Pulmonary REsistance Modification Under Treatment With Sacubitril/valsartaN in paTients With Heart Failure With Reduced Ejection Fraction

Summary

MAIN OBJECTIVE. Demonstration that use of sacubitril/valsartan influences parameters of right heart catheterization, including pulmonary artery pressure, and provokes changes in pulmonary circulation resistance in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and post-capillary pulmonary hypertension (PH): both isolated post-capillary (Ipc-PH) and combined post- and pre-capillary (Cpc-PH), which we predict could improve prognosis in this group of patients.

RESEARCH HYPOTHESIS. Sacubitril/valsartan used in patients with HFrEF accompanied by pulmonary hypertension due to HFrEF will reduce pulmonary artery pressure, pulmonary vascular resistance, and the incidence of secondary end-points as listed in the protocol.

STUDY OUTLINE. PRESENT-HF will show the effects of sacubitril/valsartan on pulmonary circulation pressure in patients with HFrEF and post-capillary pulmonary hypertension (PH): both isolated post-capillary (Ipc-PH) and combined post- and pre-capillary (Cpc-PH), which is expected to improve prognosis.

Conditions

• Heart Failure

Interventions

DRUG

Sacubitril-valsartan

level 1-24 / 26mg 2 times a day, level 2-49 / 51mg 2 times a day, level 3-97 / 103mg 2 times aday

DRUG

Enalapril

level 1-2.5 mg twice a day, level 2-5 mg twice a day, level 3-10 mg twice a day

DRUG

placebo

placebo matching for 24 / 26mg, 49 / 51mg, 97 / 103mg 2 of sacubitril/valsartan

DRUG

Placebo

placebo matching for 2.5 mg, 5 mg, 10 mg of enalapril

Sponsors & Collaborators

• Medical Research Agency, Poland

  collaborator OTHER_GOV

• Medical University of Bialystok

  collaborator OTHER

• University of Opole

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Medical University of Silesia

  collaborator OTHER

• Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań

  lead OTHER

Principal Investigators

• Ewa Straburzyńska-Migaj, Prof. MD · University Hospital in Poznan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-13

Primary Completion

2025-02-28

Completion

2025-11-30

Countries

• Poland

Study Locations