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Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting (PARASAIL)

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ClinicalTrials.gov Identifier: NCT02690974
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

The primary purpose of the study was to describe the tolerability of treatment with the optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (HFrEF) in Canada.

The study was also to describe the overall tolerability, effectiveness and safety of LCZ696 for the management of HFrEF over 12 months of treatment, as well as describe the patterns of LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.


Condition or disease Intervention/treatment Phase
Hearth Failure With Reduced Ejection Fraction (HFrEF) Drug: LCZ696 (sacubitril/valsartan) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective, Multi-center, Open lAbel, Post-appRovAl Study AImed at Characterizing the Use of LCZ696 at 97 mg Sacubitril / 103 mg Valsartan Bid in Patients With HFrEF
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : June 7, 2017
Actual Study Completion Date : November 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan

Arm Intervention/treatment
LCZ696 (sacubitril / valsartan)
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
Drug: LCZ696 (sacubitril/valsartan)
All patients were treated with the LCZ696 (sacubitril and valsartan) tablets




Primary Outcome Measures :
  1. Percentage of Participants on LCZ696 200 mg bid at Month 6 [ Time Frame: Month 6 ]
    The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 6. Only descriptive analysis done.


Secondary Outcome Measures :
  1. Percentage of Participants on LCZ696 200 mg bid at Month 12 [ Time Frame: Month 12 ]
    The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 12. Only descriptive analysis done.

  2. Percentage of Participants requiring down-titration from LCZ696 200 mg [ Time Frame: Month 12 ]
    The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the percentage of patients on LCZ696 200mg requiring down-titration. Only descriptive analysis done.

  3. Number of down-titration changes from LCZ696 200 mg during 12 months of treatment [ Time Frame: Month 12 ]
    The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the number of down-titration during the 12 months treatment period. Only descriptive analysis done.

  4. Change from Baseline in the Six Minute Walk Test (6MWT) at Month 6 and Month 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    To describe the impact of LCZ696 on functional exercise capacity, as measured by the Six Minute Walk Test, at 6 and 12 months.

  5. Time to each up-titration to LCZ696 100 mg and LCZ696 200 mg [ Time Frame: Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12 ]
    To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696.

  6. Median time to reach LCZ696 200 mg [ Time Frame: Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12 ]
    To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696

  7. Percentage of Participants on guideline recommended dose of beta-blockers and MRAs over time [ Time Frame: Baseline, Month 6 and Month 12 ]
    To describe the adherence to guideline recommended dosing of beta-blockers and MRAs at 6 and 12 months of treatment of LCZ696



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed.
  2. Age ≥ 18 years and ≤ 80 years.
  3. Males or females.
  4. Diagnosis of Heart Failure NYHA class II-III.
  5. Diagnosis of Heart Failure with reduced Ejection Fraction (LVEF < 40%) and NYHA class II or III.
  6. Stable on any dose of ACEI or ARB prior to enrolment in the study
  7. Stable on any dose of a beta-blocker prior to enrolment in the study.
  8. Eligible for treatment with LCZ696 as per Canadian product monograph.
  9. Treated as an outpatient.
  10. Signed an informed consent agreeing to participate in the study.

Key Exclusion Criteria:

  1. Symptomatic hypotension and/or a SBP < 100 mmHg at baseline visit.
  2. Estimated GFR < 30 mL/min/1.73m^2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at baseline visit.
  3. Known history of angioedema related to previous ACEI or ARBs therapy, or history of hereditary or idiopathic angioedema.
  4. Requirement of concomitant treatment with both ACEIs and ARBs.
  5. Concurrent participation in other clinical trials or receiving other investigational drugs within 30 days of enrollment.
  6. Hypersensitivity to the active substances, sacubitril or valsartan, or to any of the excipients.
  7. Concomitant use of aliskiren-containing drugs in patients with diabetes mellitus (type 1 or type 2) or moderate to severe renal impairment (GFR <60ml/min/1.73m^2).
  8. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  11. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods are described in the protocol.

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): NCT02690974


Locations
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Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Novartis Investigative Site
New Westminster, British Columbia, Canada, V3L 3W4
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Novartis Investigative Site
Moncton, New Brunswick, Canada, E1C 2Z3
Novartis Investigative Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Newfoundland and Labrador
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Novartis Investigative Site
Burlington, Ontario, Canada, L7M 4Y1
Novartis Investigative Site
Cambridge, Ontario, Canada, N1R 6V6
Novartis Investigative Site
London, Ontario, Canada, N6A 5A5
Novartis Investigative Site
Mississauga, Ontario, Canada, L5K 2L3
Novartis Investigative Site
Newmarket, Ontario, Canada, L3Y 2P6
Novartis Investigative Site
Newmarket, Ontario, Canada, L3Y 8C3
Novartis Investigative Site
Ottawa, Ontario, Canada, K1Y 4W7
Novartis Investigative Site
Peterborough, Ontario, Canada, K9J 0B2
Novartis Investigative Site
Sarnia, Ontario, Canada, N7T 4X3
Novartis Investigative Site
Scarborough, Ontario, Canada, M1E 5E9
Novartis Investigative Site
Scarborough, Ontario, Canada, M1P 2V5
Novartis Investigative Site
Sudbury, Ontario, Canada, P3E 3B8
Novartis Investigative Site
Sudbury, Ontario, Canada, P3E 5M9
Novartis Investigative Site
Toronto, Ontario, Canada, M6R 1B5
Novartis Investigative Site
Waterloo, Ontario, Canada, N2T 0C1
Novartis Investigative Site
Weston, Ontario, Canada, M9N 1W4
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2G8
Novartis Investigative Site
Joliette, Quebec, Canada, J6E 6J2
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 3Y7
Novartis Investigative Site
St-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
Novartis Investigative Site
Terrebonne, Quebec, Canada, J6V 2H2
Canada
Novartis Investigative Site
Brossard, Canada, J4Z 2K9
Novartis Investigative Site
Hamilton, Canada, L8L 0A9
Novartis Investigative Site
Quebec, Canada, GIV 4G5
Novartis Investigative Site
St-Lambert, Canada, J4P 2J2
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02690974     History of Changes
Other Study ID Numbers: CLCZ696BCA02
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HFrEF,
ACEi,
ACE inhibitor,
ARBs,
systolic heart failure,
chronic heart failure,
CHF,
reduced EF,
Ejection Fraction

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action