Heart Failure With Reduced Ejection FractionPhase 4TRANSITIONNCT02661217
Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
A Phase 4 study testing LCZ696 in people with Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 152 sites in 19 countries.
Trial summary
To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- LCZ696
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 152 sitesin 19 countries
- Study dates
- 12 Feb 2016to 20 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
152 sites in 19 countries.
152 sites in 19 countries
Germany21 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Dortmund, 44379
Novartis Investigative Site
Erfurt, 99089
Novartis Investigative Site
Essen, 45356
Novartis Investigative Site
Frankfurt, 65929
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Koeln-Nippes, 50733
Novartis Investigative Site
Langen, 63225
Novartis Investigative Site
Leverkusen, North Rhine-Westphalia, 51375
Novartis Investigative Site
Lübeck, 23569
Novartis Investigative Site
Magdeburg, 39120
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68305
Novartis Investigative Site
Mönchengladbach, 41063
Novartis Investigative Site
Neuwied, 56564
Novartis Investigative Site
Oldenburg, 26133
Novartis Investigative Site
Regensburg, Bavaria, 93053
Novartis Investigative Site
Rüsselsheim am Main, 65428
Novartis Investigative Site
Witten, 58455
United Kingdom16 sites
Novartis Investigative Site
Ashford, Kent, TN24 0LZ
Novartis Investigative Site
Basingstoke, Hampshire, RG24 9NA
Novartis Investigative Site
Blackpool, FY3 8NR
Novartis Investigative Site
Bridgend, Mid Glamorgan, CF31 1RQ
Novartis Investigative Site
Leeds, LS1 3EX
Novartis Investigative Site
Leicester, LE 3 9QP
Novartis Investigative Site
Liverpool, L9 7AL
Novartis Investigative Site
London, EC14 7BE
Novartis Investigative Site
Middlesbrough, TS4 3BW
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
Novartis Investigative Site
Norwich, NR4 7UY
Novartis Investigative Site
Portadown, Nothern Ireland, BT63 5QQ
Novartis Investigative Site
Sunderland, Tyne and Wear, SR4 7TP
Novartis Investigative Site
Swindon, SN3 6BB
Novartis Investigative Site
Westcliff-on-Sea, Essex, SS0 0RY
Novartis Investigative Site
York, YO31 8HE
Spain15 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Barcelona, Barcelona/ Cataluny/Espanya, 08035
Novartis Investigative Site
El Palmar, Murcia, 30120
Novartis Investigative Site
Las Palmas de Gran Canaria, 35010
Novartis Investigative Site
Madrid, 28222
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Móstoles, Madrid, 28935
Novartis Investigative Site
Olot, Girona, 17800
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigative Site
Valencia, Valencia, 46014
Novartis Investigative Site
Valencia, Valencia, 46026
Novartis Investigative Site
Villamartín, Cadiz, 11650
Czechia14 sites
Novartis Investigative Site
Beroun, CZE, 26601
Novartis Investigative Site
Brno, Czech Republic, 656 91
Novartis Investigative Site
Brno-Bohunice, 625 00
Novartis Investigative Site
Jihlava, 586 01
Novartis Investigative Site
Karlovy Vary, Czech Republic, 360 66
Novartis Investigative Site
Kolín, 280 20
Novartis Investigative Site
Liberec, Czech Republic, 460 63
Novartis Investigative Site
Olomouc, 775 20
Novartis Investigative Site
Ostrava, CZE, 72880
Novartis Investigative Site
Prague, 100 34
Novartis Investigative Site
Prague, 12808
Novartis Investigative Site
Slaný, 274 01
Novartis Investigative Site
Tábor, Czech Republic, 39003
Novartis Investigative Site
Třebíč, Czech Republic, 674 01
Portugal12 sites
Novartis Investigative Site
Amadora, 2720-276
Novartis Investigative Site
Aveiro, 3814-501
Novartis Investigative Site
Coimbra, 3000-075
Novartis Investigative Site
Covilha, 6200-251
Novartis Investigative Site
Guimarães, 4835-044
Novartis Investigative Site
Leiria, 2410-187
Novartis Investigative Site
Lisbon, 1495 005
Novartis Investigative Site
Lisbon, 1500 650
Novartis Investigative Site
Lisbon, 1649-035
Novartis Investigative Site
Porto, 4099-001
Novartis Investigative Site
Porto, 4200-319
Novartis Investigative Site
Vila Real, Portuigal, 5000-508
Slovakia10 sites
Novartis Investigative Site
Bratislava, 826 06
Novartis Investigative Site
Bratislava, 833 48
Novartis Investigative Site
Dolný Kubín, 026 01
Novartis Investigative Site
Dunajská Streda, Slovak Republic, 92901
Novartis Investigative Site
Košice, Slovak Republic, 4190
Novartis Investigative Site
Liptovský Mikuláš, Slovak Republic, 031 23
Novartis Investigative Site
Martin, 036 59
Novartis Investigative Site
Prešov, 080 01
Novartis Investigative Site
Rimavská Sobota, 97912
Novartis Investigative Site
Trnava, 917 75
Russia8 sites
Novartis Investigative Site
Gatchina, 188300
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 117292
Novartis Investigative Site
Moscow, 117556
Novartis Investigative Site
Moscow, 123182
Novartis Investigative Site
Saint Petersburg, 193312
Novartis Investigative Site
Saint Petersburg, 199106
Novartis Investigative Site
Yaroslavl, 150047
Argentina7 sites
Novartis Investigative Site
Buenos Aires, C1405CNF
Novartis Investigative Site
Buenos Aires, C1426BOR
Novartis Investigative Site
Córdoba, X5000
Novartis Investigative Site
Quilmes, Buenos Aires, B1878DKF
Novartis Investigative Site
Salta, 4400
Novartis Investigative Site
San Miguel de Tucumán, T4000NIJ
Novartis Investigative Site
Villa María, Córdoba Province, X5900JKA
France7 sites
Novartis Investigative Site
Amiens, 80054
Novartis Investigative Site
Besançon, 25030
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75012
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Tourcoing, 59200
Novartis Investigative Site
Valenciennes, 59300
Poland7 sites
Novartis Investigative Site
Bialystok, 15-276
Novartis Investigative Site
Krakow, 31202
Novartis Investigative Site
Lodz, Łódź Voivodeship, 90 549
Novartis Investigative Site
Poznan, 61-848
Novartis Investigative Site
Puławy, 24100
Novartis Investigative Site
Warsaw, 04-749
Novartis Investigative Site
Wroclaw, 50 420
Turkey (Türkiye)6 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Eskişehir, Meselik, 26480
Novartis Investigative Site
Istanbul, 34304
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Mersin, 33343
Novartis Investigative Site
Sivas, 58140
Belgium5 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Genk, 3600
Novartis Investigative Site
Huy, 4500
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Ronse, 9600
Lebanon5 sites
Novartis Investigative Site
Beirut, 1107 2020
Novartis Investigative Site
Beirut
Novartis Investigative Site
El Achrafiyé, 166830
Novartis Investigative Site
El Chouf, LBN, 1503201002
Novartis Investigative Site
Saida, 652
Canada4 sites
Novartis Investigative Site
Hamilton, Ontario, L8L 2X2
Novartis Investigative Site
Montreal, Quebec, H3A 1A1
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1M9
Italy4 sites
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Cremona, CR, 26100
Novartis Investigative Site
Milan, 20142
Novartis Investigative Site
Roma, RM, 00152
Norway4 sites
Novartis Investigative Site
Ålesund, NO-6026
Novartis Investigative Site
Bergen, 5009
Novartis Investigative Site
Grålum, 1714
Novartis Investigative Site
Lillehammer, 2629
Saudi Arabia3 sites
Novartis Investigative Site
Dammam, 31463
Novartis Investigative Site
Jeddah, 21499
Novartis Investigative Site
Riyadh, 11211
Sweden2 sites
Novartis Investigative Site
Gothenburg, 413 45
Novartis Investigative Site
Jönköping, 551 85
Switzerland2 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Geneva, 1211
About this study
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)
To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.
- Being tested
- LCZ696
- Keywords
- Acute decompensated heart failure, Reduced ejection fraction, Pre-discharge treatment, Post-discharge treatment, Angiotensin receptor neprilysine inhibitor, HFrEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ696Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-discharge treatment initiation | Other | Patients received first dose at any point after Randomization but no later than 12 h before discharge. Receives: Drug: LCZ696 |
| Post-discharge treatment initiation | Other | Patients received first dose after discharge and up to 14 days thereafter. Receives: Drug: LCZ696 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks after Randomization
Secondary outcomes (3)
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
Measured: 10 weeks after Randomization
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
Measured: 10 weeks after Randomization
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
Measured: 10 weeks after Randomization AND 26 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start12 Feb 2016
- Primary completion20 Feb 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661217
- Sponsor's protocol ID
- CLCZ696B2401
- Other IDs
- 2015-003266-87, 2015
- Acronym
- TRANSITION
- Status last verified
- Mar 2021
- First submitted
- 19 Jan 2016
- Last updated
- 26 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Straburzynska-Migaj E, Senni M, Wachter R, Fonseca C, Witte KK, Mueller C, Lonn E, Butylin D, Noe A, Schwende H, Lawrence D, Suryawanshi B, Pascual-Figal D; of TRANSITION Investigators. Early Initiation of Sacubitril/Valsartan in Patients With Acute Heart Failure and Renal Dysfunction: An Analysis of the TRANSITION Study. J Card Fail. 2024 Mar;30(3):425-435. doi: 10.1016/j.cardfail.2023.08.021. Epub 2023 Sep 9.
PubMed 37678704Pascual-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.
PubMed 32800508Senni 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.
PubMed 31820537Wachter 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.
PubMed 31134724Pascual-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.
PubMed 29239515
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02661217
- Acronym / sponsor ID
- TRANSITION / CLCZ696B2401
- Keywords
- Acute decompensated heart failure, Reduced ejection fraction, Pre-discharge treatment, Post-discharge treatment, Angiotensin receptor neprilysine inhibitor, HFrEF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-discharge treatment initiation | Other | Drug: LCZ696Patients received first dose at any point after Randomization but no later than 12 h before discharge. |
| Post-discharge treatment initiation | Other | Drug: LCZ696Patients received first dose after discharge and up to 14 days thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCZ696LCZ696 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. | Drug | Post-discharge treatment initiation, Pre-discharge treatment initiation |
Primary outcome
Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization
Time frame: 10 weeks after Randomization
Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10
3 secondary outcomes
Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid
Time frame: 10 weeks after Randomization
Percentage of Patients Achieving and Maintaining Any Dose of LCZ696
Time frame: 10 weeks after Randomization
Percentage of Patients Permanently Discontinued From Treatment
Time frame: 10 weeks after Randomization AND 26 weeks after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37678704Straburzynska-Migaj E, Senni M, Wachter R, Fonseca C, Witte KK, Mueller C, Lonn E, Butylin D, Noe A, Schwende H, Lawrence D, Suryawanshi B, Pascual-Figal D; of TRANSITION Investigators. Early Initiation of Sacubitril/Valsartan in Patients With Acute Heart Failure and Renal Dysfunction: An Analysis of the TRANSITION Study. J Card Fail. 2024 Mar;30(3):425-435. doi: 10.1016/j.cardfail.2023.08.021. Epub 2023 Sep 9.
- Derived from this study: PubMed 32800508Pascual-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.
- Derived from this study: PubMed 31820537Senni 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.
- Derived from this study: PubMed 31134724Wachter 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.
- Derived from this study: PubMed 29239515Pascual-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
152 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LCZ696 in people with Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 152 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 152 sites in Germany, United Kingdom, Spain, Czechia, Portugal and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization (time frame: 10 weeks after Randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661217, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.