Heart failure
Conditions
Interventions
Treatment group:vericiguat 10mg q.d po
Control group :vericiguat 5mg q.d po
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and be aged >= 18 years; 2. Meet the guideline-defined criteria for chronic heart failure, and have left ventricular ejection fraction (LVEF) = 130 mmHg and = 30 mL/min/1.73 m^2 at screening (calculated using the CKD-EPI equation); 6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) level > 300 pg/mL (sinus rhythm) or > 900 pg/mL (atrial fibrillation) at screening.
Exclusion criteria
Exclusion criteria: 1. History of symptomatic hypotension or syncope within 4 weeks before randomization; 2. Current use or planned long-term use of other soluble guanylate cyclase (sGC) stimulators; 3. Within 4 weeks before randomization: acute myocardial infarction, unstable angina, stroke, transient ischemic attack; or undergoing major cardiovascular surgery via thoracotomy/laparotomy; or percutaneous coronary intervention within 90 days; 4. Requirement for long-term or intermittent use of long-acting nitrates or phosphodiesterase type 5 inhibitors; 5. Known hypersensitivity to vericiguat or any of its excipients; 6. Severe hepatic impairment (e.g., Child-Pugh Class C) or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN); 7. Pregnant or lactating women; women of childbearing potential/men unwilling to use highly effective contraception during the study; 8. Participation in any other interventional clinical trial within 30 days before randomization; 9. Any condition that, in the investigator’s opinion, may interfere with study assessments, compromise subject safety, or reduce compliance (e.g., life expectancy < 1 year, drug or alcohol abuse, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic hypotension;Incidence of syncope;Incidence of composite tolerability failure events; | — |
Countries
China
Contacts
Public ContactWang Yushi
The First Hospital of Jilin University
Outcome results
None listed