Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
NCT ID: NCT02661217
Last Updated: 2021-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1002 participants
INTERVENTIONAL
2016-02-12
2018-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Pre-discharge treatment initiation
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
LCZ696
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.
Post-discharge treatment initiation
Patients received first dose after discharge and up to 14 days thereafter.
LCZ696
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.
Interventions
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LCZ696
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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
3. Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
4. Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
5. 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
2. Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
3. End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
4. Serum potassium above 5.4 mmol/L at Randomization.
5. Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
6. Severe hepatic impairment, biliary cirrhosis and cholestasis
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Quilmes, Buenos Aires, Argentina
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Villa María, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Salta, , Argentina
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San Miguel de Tucumán, , Argentina
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Brussels, , Belgium
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Genk, , Belgium
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Huy, , Belgium
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Leuven, , Belgium
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Ronse, , Belgium
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Brno, Czech Republic, Czechia
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Karlovy Vary, Czech Republic, Czechia
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Liberec, Czech Republic, Czechia
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Tábor, Czech Republic, Czechia
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Třebíč, Czech Republic, Czechia
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Beroun, CZE, Czechia
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Ostrava, CZE, Czechia
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Brno Bohunice, , Czechia
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Jihlava, , Czechia
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Kolín, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Slaný, , Czechia
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Amiens, , France
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Besançon, , France
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Paris, , France
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Paris, , France
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Toulouse, , France
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Tourcoing, , France
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Valenciennes, , France
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Mannheim, Baden-Wurttemberg, Germany
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Regensburg, Bavaria, Germany
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Leverkusen, North Rhine-Westphalia, Germany
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Berlin, , Germany
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Dortmund, , Germany
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Erfurt, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Jena, , Germany
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Koeln-Nippes, , Germany
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Langen, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Mönchengladbach, , Germany
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Neuwied, , Germany
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Oldenburg, , Germany
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Rüsselsheim am Main, , Germany
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Witten, , Germany
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Bergamo, BG, Italy
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Cremona, CR, Italy
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Roma, RM, Italy
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Milan, , Italy
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El Chouf, LBN, Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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El Achrafiyé, , Lebanon
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Saida, , Lebanon
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Ålesund, , Norway
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Bergen, , Norway
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Grålum, , Norway
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Lillehammer, , Norway
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Bialystok, , Poland
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Krakow, , Poland
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Puławy, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Lodz, Łódź Voivodeship, Poland
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Vila Real, Portuigal, Portugal
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Gatchina, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Dammam, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Dunajská Streda, Slovak Republic, Slovakia
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Košice, Slovak Republic, Slovakia
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Liptovský Mikuláš, Slovak Republic, Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Dolný Kubín, , Slovakia
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Martin, , Slovakia
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Prešov, , Slovakia
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Rimavská Sobota, , Slovakia
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Trnava, , Slovakia
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Málaga, Andalusia, Spain
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Sanlúcar de Barrameda, Andalusia, Spain
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Seville, Andalusia, Spain
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Seville, Andalusia, Spain
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Barcelona, Barcelona/ Cataluny/Espanya, Spain
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Villamartín, Cadiz, Spain
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A Coruña, Galicia, Spain
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Olot, Girona, Spain
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Móstoles, Madrid, Spain
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El Palmar, Murcia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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Jönköping, , Sweden
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Basel, , Switzerland
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Geneva, , Switzerland
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Eskişehir, Meselik, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Sivas, , Turkey (Türkiye)
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Westcliff-on-Sea, Essex, United Kingdom
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Basingstoke, Hampshire, United Kingdom
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Ashford, Kent, United Kingdom
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Bridgend, Mid Glamorgan, United Kingdom
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Portadown, Nothern Ireland, United Kingdom
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Sunderland, Tyne and Wear, United Kingdom
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Blackpool, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Middlesbrough, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Norwich, , United Kingdom
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Swindon, , United Kingdom
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York, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003266-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCZ696B2401
Identifier Type: -
Identifier Source: org_study_id
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