocol.
11. Subjects with diabetes mellitus who are taking aliskiren.
12. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
13. Concomitant use of nesiritide.
14. Bile acid sequestering agents such as cholestyramine or colestipol are prohibited to avoid interference with study drug absorption.
15. Any hospital admission/discharge related to heart failure within 2 weeks prior to baseline.
16. The use of outpatient or inpatient i.v. diuretic therapy within 2 weeks prior to baseline.
17. Enrollment in another clinical trial within 30 days of screening.
18. Potassium \> 5.2 mEq/L at screening.
19. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within one year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Fort Payne, Alabama, United States

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Novartis Investigative Site

Guntersville, Alabama, United States

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Bakersfield, California, United States

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Long Beach, California, United States

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Los Alamitos, California, United States

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Sylmar, California, United States

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West Haven, Connecticut, United States

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Belle Glade, Florida, United States

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Bradenton, Florida, United States

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Hollywood, Florida, United States

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Homestead, Florida, United States

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Jupiter, Florida, United States

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Lake Worth, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Port Orange, Florida, United States

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Wellington, Florida, United States

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Arlington Heights, Illinois, United States

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Aurora, Illinois, United States

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Lombard, Illinois, United States

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Oak Lawn, Illinois, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Crowley, Louisiana, United States

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Shreveport, Louisiana, United States

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West Monroe, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Boston, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Springfield, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Minneapolis, Minnesota, United States

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Belzoni, Mississippi, United States

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Jackson, Mississippi, United States

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Southhaven, Mississippi, United States

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Bozeman, Montana, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Nashua, New Hampshire, United States

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Buffalo, New York, United States

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Lake Success, New York, United States

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Potsdam, New York, United States

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The Bronx, New York, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Hillsboro, Oregon, United States

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Oregon City, Oregon, United States

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Portland, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Simpsonville, South Carolina, United States

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Germantown, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Bryan, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Hunstville, Texas, United States

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McKinney, Texas, United States

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Sherman, Texas, United States

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Tomball, Texas, United States

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Tyler, Texas, United States

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White River Junction, Vermont, United States

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Midlothian, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Novartis Investigative Site

Richmond, Virginia, United States

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Novartis Investigative Site

Tacoma, Washington, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37401523 (View on PubMed)

Mohebi R, Liu Y, Felker GM, Prescott MF, Pina IL, Butler J, Ward JH, Solomon SD, Januzzi JL. Prediction of Left Ventricular Ejection Fraction Change Following Treatment With Sacubitril/Valsartan. JACC Heart Fail. 2023 Jan;11(1):44-54. doi: 10.1016/j.jchf.2022.09.009. Epub 2022 Nov 9.

Reference Type DERIVED
PMID: 36599549 (View on PubMed)

Murphy SP, Ward JH, Pina IL, Felker GM, Butler J, Maisel AS, Meng X, Prescott MF, Solomon SD, Januzzi JL. Age Differences in Effects of Sacubitril/Valsartan on Cardiac Remodeling, Biomarkers, and Health Status. JACC Heart Fail. 2022 Dec;10(12):976-988. doi: 10.1016/j.jchf.2022.07.001. Epub 2022 Sep 7.

Reference Type DERIVED
PMID: 36456072 (View on PubMed)

Mohebi R, Liu Y, Pina IL, Prescott MF, Butler J, Felker GM, Ward JH, Solomon SD, Januzzi JL Jr. Dose-Response to Sacubitril/Valsartan in Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2022 Oct 18;80(16):1529-1541. doi: 10.1016/j.jacc.2022.08.737.

Reference Type DERIVED
PMID: 36229089 (View on PubMed)

Myhre PL, Prescott MF, Claggett B, Felker GM, Butler J, Pina IL, Maisel AS, Williamson KM, Ward JH, Solomon SD, Januzzi JL. Comparative Effect of Angiotensin Receptor Neprilysin Inhibition on B-type Natriuretic Peptide Levels Measured by Three Different Assays: The PROVE-HF Study. Clin Chem. 2022 Nov 3;68(11):1391-1398. doi: 10.1093/clinchem/hvac148.

Reference Type DERIVED
PMID: 36103292 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35115085 (View on PubMed)

Murphy SP, Prescott MF, Maisel AS, Butler J, Pina IL, Felker GM, Ward JH, Williamson KM, Camacho A, Kandanelly RR, Solomon SD, Januzzi JL. Association Between Angiotensin Receptor-Neprilysin Inhibition, Cardiovascular Biomarkers, and Cardiac Remodeling in Heart Failure With Reduced Ejection Fraction. Circ Heart Fail. 2021 Jun;14(6):e008410. doi: 10.1161/CIRCHEARTFAILURE.120.008410. Epub 2021 May 15.

Reference Type DERIVED
PMID: 33998243 (View on PubMed)

Khan MS, Felker GM, Pina IL, Camacho A, Bapat D, Ibrahim NE, Maisel AS, Prescott MF, Ward JH, Solomon SD, Januzzi JL, Butler J. Reverse Cardiac Remodeling Following Initiation of Sacubitril/Valsartan in Patients With Heart Failure With and Without Diabetes. JACC Heart Fail. 2021 Feb;9(2):137-145. doi: 10.1016/j.jchf.2020.09.014. Epub 2020 Dec 9.

Reference Type DERIVED
PMID: 33309581 (View on PubMed)

Murphy SP, Prescott MF, Camacho A, Iyer SR, Maisel AS, Felker GM, Butler J, Pina IL, Ibrahim NE, Abbas C, Burnett JC Jr, Solomon SD, Januzzi JL. Atrial Natriuretic Peptide and Treatment With Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2021 Feb;9(2):127-136. doi: 10.1016/j.jchf.2020.09.013. Epub 2020 Nov 11.

Reference Type DERIVED
PMID: 33189632 (View on PubMed)

Pina IL, Camacho A, Ibrahim NE, Felker GM, Butler J, Maisel AS, Prescott MF, Williamson KM, Claggett BL, Desai AS, Solomon SD, Januzzi JL; PROVE-HF Investigators. Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction. JACC Heart Fail. 2021 Jan;9(1):42-51. doi: 10.1016/j.jchf.2020.09.012. Epub 2020 Nov 11.

Reference Type DERIVED
PMID: 33189630 (View on PubMed)

Ibrahim NE, Pina IL, Camacho A, Bapat D, Felker GM, Maisel AS, Butler J, Prescott MF, Abbas CA, Solomon SD, Januzzi JL Jr; Prospective Study of Biomarkers, Symptom Improvement and Ventricular Remodeling During Entresto Therapy for Heart Failure (PROVE-HF) Study Investigators. Racial and Ethnic Differences in Biomarkers, Health Status, and Cardiac Remodeling in Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan. Circ Heart Fail. 2020 Nov;13(11):e007829. doi: 10.1161/CIRCHEARTFAILURE.120.007829. Epub 2020 Oct 3.

Reference Type DERIVED
PMID: 33016100 (View on PubMed)

Januzzi JL Jr, Prescott MF, Butler J, Felker GM, Maisel AS, McCague K, Camacho A, Pina IL, Rocha RA, Shah AM, Williamson KM, Solomon SD; PROVE-HF Investigators. Association of Change in N-Terminal Pro-B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment With Cardiac Structure and Function in Patients With Heart Failure With Reduced Ejection Fraction. JAMA. 2019 Sep 17;322(11):1085-1095. doi: 10.1001/jama.2019.12821.

Reference Type DERIVED
PMID: 31475295 (View on PubMed)

Januzzi JL, Butler J, Fombu E, Maisel A, McCague K, Pina IL, Prescott MF, Riebman JB, Solomon S. Rationale and methods of the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure (PROVE-HF). Am Heart J. 2018 May;199:130-136. doi: 10.1016/j.ahj.2017.12.021. Epub 2018 Feb 13.

Reference Type DERIVED
PMID: 29754651 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=511

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

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CLCZ696BUS13

Identifier Type: -

Identifier Source: org_study_id

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