Data are available from the corresponding author on reasonable request.
Novartis Pharmaceuticals was involved in the ALTITUDE trial design and protocol development, and data collection. The study sponsor was not involved in the design of this study; the collection, analysis and interpretation of data; writing the report; or the decision to submit the report for publication.
Duality of interest
JPS and BC declare that there is no duality of interest associated with this manuscript.
MAP, ASD, DdZ, SMH, JJVM, HHP, SDS and NC were members of the ALTITUDE steering committee and received funding from Novartis in relation to ALTITUDE.
MAP was a consultant to Amgen, AstraZeneca, Bayer, DalCor Pharma UK, Genzyme, Lilly, Medicines Company, MedImmune, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Salix, Sanderling, Sanofi, Takeda, Teva, Thrasos and Vericel, and has received research grant support from Amgen, Celladon, Novartis and Sanofi. The Brigham and Women’s Hospital has patents for the use of inhibitors of the renin–angiotensin system in selected survivors of myocardial infarction with Novartis Pharmaceuticals. MAP is a co-inventor and his share of the licensing agreement is irrevocably transferred to charity.
ASD has received honoraria for consulting or advisory board participation from Janssen, Sanofi, Merck, St Jude Medical, AstraZeneca, and Relypsa. ASD reports grants and personal fees from Novartis during the conduct of the study; and personal fees from St Jude Medical, Relypsa, Janssen, Sanofi, Merck and AstraZeneca outside the submitted work.
DdZ’s employer, University Medical Center Groningen, was paid by the following companies (trials) for time spent: AbbVie (RADAR, SONAR), Astellas, Astra Zeneca (PLANET-I, PLANET-II), Bayer, Boehringer Ingelheim, Fresenius, Janssen (CANVAS, CANVAS-R, CREDENCE), Novartis (ALTITUDE).
JJVM’s employer, University of Glasgow, was paid by following companies (trials) for time spent: Cardiorentis (TRUE-AHF trial), Amgen (ATOMIC-HF and COSMIC-HF), Novartis (ATMOSPHERE, PARADIGM-HF, PARAGON-HF, PARADISE-MI), Oxford University/Bayer (ACE trial), GlaxoSmithKline (Harmony-Outcome trial, ASCEND-D and ASCEND-ND), Theracos (BEST trial), Abbvie (SONAR trial), DelCor (Dal-GenE trial), Pfizer (SPIRE trial), Merck (MK-3102 programme and for the VICTORIA trial Merck), AstraZeneca (planning a new clinical trial using dapagliflozin in heart failure), Bristol Myers Squibb planning a new clinical trial (using an HNO donor), and Kidney Research UK/Kings College Hospital, London/Vifor-Fresenius Pharma. JJNM reports other grants from Novartis, Cardiorentis, Amgen, Novartis, Oxford University/Bayer, GlaxoSmithKline, Theracos, Abbvie, DalCor, Pfizer, Merck, AstraZeneca, Bristol Myers Squibb, and Kidney Research UK/Kings College Hospital, London/Vifor-Fresenius Pharma outside the submitted work.
SDS reports research grants/consulting fees for Amgen, AstraZeneca, Sanofi, AstraZeneca, GlaxoSmithKline, and Gilead; previous consultation with Bristol Myers Squibb and Theracos; advisory board participation for Merck, and Roche; and research with Ionis.
NC receives payments from AstraZeneca in compensation for work as a member of a data safety and management board for a clinical trial.
All authors contributed to the interpretation of the results, writing or revision of the manuscript, and approved the decision to submit the article for publication. The data analysis was done by the academic authors (MAP, BC and JPS) at Brigham and Women’s Hospital. MAP is the guarantor of this work.