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

12 augustus 2015 bijgewerkt door: Novartis Pharmaceuticals

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

307

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Cordoba, Argentinië, X5000EVQ
        • Novartis Investigative Site
      • Cordoba, Argentinië, X5000EPU
        • Novartis Investigative Site
      • Corrientes, Argentinië, W3400
        • Novartis Investigative Site
      • Santa Fe, Argentinië, 3000
        • Novartis Investigative Site
      • Santa Fe, Argentinië, S3000FWO
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentinië, C1408INH
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Buenos Aires, Argentinië, C1119ACN
        • Novartis Investigative Site
      • Ramos Mejia, Buenos Aires, Argentinië, B1704ETD
        • Novartis Investigative Site
      • San Martin, Buenos Aires, Argentinië, B1650CSQ
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentinië, S200CVD
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentinië, T4000EBR
        • Novartis Investigative Site
  • Brazilië
    • GO
      • Goiania, GO, Brazilië, 74605-050
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazilië, 90610-000
        • Novartis Investigative Site
    • SP
      • Sao Jose do Rio Preto, SP, Brazilië, 15015-750
        • Novartis Investigative Site
      • São Paulo, SP, Brazilië, 05403-000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Z 4N5
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Novartis Investigative Site
  • Duitsland
      • Göttingen, Duitsland, D-37075
        • Novartis Investigative Site
  • Indië
      • Hyderabad, Indië, 500 063
        • Novartis Investigative Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indië, 500012
        • Novartis Investigative Site
    • Andhra Pradesh, INDIA
      • Hyderabad, Andhra Pradesh, INDIA, Indië, 500034
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, Indië, 110060
        • Novartis Investigative Site
    • Karnataka
      • Mangalore, Karnataka, Indië, 575002
        • Novartis Investigative Site
      • Manipal, Karnataka, Indië, 576104
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, Indië, 400 022
        • Novartis Investigative Site
      • Nagpur, Maharashtra, Indië, 440012
        • Novartis Investigative Site
      • Nagpur, Maharashtra, Indië, 44000033
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, Indië, 302004
        • Novartis Investigative Site
      • Jaipur, Rajasthan, Indië, 302001
        • Novartis Investigative Site
  • Italië
    • BG
      • Bergamo, BG, Italië, 24128
        • Novartis Investigative Site
    • CS
      • Cosenza, CS, Italië, 87100
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italië, 56124
        • Novartis Investigative Site
    • PV
      • Casorate Primo, PV, Italië, 27022
        • Novartis Investigative Site
    • SP
      • Sarzana, SP, Italië, 19038
        • Novartis Investigative Site
    • UD
      • San Daniele Del Friuli, UD, Italië, 33038
        • Novartis Investigative Site
    • VA
      • Somma Lombardo, VA, Italië, 21019
        • Novartis Investigative Site
  • Nederland
      • Amsterdam, Nederland, 1105 AZ
        • Novartis Investigative Site
      • Delft, Nederland, NL 2625 AD
        • Novartis Investigative Site
      • Ede, Nederland, 6716 RP
        • Novartis Investigative Site
      • Goes, Nederland, 4462 RA
        • Novartis Investigative Site
      • Groningen, Nederland, 9713 GZ
        • Novartis Investigative Site
      • Heerenveen, Nederland, 8441 PW
        • Novartis Investigative Site
      • Heerlen, Nederland, 6419 PC
        • Novartis Investigative Site
      • Hengelo, Nederland, 7555 DL
        • Novartis Investigative Site
  • Polen
      • Piotrkow Trybunalski, Polen, 97-300
        • Novartis Investigative Site
      • Sieradz, Polen, 98-200
        • Novartis Investigative Site
      • Warszawa/Anin, Polen, 04-761
        • Novartis Investigative Site
      • Wroclaw, Polen, 51-124
        • Novartis Investigative Site
      • Wroclaw, Polen, 50-981
        • Novartis Investigative Site
  • Roemenië
      • Baia Mare, Roemenië, 430031
        • Novartis Investigative Site
      • Pitesti, Roemenië, 110114
        • Novartis Investigative Site
    • Jud. Dolj
      • Craiova, Jud. Dolj, Roemenië, 200147
        • Novartis Investigative Site
    • Jud.Dolj
      • Craiova, Jud.Dolj, Roemenië, 200235
        • Novartis Investigative Site
  • Russische Federatie
      • Moscow, Russische Federatie, 117292
        • Novartis Investigative Site
      • Moscow, Russische Federatie, 121552
        • Novartis Investigative Site
      • S.-Petersburg, Russische Federatie, 196247
        • Novartis Investigative Site
      • Saint-Petersburg, Russische Federatie, 194044
        • Novartis Investigative Site
      • Saint-Petersburg, Russische Federatie, 197341
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 169609
        • Novartis Investigative Site
  • Spanje
      • Madrid, Spanje, 28034
        • Novartis Investigative Site
      • Madrid, Spanje, 28046
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spanje, 41009
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spanje, 08907
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spanje, 03004
        • Novartis Investigative Site
    • Galicia
      • A Coruna, Galicia, Spanje, 15006
        • Novartis Investigative Site
      • Santiago de Compostela, Galicia, Spanje, 15706
        • Novartis Investigative Site
  • Venezuela
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela, 1010
        • Novartis Investigative Site
    • Estado Zulia
      • Maracaibo, Estado Zulia, Venezuela, 4011
        • Novartis Investigative Site
  • Verenigde Staten
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60657
        • Novartis Investigative Site
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48201
        • Novartis Investigative Site
    • Nebraska
      • Grand Island, Nebraska, Verenigde Staten, 68803
        • Novartis Investigative Site
      • Lincoln, Nebraska, Verenigde Staten, 68506
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73120
        • Novartis Investigative Site
      • Tulsa, Oklahoma, Verenigde Staten, 74133
        • Novartis Investigative Site
    • Oregon
      • Hillsboro, Oregon, Verenigde Staten, 97123
        • Novartis Investigative Site
    • Pennsylvania
      • Wyomissing, Pennsylvania, Verenigde Staten, 19610
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Novartis Investigative Site
    • Texas
      • Houston, Texas, Verenigde Staten, 77025
        • Novartis Investigative Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: LCZ696
During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
Geneesmiddel: LCZ696
50 mg, 100 mg and 200 mg tablets
Geneesmiddel: Placebo
matching placebo to LCZ696 and Valsartan
Actieve vergelijker: Valsartan
During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
Geneesmiddel: Placebo
matching placebo to LCZ696 and Valsartan
Geneesmiddel: Valsartan
40 mg, 80 mg and 160 mg tablets

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Tijdsspanne: Baseline, 12 weeks
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.
Baseline, 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP)
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
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
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: Left Ventricular Mass
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement.
Baseline, 36 weeks
Change in Echocardiography Parameters: Isovolumic Relaxation Time
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity
Tijdsspanne: Baseline, 36 weeks
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.
Baseline, 36 weeks
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and Individual Domain Summary Scores
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
Percentage of Participants With Clinical Composite Assessment of Improved, Unchanged or Worsened
Tijdsspanne: 36 weeks
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.
36 weeks
Percentage of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Tijdsspanne: baseline, 36 weeks
eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.
baseline, 36 weeks
Change From Baseline in Serum Creatinine
Tijdsspanne: baseline, 36 weeks
Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement.
baseline, 36 weeks
Change From Baseline in Albumin/Creatinine Ratio
Tijdsspanne: baseline, 36 weeks
Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement.
baseline, 36 weeks
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
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
Change From Baseline in Arterial Stiffness Parameters: Heart Rate Correct Cen Aug/Pulse Ht
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
Change From Baseline in Arterial Stiffness Parameters: Heart Rate
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity
Tijdsspanne: baseline, 36 weeks
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.
baseline, 36 weeks
Change From Baseline in Sitting SBP, Sitting DBP and Sitting Pulse Pressure (PP)
Tijdsspanne: baseline, 36 weeks
Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.
baseline, 36 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2009

Primaire voltooiing (Werkelijk)

1 december 2011

Studie voltooiing (Werkelijk)

1 december 2011

Studieregistratiedata

Eerst ingediend

22 april 2009

Eerst ingediend dat voldeed aan de QC-criteria

23 april 2009

Eerst geplaatst (Schatting)

24 april 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

25 augustus 2015

Laatste update ingediend die voldeed aan QC-criteria

12 augustus 2015

Laatst geverifieerd

1 augustus 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLCZ696B2214
  • 2009-010208-27

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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