Pulmonary Resistance Modification under treatment with Sacubitril/valsartan in Patients with Heart Failure with reduced ejection fraction (PRESENT-HF) - Study protocol and rationale for a multicentre randomised controlled trial

Ewa  Straburzyńska-Migaj; Magdalena Dudek; Jacek  Migaj; Agnieszka Bartczak-Rutkowska; Jarosław  Hiczkiewicz; Piotr  Cygański; Agnieszka Tycińska; Marek Gierlotka; Ewa  Kozielska-Nowalany; Jacek  Kubica; Małgorzata  Tomaszewska; Piotr  Sawiński; Lech  Paluszkiewicz; Maciej  Lesiak; Marta Kałużna-Oleksy

doi:10.20883/medical.e1332

Authors

Ewa Straburzyńska-Migaj 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland https://orcid.org/0000-0002-0545-3370
Magdalena Dudek 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland https://orcid.org/0000-0001-6550-6182
Jacek Migaj 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland https://orcid.org/0000-0002-7962-3934
Agnieszka Bartczak-Rutkowska 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland https://orcid.org/0000-0002-6607-9191
Jarosław Hiczkiewicz Clinical Department of Cardiology, Nowa Sól Multidisciplinary Hospital, Nowa Sól, Poland https://orcid.org/0000-0002-1111-3372
Piotr Cygański Department of Internal Medicine and Cardiology, City Hospital, Olsztyn, Poland https://orcid.org/0000-0003-0698-6651
Agnieszka Tycińska Department of Cardiology, Medical University of Bialystok, Białystok, Poland https://orcid.org/0000-0001-7855-7261
Marek Gierlotka Department of Cardiology, University Hospital, Institute of Medical Sciences, University of Opole, Opole, Poland https://orcid.org/0000-0001-5639-2128
Ewa Kozielska-Nowalany II Department of Cardiology in Zabrze, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland https://orcid.org/0000-0002-5977-513X
Jacek Kubica Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland https://orcid.org/0000-0001-8250-754X
Małgorzata Tomaszewska 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland https://orcid.org/0009-0006-7343-1401
Piotr Sawiński 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland
Lech Paluszkiewicz Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Centre North-Rhine Westphalia, Ruhr-University of Bochum, Bad Oeynhausen, Germany https://orcid.org/0000-0002-9095-1277
Maciej Lesiak 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland https://orcid.org/0000-0003-2630-5016
Marta Kałużna-Oleksy 1st Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland https://orcid.org/0000-0003-4048-6247

DOI:

https://doi.org/10.20883/medical.e1332

Keywords:

HFrEF, ARNI, sacubitril/valsartan, pulmonary hypertension, pulmonary hypertension due to left heart disease

Abstract

Introduction. Heart failure with reduced ejection fraction (HFrEF) remains a major clinical challenge, partly due to suboptimal implementation of guideline-directed medical therapy and complications such as pulmonary hypertension (PH) that worsen symptoms and prognosis.

Material and methods. PRESENT-HF (ClinicalTrials.gov Identifier: NCT05487261, https://clinicaltrials.gov/ct2/show/NCT05487261) is a multicenter, randomised, double-blind, comparator-controlled clinical trial investigating whether sacubitril/valsartan, compared to enalapril, lowers pulmonary artery pressure and pulmonary vascular resistance as measured by right heart catheterisation in patients with HFrEF and secondary PH. The study will recruit approximately 230 patients, with a 1:1 randomisation to either sacubitril/valsartan or enalapril, and a 52-week follow-up that includes both in-hospital and out-of-hospital treatment phases.

Results. The primary endpoint is the change from baseline in mean pulmonary artery pressure and pulmonary vascular resistance; secondary outcomes include clinical events, quality of life, functional capacity, and safety.

Conclusions. This trial will offer new insights into targeted strategies for improving outcomes in patients with HFrEF complicated by PH, potentially expanding treatment options and informing future guidelines.

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