Vericiguat on Heart Failure with reduced Ejection Fraction with Pulmonary Hypertension

JRCT ID: jRCT1051230206

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HFrEF: heart failure with reduced ejection fraction
• Date of first enrollment: 15/03/2024
• Target sample size: 35
• Study type: Interventional
• Intervention(s): The dose of Vericiguat should be started at 2.5 mg and gradually increased to 5 mg and 10 mg at 2-week intervals, and the dose should be reduced according to blood pressure and other patient conditions. The protocol treatment period is 16 weeks from the start of administration of Vericiguat.

Outcome(s)

• Primary Outcome: Change in pulmonary vascular resistance (PVR)

Secondary Outcome

1) Change in cardiac index (CI)
2) Change in mean pulmonary artery pressure (mPAP)
3) Change in NT-proBNP

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients must meet all of the following criteria at the time of consent.
1) Left ventricular ejection fraction (LVEF) less than 40% on echocardiography performed within 12 months.
2) Patients must be on standard treatment for chronic heart failure, with stable doses within 1 week before catheterization and during the screening period before enrollment.
3) Patients with combined post- and pre-capillary pulmonary hypertension (CpcPH: mean pulmonary artery pressure > 20 mmHg, pulmonary wedge pressure > 15 mmHg, pulmonary vascular resistance > 160 dynes-sec-cm-5) at a right heart catheterization performed within 28 days.
4) Patients must be at least 18 years of age (as of the date written consent is obtained).
5) Written consent has been obtained from the patient before enrollment.

Exclude criteria

Patients must not be in conflict with any of the following criteria at the time consent is obtained.
1) Patients with a clinically unstable condition at the time of enrollment as defined below
a) Received an intravenous therapeutic agent within 24 hours, or
b) Systolic blood pressure less than 100 mmHg or symptomatic hypotension.
2) Patients who must receive concomitant long-acting nitrates or NO donors.
3) Patients requiring use of phosphodiesterase 5 inhibitors.
4) Patients requiring use of other pulmonary vasodilators (endothelin receptor antagonists, prostacyclines, prostacyclin receptor agonists).
5) Patients requiring use of other sGC stimulants.
6) Patients with known allergy or hypersensitivity to sGC stimulants.
7) Patients awaiting heart transplantation, receiving continuous intravenous inotropic infusion, or who have or will have a ventricular assist device implantation.
8) Patients with acute coronary syndrome within 60 days before enrollment or patients who have undergone coronary revascularization within 60 days before enrollment.
9) Patients with serious complications (severe liver dysfunction such as hepatic encephalopathy, patients with severe pulmonary disease requiring continuous home oxygenation, eGFR less than 15 mL/min/1.73 m2 or patients undergoing dialysis, patinets with life expectancy less than 6 months due to malignancy or extra-cardiac disease).
10) Pregnant or lactating women, or women of childbearing potential (within 12 months of last menstrual period) who are unable to consent to contraception during the study period.
11) Patients who plans to participate in a study involving another intervention during the study period.
12) Patients who plans to undergo catheter intervention or surgery during the study period after enrollment.
13) For other safety reasons, the principal investigator or subinvestigator determines that participation in this study is inappropriate.

Related Information

• Primary Sponsor: Matoba Satoaki