Trial DesignRationale and methods of the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure (PROVE-HF)
Graphical abstract
X = vital status/events (CV death, HF hospitalization, worsening HF), physical examination, blood sampling, urine sampling, HF symptom assessment, KCCQ-23.
*Standard HF therapy is continued throughout the study. †At day 45, KCCQ-23 was not administered.
At selected sites, samples will be collected in protease inhibitor tubes at each timepoint (n = 180).
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RCT# NCT02887183
Conflicts of interest
James L. Januzzi: grant support from Roche Diagnostics, Siemens, Cleveland Heart Labs, and Prevencio, consulting income from Roche Diagnostics, Abbott, Phillips, and Novartis; and participates in clinical end point committees/data safety monitoring boards for AbbVie, Bayer, Pfizer, Novartis, Amgen, Janssen, and Boehringer-Ingelheim.
Javed Butler: consultant for Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, BMS, CVRx, Medtronic, Novartis, Relypsa, and ZS Pharma.
Emmanuel Fombu: employee, Novartis Pharmaceuticals Corporation.
Alan Maisel: consultant for Critical Diagnostics and Alere; research support from Norvartis and Roche.
Kevin McCague: employee, Novartis Pharmaceuticals Corporation.
Ileana L. Piña: nothing to declare.
Margaret F. Prescott: employee, Novartis Pharmaceuticals Corporation.
Jerome B. Riebman: employee, Novartis Pharmaceuticals Corporation.
Scott Solomon: consultant for Novartis; research grant from Novartis through academic institution.
All authors have approved the final article for submission to the journal.