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Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04164732
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to determine if LCZ696 is safe, tolerable and can improve exercise capacity (via improved peak VO2) in non-obstructive HCM patient population over the course of 50 weeks of treatment.

Condition or disease Intervention/treatment Phase
Cardiomyopathy, Hypertrophic Drug: LCZ696 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Investigator and subject will be blinded to treatment allocation during the treatment period
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Placebo-controlled Patient and Investigator-blinded Study to Explore the Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (nHCM)
Actual Study Start Date : January 8, 2020
Estimated Primary Completion Date : May 23, 2022
Estimated Study Completion Date : May 23, 2022


Arm Intervention/treatment
Experimental: LCZ696 at doses of 50mg, 100mg and 200mg b.i.d
randomized in a 1:1 ratio: LCZ696 to placebo
Drug: LCZ696
LCZ696 at doses of 50mg, 100mg and 200mg b.i.d oral
Other Names:
  • sacubitril
  • valsartan

Placebo Comparator: Placebo to LCZ696
randomized in a 1:1 ratio: LCZ696 to placebo
Drug: Placebo
placebo




Primary Outcome Measures :
  1. Change from baseline in peak VO2 as measured by cardiopulmonary exercise test (CPET) [ Time Frame: Baseline to 50 weeks ]
    The primary analysis will assess the effect of LCZ696 on the change from baseline in peak VO2 (ml/kg/min) at week 50 compared to placebo, where baseline peak VO2 will come from the screening/baseline CPET.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Hypertrophic Cardiomyopathy with a left ventricular wall thickness greater than or equal to 13mm as determined by the echocardiogram obtained during the screening/baseline period
  • Left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by echocardiogram obtained during the screening/baseline period
  • Symptoms consistent with New York Heart Association (NYHA) Class II-III heart failure by physician assessment, or asymptomatic/NYHA Class I patients with:

    • NT-proBNP blood sample levels above 250 pg/ml and
    • peak VO2 of less than or equal to 80% of predicted based on age and gender as determined by cardiopulmonary exercise testing

Exclusion Criteria:

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for ≥7 days after stopping study drug
  • Patients with a resting or provokable left ventricular outflow tract gradient of greater than or equal to 30mm Hg
  • Septal reduction procedure within 3 months of the screening/baseline visit
  • History of atrial fibrillation within 6 months of the screening/baseline visit or placement of ICD for secondary prevention
  • Patients with a peak VO2 on the screening/baseline cardiopulmonary exercise test of > 80% of predicted based on age and gender
  • Patients who require treatment with ACE inhibitors, angiotensin receptor blockers (ARBs), or renin inhibitors
  • Known infiltrative or storage disorder such as Fabry disease, or amyloidosis
  • Known or suspected symptomatic coronary artery diseases or evidence of prior myocardial infarction
  • Systolic blood pressure of <100 mmHg or symptomatic hypotension during the screening/baseline period or treatment run-in period
  • Contraindication to ARB administration or prior history of angioedema
  • Persistent uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164732


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Stanford, California, United States, 94305-5826
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02111
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Novartis Investigative Site Recruiting
Ann Arbor, Michigan, United States, 48109 5271
United States, New Jersey
Novartis Investigative Site Recruiting
Morristown, New Jersey, United States, 07960
Finland
Novartis Investigative Site Recruiting
Tampere, Finland, 33520
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 10789
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Kiel, Germany, 24105
Greece
Novartis Investigative Site Recruiting
Athens, GR, Greece, 151 23
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 03722
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 05505
Spain
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Recruiting
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Recruiting
Madrid, Spain, 28222
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04164732    
Other Study ID Numbers: CLCZ696I12201
2019-003098-24 ( EudraCT Number )
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
non-obstructive
hypertrophic cardiomyopathy
genetic cardiomyopathy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action