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

2015년 8월 12일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

307

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: LCZ696
50 mg, 100 mg and 200 mg tablets
의약품: Placebo
matching placebo to LCZ696 and Valsartan
활성 비교기: 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.
의약품: Placebo
matching placebo to LCZ696 and Valsartan
의약품: Valsartan
40 mg, 80 mg and 160 mg tablets

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: baseline, 36 weeks
Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.
baseline, 36 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 11월 1일

기본 완료 (실제)

2011년 12월 1일

연구 완료 (실제)

2011년 12월 1일

연구 등록 날짜

최초 제출

2009년 4월 22일

QC 기준을 충족하는 최초 제출

2009년 4월 23일

처음 게시됨 (추정)

2009년 4월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 8월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 8월 12일

마지막으로 확인됨

2015년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CLCZ696B2214
  • 2009-010208-27

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 심부전에 대한 임상 시험

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