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Chronic Heart FailurePhase 2NCT00887588

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

A Phase 2 study testing LCZ696 and Valsartan in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 81 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
LCZ696 and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
307 participants
Where
81 sitesin 14 countries
Study dates
Nov 2009to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

81 sites in 14 countries.

81 sites in 14 countries

United States11 sites

  • Novartis Investigative Site

    Chicago, Illinois, 60657

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Grand Island, Nebraska, 68803

  • Novartis Investigative Site

    Hillsboro, Oregon, 97123

  • Novartis Investigative Site

    Houston, Texas, 77025

  • Novartis Investigative Site

    Lincoln, Nebraska, 68506

  • Novartis Investigative Site

    Little Rock, Arkansas, 72205

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73120

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74133

  • Novartis Investigative Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Argentina11 sites

  • Novartis Investigative Site

    Caba, Buenos Aires, C1408INH

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000EPU

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000EVQ

  • Novartis Investigative Site

    Corrientes, Corrientes Province, W3400

  • Novartis Investigative Site

    Ramos Mejía, Buenos Aires, B1704ETD

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S200CVD

  • Novartis Investigative Site

    San Martín, Buenos Aires, B1650CSQ

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000EBR

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, 3000

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000FWO

Other trials in Argentina

India11 sites

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500012

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, India, 500034

  • Novartis Investigative Site

    Hyderabad, 500 063

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302001

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302004

  • Novartis Investigative Site

    Mangalore, Karnataka, 575002

  • Novartis Investigative Site

    Manipal, Karnataka, 576104

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400 022

  • Novartis Investigative Site

    Nagpur, Maharashtra, 44000033

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440012

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

Other trials in India

Netherlands8 sites

  • Novartis Investigative Site

    Amsterdam, 1105 AZ

  • Novartis Investigative Site

    Delft, NL 2625 AD

  • Novartis Investigative Site

    Ede, Netherlands, 6716 RP

  • Novartis Investigative Site

    Goes, 4462 RA

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Heerenveen, 8441 PW

  • Novartis Investigative Site

    Heerlen, 6419 PC

  • Novartis Investigative Site

    Hengelo, 7555 DL

Other trials in Netherlands

Italy7 sites

  • Novartis Investigative Site

    Bergamo, BG, 24128

  • Novartis Investigative Site

    Casorate Primo, PV, 27022

  • Novartis Investigative Site

    Cosenza, CS, 87100

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    San Daniele del Friuli, UD, 33038

  • Novartis Investigative Site

    Sarzana, SP, 19038

  • Novartis Investigative Site

    Somma Lombardo, VA, 21019

Other trials in Italy

Spain7 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Alicante, Valencia, 03004

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    Madrid, Madrid, 28034

  • Novartis Investigative Site

    Madrid, Madrid, 28046

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

Other trials in Spain

Poland5 sites

  • Novartis Investigative Site

    Piotrkow Trybunalski, 97-300

  • Novartis Investigative Site

    Sieradz, 98-200

  • Novartis Investigative Site

    Warszawa/Anin, Poland, 04-761

  • Novartis Investigative Site

    Wroclaw, 50-981

  • Novartis Investigative Site

    Wroclaw, 51-124

Other trials in Poland

Russia5 sites

  • Novartis Investigative Site

    Moscow, 117292

  • Novartis Investigative Site

    Moscow, 121552

  • Novartis Investigative Site

    S.-Petersburg, 196247

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saint Petersburg, 197341

Other trials in Russia

Brazil4 sites

  • Novartis Investigative Site

    Goiânia, Goiás, 74605-050

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15015-750

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Romania4 sites

  • Novartis Investigative Site

    Baia Mare, 430031

  • Novartis Investigative Site

    Craiova, Jud. Dolj, 200147

  • Novartis Investigative Site

    Craiova, Jud.Dolj, 200235

  • Novartis Investigative Site

    Piteşti, 110114

Other trials in Romania

Canada3 sites

  • Novartis Investigative Site

    Brampton, Ontario, L6Z 4N5

  • Novartis Investigative Site

    Montreal, Quebec, H3A 1A1

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1A4

Other trials in Canada

Singapore2 sites

  • Novartis Investigative Site

    Singapore, Singapore, 119074

  • Novartis Investigative Site

    Singapore, Singapore, 169609

Other trials in Singapore

Venezuela2 sites

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1010

  • Novartis Investigative Site

    Maracaibo, Zulia, 4011

Other trials in Venezuela

Germany1 site

  • Novartis Investigative Site

    Göttingen, D-37075

Other trials in Germany

About this study

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

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.

Being tested
LCZ696, Valsartan, Placebo
Keywords
Chronic heart failure, preserved ejection fraction, cardiovascular disease, NT-proBNP, biomarkers, Heart failure with preserved left-ventricular ejection, fraction
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCZ696Drug

    50 mg, 100 mg and 200 mg tablets

  • ValsartanDrug

    40 mg, 80 mg and 160 mg tablets

  • PlaceboDrug

    matching placebo to LCZ696 and Valsartan

Study groups in NCT00887588
Study groupRoleWhat they receive
LCZ696ExperimentalDuring 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.
Receives: Drug: LCZ696; Drug: Placebo
ValsartanActive comparatorDuring 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.
Receives: Drug: Valsartan; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12 weeks

Secondary outcomes (23)

  1. 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.

    Measured: baseline, 36 weeks

  2. 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.

    Measured: baseline, 36 weeks

  3. 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.

    Measured: Baseline, 36 weeks

  4. 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.

    Measured: Baseline, 36 weeks

  5. 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.

    Measured: Baseline, 36 weeks

  6. 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.

    Measured: Baseline, 36 weeks

  7. 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.

    Measured: Baseline, 36 weeks

  8. 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.

    Measured: Baseline, 36 weeks

  9. 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.

    Measured: Baseline, 36 weeks

  10. 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.

    Measured: Baseline, 36 weeks

  11. 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.

    Measured: Baseline, 36 weeks

  12. 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.

    Measured: Baseline, 36 weeks

  13. 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.

    Measured: baseline, 36 weeks

  14. 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.

    Measured: 36 weeks

  15. 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.

    Measured: baseline, 36 weeks

  16. 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.

    Measured: baseline, 36 weeks

  17. Change From Baseline in Serum Creatinine

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

    Measured: baseline, 36 weeks

  18. Change From Baseline in Albumin/Creatinine Ratio

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

    Measured: baseline, 36 weeks

  19. 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.

    Measured: baseline, 36 weeks

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

    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.

    Measured: baseline, 36 weeks

  21. Change From Baseline in Arterial Stiffness Parameters: Heart Rate

    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.

    Measured: baseline, 36 weeks

  22. Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity

    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.

    Measured: baseline, 36 weeks

  23. 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.

    Measured: baseline, 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887588
Sponsor's protocol ID
CLCZ696B2214
Other IDs
2009-010208-27, 2009
Status last verified
Aug 2015
First submitted
22 Apr 2009
Last updated
25 Aug 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22932717

  • 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.

    PubMed 37401523

  • Biering-Sorensen T, Lassen MCH, Shah A, Claggett B, Zile M, Pieske B, Pieske-Kraigher E, Voors A, Shi V, Lefkowitz M, Packer M, McMurray JJV, Solomon SD; PARAMOUNT Investigators. The Effect of Sacubitril/Valsartan on Left Ventricular Myocardial Deformation in Heart Failure with Preserved Ejection Fraction (PARAMOUNT trial). J Card Fail. 2023 Jun;29(6):968-973. doi: 10.1016/j.cardfail.2023.03.019. Epub 2023 Apr 7.

    PubMed 37031887

  • 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.

    PubMed 30354399

  • 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.

    PubMed 26754625

  • 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.

    PubMed 26280447

  • 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.

    PubMed 25277997

  • 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.

    PubMed 25138249

  • 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.

    PubMed 24184245

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCZ696 and Valsartan in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 81 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Argentina, India, Netherlands, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00887588, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.

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