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Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients (TITRATION)

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LCZ696
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Heart failure, reduced ejection fraction, LCZ696, titration, safety, tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

Exclusion Criteria:

  • Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LCZ696 Condensed

LCZ696 Conservative

Arm Description

Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks

Up-titration to LCZ696 200 mg bid over 6 weeks

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)
Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)

Secondary Outcome Measures

Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)
Treatment success was defined as the number of participants who achieved and maintained LCZ696 200 mg bid without any dose interruption or down-titration over 12 weeks and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)
Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).
Tolerability was assessed as the number of participants who achieved LCZ696 200 mg bid and maintained this dose for at least 2 weeks before study completion, regardless of previous dose interruption or down-titration and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)

Full Information

First Posted
August 12, 2013
Last Updated
September 16, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01922089
Brief Title
Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients
Acronym
TITRATION
Official Title
A Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients Comparing Two Titration Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
Heart failure, reduced ejection fraction, LCZ696, titration, safety, tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCZ696 Condensed
Arm Type
Experimental
Arm Description
Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
Arm Title
LCZ696 Conservative
Arm Type
Experimental
Arm Description
Up-titration to LCZ696 200 mg bid over 6 weeks
Intervention Type
Drug
Intervention Name(s)
LCZ696
Intervention Description
LCZ696 50 mg/100 mg/200 mg bid
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)
Description
Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)
Description
Treatment success was defined as the number of participants who achieved and maintained LCZ696 200 mg bid without any dose interruption or down-titration over 12 weeks and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)
Time Frame
12 weeks
Title
Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).
Description
Tolerability was assessed as the number of participants who achieved LCZ696 200 mg bid and maintained this dose for at least 2 weeks before study completion, regardless of previous dose interruption or down-titration and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers Exclusion Criteria: Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Novartis Investigative Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Novartis Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Novartis Investigative Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Novartis Investigative Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Novartis Investigative Site
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Novartis Investigative Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Novartis Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Novartis Investigative Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Novartis Investigative Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Novartis Investigative Site
City
Laurelton
State/Province
New York
ZIP/Postal Code
11422
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United States
Facility Name
Novartis Investigative Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
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United States
Facility Name
Novartis Investigative Site
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
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United States
Facility Name
Novartis Investigative Site
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Dallas
State/Province
Texas
ZIP/Postal Code
75231
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United States
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Novartis Investigative Site
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Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
Facility Name
Novartis Investigative Site
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Houston
State/Province
Texas
ZIP/Postal Code
77094
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United States
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Novartis Investigative Site
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Livingston
State/Province
Texas
ZIP/Postal Code
77351
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United States
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Novartis Investigative Site
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Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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United States
Facility Name
Novartis Investigative Site
City
Gabrovo
ZIP/Postal Code
5300
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Bulgaria
Facility Name
Novartis Investigative Site
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Plovdiv
ZIP/Postal Code
4000
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Bulgaria
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4004
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Bulgaria
Facility Name
Novartis Investigative Site
City
Smolian
ZIP/Postal Code
4700
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Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1202
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Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1407
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Bulgaria
Facility Name
Novartis Investigative Site
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland
Facility Name
Novartis Investigative Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novartis Investigative Site
City
Bad Krozingen
ZIP/Postal Code
79189
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Germany
Facility Name
Novartis Investigative Site
City
Berlin-Buch
ZIP/Postal Code
13125
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Germany
Facility Name
Novartis Investigative Site
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Berlin
ZIP/Postal Code
10367
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Germany
Facility Name
Novartis Investigative Site
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Berlin
ZIP/Postal Code
10787
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Germany
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Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13405
Country
Germany
Facility Name
Novartis Investigative Site
City
Dietzenbach
ZIP/Postal Code
63128
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Germany
Facility Name
Novartis Investigative Site
City
Ebersbach
ZIP/Postal Code
02730
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60594
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Germany
Facility Name
Novartis Investigative Site
City
Göttingen
ZIP/Postal Code
D-37075
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Germany
Facility Name
Novartis Investigative Site
City
Hassloch
ZIP/Postal Code
67454
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Germany
Facility Name
Novartis Investigative Site
City
Huy / OT Anderbeck
ZIP/Postal Code
38836
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Germany
Facility Name
Novartis Investigative Site
City
Ingelheim
ZIP/Postal Code
55218
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Germany
Facility Name
Novartis Investigative Site
City
Kelkheim
ZIP/Postal Code
65779
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Germany
Facility Name
Novartis Investigative Site
City
Kleve
ZIP/Postal Code
47533
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Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04315
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Germany
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Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55116
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Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
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Germany
Facility Name
Novartis Investigative Site
City
Mühlheim
ZIP/Postal Code
45468
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Germany
Facility Name
Novartis Investigative Site
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Novartis Investigative Site
City
Straubing
ZIP/Postal Code
94315
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Germany
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97078
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Germany
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1042
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1145
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Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
H-1096
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Mosonmagyarovar
ZIP/Postal Code
9200
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Hungary
Facility Name
Novartis Investigative Site
City
Nyiregyháza
ZIP/Postal Code
4400
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Hungary
Facility Name
Novartis Investigative Site
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Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szekesfehervar
ZIP/Postal Code
8000
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Hungary
Facility Name
Novartis Investigative Site
City
Aosta
State/Province
AO
ZIP/Postal Code
11100
Country
Italy
Facility Name
Novartis Investigative Site
City
Cortona
State/Province
AR
ZIP/Postal Code
52044
Country
Italy
Facility Name
Novartis Investigative Site
City
Bergamo
State/Province
BG
ZIP/Postal Code
24128
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Italy
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Cona
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Novartis Investigative Site
City
Albano Laziale
State/Province
RM
ZIP/Postal Code
00041
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00163
Country
Italy
Facility Name
Novartis Investigative Site
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy
Facility Name
Novartis Investigative Site
City
Vittorio Veneto
State/Province
TV
ZIP/Postal Code
31029
Country
Italy
Facility Name
Novartis Investigative Site
City
San Daniele Del Friuli
State/Province
UD
ZIP/Postal Code
33038
Country
Italy
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00936-6528
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Brezno
State/Province
Slovak Republic
ZIP/Postal Code
977 42
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nitra
State/Province
Slovak Republic
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Svidnik
State/Province
Slovak Republic
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
821 07
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
83301
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Lucenec
ZIP/Postal Code
98439
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Trebisov
ZIP/Postal Code
075 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Almeria
State/Province
Andalucia
ZIP/Postal Code
04120
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Sanlucar de Barrameda
State/Province
Andalucia
ZIP/Postal Code
11540
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41014
Country
Spain
Facility Name
Novartis Investigative Site
City
Villamartin
State/Province
Cadiz
ZIP/Postal Code
11650
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
A Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Novartis Investigative Site
City
Haydarpasa/Istanbul
ZIP/Postal Code
34668
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34304
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
Novartis Investigative Site
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Novartis Investigative Site
City
Dorchester
State/Province
Dorset
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
St Leonards on Sea
State/Province
East Sussex
ZIP/Postal Code
TN37 7RD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Oldham
State/Province
Lancashire
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Gateshead
State/Province
Tyne and Wear
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29164797
Citation
Senni M, McMurray JJV, Wachter R, McIntyre HF, Anand IS, Duino V, Sarkar A, Shi V, Charney A. Impact of systolic blood pressure on the safety and tolerability of initiating and up-titrating sacubitril/valsartan in patients with heart failure and reduced ejection fraction: insights from the TITRATION study. Eur J Heart Fail. 2018 Mar;20(3):491-500. doi: 10.1002/ejhf.1054. Epub 2017 Nov 22.
Results Reference
derived
PubMed Identifier
27170530
Citation
Senni M, McMurray JJ, Wachter R, McIntyre HF, Reyes A, Majercak I, Andreka P, Shehova-Yankova N, Anand I, Yilmaz MB, Gogia H, Martinez-Selles M, Fischer S, Zilahi Z, Cosmi F, Gelev V, Galve E, Gomez-Doblas JJ, Nociar J, Radomska M, Sokolova B, Volterrani M, Sarkar A, Reimund B, Chen F, Charney A. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double-blind, randomized comparison of two uptitration regimens. Eur J Heart Fail. 2016 Sep;18(9):1193-202. doi: 10.1002/ejhf.548. Epub 2016 May 12.
Results Reference
derived

Learn more about this trial

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

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