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LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-Ventricular Ejection Fraction
This study is not yet open for participant recruitment.
Verified by Novartis, April 2009
First Received: April 22, 2009   Last Updated: April 23, 2009   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00887588
  Purpose

The study will assess the effects of 12 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.


Condition Intervention Phase
Chronic Heart Failure
Drug: LCZ696
Drug: Valsartan
Phase II

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: A Twelve-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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in log-scale in NT-proBNP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in log-scale in BNP, MR-proBNP, cGMP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in echocardiography parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Class indicators of signs and symptoms of heart failure at each visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in the overall summary score and individual domain score of the Kansas City Cardiomyopathy questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in clinical composite score (NYHA and global patient assessment score) time frame [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: June 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
LCZ696 50 mg titrated to 100 mg and 200 mg
Drug: LCZ696
LCZ696 50 mg titrated to 100 mg and 200 mg
2: Active Comparator
Valsartan 40 mg titrated to 80 mg and 160 mg
Drug: Valsartan
Valsartan 40 mg titrated to 80 mg and 160 mg

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887588

Contacts
Contact: Novartis 862-778-8300

Locations
United States, Illinois
Investigator Site
Chicago, Illinois, United States, 60657
Argentina
Investigative Site
Buenos Aires, Argentina
Brazil
Investigative Site
São Paulo, Brazil
Canada, Quebec
Investigative Site
Montreal, Quebec, Canada
India
Investigative Site
Mumbai, India
Italy
Investigative Site
Cosenza, Italy
Netherlands
Investigative Site
Amsterdam, Netherlands
Poland
Investigative Site
Wrocław, Poland
Romania
Investigative Site
Baia Mare, Romania
Russian Federation
Investigative Site
Moscow, Russian Federation
Singapore
Investigative Site
Singapore, Singapore
Spain
Investigative Site
Madrid, Spain
Venezuela
Investigative Site
Caracas, Venezuela
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: LCZ696B2214
Study First Received: April 22, 2009
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00887588     History of Changes
Health Authority: Argentina: Ministry of Health;   Brazil: Ministry of Health;   Canada: Health Canada;   India: Ministry of Health;   Italy: Ministry of Health;   Netherlands: Medicines Evaluation Board (MEB);   Poland: Ministry of Health;   Romania: Ministry of Public Health;   Russia: Pharmacological Committee, Ministry of Health;   Singapore: Health Sciences Authority;   Spain: Ministry of Health;   United States: Food and Drug Administration;   Venezuela: Ministry of Health

Keywords provided by Novartis:
Chronic heart failure
preserved ejection fraction
cardiovascular disease
NT-proBNP
biomarkers
Heart failure with preserved left-ventricular ejection
fraction

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Cardiovascular Agents
Antihypertensive Agents
Valsartan

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Valsartan

ClinicalTrials.gov processed this record on May 06, 2009