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Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event (TRANSITION)

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

LCZ696

About this trial

This is an interventional supportive care trial for Heart Failure With Reduced Ejection Fraction focused on measuring Acute decompensated heart failure, Reduced ejection fraction, Pre-discharge treatment, Post-discharge treatment, Angiotensin receptor neprilysine inhibitor, HFrEF

Eligibility Criteria

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

Inclusion Criteria:

Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs & Symptoms
Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
Meeting one of the following criteria:
- Patients on any dose of ACEI or ARB at screening
- ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening.

Exclusion Criteria:

History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients.
Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
Serum potassium above 5.4 mmol/L at Randomization.
Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
Severe hepatic impairment, biliary cirrhosis and cholestasis

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Pre-discharge treatment initiation

Post-discharge treatment initiation

Arm Description

Patients received first dose at any point after Randomization but no later than 12 h before discharge.

Patients received first dose after discharge and up to 14 days thereafter.

Outcomes

Primary Outcome Measures

Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization

Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10

Secondary Outcome Measures

Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid

Percentage of patients achieving and maintaining either LCZ696 100 mg and/or 200 mg bid for at least 2 weeks leading to Week 10

Percentage of Patients Achieving and Maintaining Any Dose of LCZ696

Percentage of patients achieving any dose of LCZ696 for at least 2 weeks leading to 10 weeks of treatment

Percentage of Patients Permanently Discontinued From Treatment

Percentage of patients permanently discontinued from LCZ696 (1) up to week 10 due to AEs, and (2) up to week 26 due to any reasons

Full Information

NCT ID

NCT02661217

First Posted

January 19, 2016

Last Updated

March 29, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02661217

Brief Title

Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

Acronym

TRANSITION

Official Title

A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 12, 2016 (Actual)

Primary Completion Date

February 20, 2018 (Actual)

Study Completion Date

June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

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

Acute decompensated heart failure, Reduced ejection fraction, Pre-discharge treatment, Post-discharge treatment, Angiotensin receptor neprilysine inhibitor, HFrEF

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1002 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pre-discharge treatment initiation

Arm Type

Other

Arm Description

Patients received first dose at any point after Randomization but no later than 12 h before discharge.

Arm Title

Post-discharge treatment initiation

Arm Type

Other

Arm Description

Patients received first dose after discharge and up to 14 days thereafter.

Intervention Type

Drug

Intervention Name(s)

LCZ696

Intervention Description

LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food. The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient.

Primary Outcome Measure Information:

Title

Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization

Description

Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10

Time Frame

10 weeks after Randomization

Secondary Outcome Measure Information:

Title

Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid

Description

Percentage of patients achieving and maintaining either LCZ696 100 mg and/or 200 mg bid for at least 2 weeks leading to Week 10

Time Frame

10 weeks after Randomization

Title

Percentage of Patients Achieving and Maintaining Any Dose of LCZ696

Description

Percentage of patients achieving any dose of LCZ696 for at least 2 weeks leading to 10 weeks of treatment

Time Frame

10 weeks after Randomization

Title

Percentage of Patients Permanently Discontinued From Treatment

Description

Percentage of patients permanently discontinued from LCZ696 (1) up to week 10 due to AEs, and (2) up to week 26 due to any reasons

Time Frame

10 weeks after Randomization AND 26 weeks after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs & Symptoms Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization Stabilized (while in the hospital) for at least 24 hours leading to Randomization. Meeting one of the following criteria: Patients on any dose of ACEI or ARB at screening ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening. Exclusion Criteria: History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients. Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization. Serum potassium above 5.4 mmol/L at Randomization. Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy Severe hepatic impairment, biliary cirrhosis and cholestasis

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

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878DKF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Villa Maria

State/Province

Cordoba

ZIP/Postal Code

X5900JKA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1405CNF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1426BOR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

Novartis Investigative Site

City

Tucuman

ZIP/Postal Code

T4000NIJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Huy

ZIP/Postal Code

4500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ronse

ZIP/Postal Code

9600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Novartis Investigative Site

City

Karlovy Vary

State/Province

Czech Republic

ZIP/Postal Code

360 66

Country

Czechia

Facility Name

Novartis Investigative Site

City

Liberec

State/Province

Czech Republic

ZIP/Postal Code

460 63

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tabor

State/Province

Czech Republic

ZIP/Postal Code

39003

Country

Czechia

Facility Name

Novartis Investigative Site

City

Trebic

State/Province

Czech Republic

ZIP/Postal Code

674 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Beroun

State/Province

CZE

ZIP/Postal Code

26601

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava

State/Province

CZE

ZIP/Postal Code

72880

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno Bohunice

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

JIhlava

ZIP/Postal Code

586 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kolin

ZIP/Postal Code

280 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Slany

ZIP/Postal Code

274 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

Novartis Investigative Site

City

Besancon cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 10

ZIP/Postal Code

75010

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Tourcoing

ZIP/Postal Code

59200

Country

France

Facility Name

Novartis Investigative Site

City

Valenciennes

ZIP/Postal Code

59300

Country

France

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68305

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Leverkusen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51375

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44379

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45356

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

65929

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln-Nippes

ZIP/Postal Code

50733

Country

Germany

Facility Name

Novartis Investigative Site

City

Langen

ZIP/Postal Code

63225

Country

Germany

Facility Name

Novartis Investigative Site

City

Lübeck

ZIP/Postal Code

23569

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Moenchengladbach

ZIP/Postal Code

41063

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

Novartis Investigative Site

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Novartis Investigative Site

City

Ruesselsheim

ZIP/Postal Code

65428

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58455

Country

Germany

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novartis Investigative Site

City

Cremona

State/Province

ZIP/Postal Code

26100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00152

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Novartis Investigative Site

City

El Chouf

State/Province

LBN

ZIP/Postal Code

1503201002

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Ashrafieh

ZIP/Postal Code

166830

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

1107 2020

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Saida

ZIP/Postal Code

652

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Alesund

ZIP/Postal Code

NO-6026

Country

Norway

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

5009

Country

Norway

Facility Name

Novartis Investigative Site

City

Gralum

ZIP/Postal Code

1714

Country

Norway

Facility Name

Novartis Investigative Site

City

Lillehammer

ZIP/Postal Code

2629

Country

Norway

Facility Name

Novartis Investigative Site

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

90 549

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31202

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

61-848

Country

Poland

Facility Name

Novartis Investigative Site

City

Pulawy

ZIP/Postal Code

24100

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04-749

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50 420

Country

Poland

Facility Name

Novartis Investigative Site

City

Vila Real

State/Province

Portuigal

ZIP/Postal Code

5000-508

Country

Portugal

Facility Name

Novartis Investigative Site

City

Amadora

ZIP/Postal Code

2720-276

Country

Portugal

Facility Name

Novartis Investigative Site

City

Aveiro

ZIP/Postal Code

3814-501

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Covilha

ZIP/Postal Code

6200-251

Country

Portugal

Facility Name

Novartis Investigative Site

City

Guimaraes

ZIP/Postal Code

4835-044

Country

Portugal

Facility Name

Novartis Investigative Site

City

Leiria

ZIP/Postal Code

2410-187

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1495 005

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1500 650

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Gatchina

ZIP/Postal Code

188300

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117556

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150047

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Dammam

ZIP/Postal Code

31463

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Jeddah

ZIP/Postal Code

21499

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Riyadh

ZIP/Postal Code

11211

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Dunajska Streda

State/Province

Slovak Republic

ZIP/Postal Code

92901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

4190

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Mikulas

State/Province

Slovak Republic

ZIP/Postal Code

031 23

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

833 48

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Dolny Kubin

ZIP/Postal Code

026 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Rimavska Sobota

ZIP/Postal Code

97912

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

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

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Barcelona/ Cataluny/Espanya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Villamartin

State/Province

Cadiz

ZIP/Postal Code

11650

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

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

La Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Olot

State/Province

Girona

ZIP/Postal Code

17800

Country

Spain

Facility Name

Novartis Investigative Site

City

Mostoles

State/Province

Madrid

ZIP/Postal Code

28935

Country

Spain

Facility Name

Novartis Investigative Site

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35010

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Goteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Joenkoeping

ZIP/Postal Code

551 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Geneve 14

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Eskisehir

State/Province

Meselik

ZIP/Postal Code

26480

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

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

33343

Country

Turkey

Facility Name

Novartis Investigative Site

City

Sivas

ZIP/Postal Code

58140

Country

Turkey

Facility Name

Novartis Investigative Site

City

Westcliff on Sea

State/Province

Essex

ZIP/Postal Code

SS0 0RY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Ashford

State/Province

Kent

ZIP/Postal Code

TN24 0LZ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bridgend

State/Province

Mid Glamorgan

ZIP/Postal Code

CF31 1RQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Portadown

State/Province

Nothern Ireland

ZIP/Postal Code

BT63 5QQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sunderland

State/Province

Tyne And Wear

ZIP/Postal Code

SR4 7TP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blackpool

ZIP/Postal Code

FY3 8NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE 3 9QP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC14 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Swindon

ZIP/Postal Code

SN3 6BB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

York

ZIP/Postal Code

YO31 8HE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32800508

Citation

Pascual-Figal D, Wachter R, Senni M, Bao W, Noe A, Schwende H, Butylin D, Prescott MF; TRANSITION Investigators. NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study. JACC Heart Fail. 2020 Oct;8(10):822-833. doi: 10.1016/j.jchf.2020.05.012. Epub 2020 Aug 12.

Results Reference

derived

PubMed Identifier

31820537

Citation

Senni M, Wachter R, Witte KK, Straburzynska-Migaj E, Belohlavek J, Fonseca C, Mueller C, Lonn E, Chakrabarti A, Bao W, Noe A, Schwende H, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study. Eur J Heart Fail. 2020 Feb;22(2):303-312. doi: 10.1002/ejhf.1670. Epub 2019 Dec 9.

Results Reference

derived

PubMed Identifier

31134724

Citation

Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bohmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, A L Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noe A, Schwende H, Bao W, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. Eur J Heart Fail. 2019 Aug;21(8):998-1007. doi: 10.1002/ejhf.1498. Epub 2019 May 27.

Results Reference

derived

PubMed Identifier

29239515

Citation

Pascual-Figal D, Wachter R, Senni M, Belohlavek J, Noe A, Carr D, Butylin D. Rationale and design of TRANSITION: a randomized trial of pre-discharge vs. post-discharge initiation of sacubitril/valsartan. ESC Heart Fail. 2018 Apr;5(2):327-336. doi: 10.1002/ehf2.12246. Epub 2017 Dec 14.

Results Reference

derived

Learn more about this trial

Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

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Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event (TRANSITION)

Heart Failure With Reduced Ejection Fraction

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial