Heart Failure and Low Blood Pressure
Conditions
Interventions
Placebo control group:Administer placebo of vericiguat
Sponsors
Chinese Academy of Medical Sciences Fuwai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years and 300 pg/ml (without atrial fibrillation); NT-proBNP > 450 pg/ml (with atrial fibrillation); (3) NYHA functional class II–IV; (4) Receiving guideline-recommended pharmacotherapy with stable dosage for >=4 weeks, with daily ARNI dose <200 mg and daily ß-blocker dose <100 mg. 3. Systolic blood pressure 85 mmHg = SBP = 100 mmHg at baseline before randomization.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1. Receiving mechanical hemodynamic support, invasive mechanical ventilation or hemofiltration within 5 days prior to randomization; administration of intravenous vasodilators, intravenous inotropic agents or vasoactive drugs within 12 hours before random grouping. 2. Poorly controlled hypertension, defined as resting systolic blood pressure =180 mmHg and/or diastolic blood pressure >=110 mmHg confirmed by two separate examinations prior to randomization. 3. Estimated glomerular filtration rate <15 ml/min/1.73m². 4. Hemoglobin <=9 g/dL, or patients with hematological diseases. 5. Unoperated valvular heart disease or congenital heart disease. 6. Cardiogenic shock. 7. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, and other secondary or infiltrative cardiomyopathies. 8. Active myocarditis. 9. Constrictive pericarditis and other pericardial diseases. 10. Syncope history within 3 months. 11. Symptomatic bradycardia, second-degree or third-degree atrioventricular block without pacemaker implantation. 12. Malignant ventricular arrhythmia affecting hemodynamics. 13. Implantation of CRT-P or CRT-D within 6 months, upgrade of conventional pacemaker or ICD to CRT device within 6 months, or planned implantation of similar devices within 6 months. 14. Stroke within 3 months; major cardiovascular surgery or other major surgery within 3 months; percutaneous coronary intervention (PCI), valvular intervention or other interventional procedures within 1 month; planned revascularization (PCI or CABG), valvular intervention or other major surgery within the next 3 months. 15. Major surgical operation within 6 months prior to randomization. 16. History of heart transplantation or left ventricular assist device (LVAD) implantation, waiting for heart transplantation, or planned LVAD implantation. 17. Severe chronic obstructive pulmonary disease, cor pulmonale, severe pulmonary vascular disease, pulmonary hypertension secondary to autoimmune diseases, or severe pulmonary hypertension of any etiology. 18. History of major organ transplantation including lung, liver, heart, bone marrow and kidney transplantation. 19. Complicated with severe primary diseases of liver, kidney, hematopoietic system, nervous system, endocrine system, malignant tumors or mental disorders. 20. Life expectancy <1 year. 21. Known allergy to any study drug. 22. Participation in other clinical drug trials within 1 month. 23. Inability to discontinue traditional Chinese medicine preparations with related ingredients, including Danshen Injection, Guanxinning Injection, Shuxuening Injection, Ligustrazine Powder for Injection, Ginkgo Leaf Extract Preparation, Shexiang Baoxin Pill, Suxiao Jiuxin Pill, Ligustrazine Hydrochloride for Injection, Danshen Ligustrazine Injection, Compound Xueshuantong Capsule, Xueshuantong Injection, Qili Qiangxin Capsule, Shenmai Drink, Shenmai Injection, Gualou Tablets, as well as traditional Chinese decoctions and hospital proprietary TCM preparations containing ginseng, American ginseng, panax notoginseng and panax japonicus. 24. Pregnancy (positive pregnancy test), lactation, or women of childbearing age without adequate contraceptive measures. 25. Patients judged by investigators to be unable to complete the study or comply with study requirements due to administrative or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in left ventricular ejection fraction (LVEF) from baseline at day 90;Changes in 6-minute walk distance from baseline at day 90; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90-day composite heart failure endpoint (all-cause mortality, total heart failure rehospitalizations, first heart failure rehospitalization, heart failure deterioration, changes in KCCQ-CSS score from baseline, changes in LVEF from baseline, NT-proBNP reduction >30% from baseline);Cardiovascular death and heart failure rehospitalization;Cardiovascular death or first heart failure rehospitalization;All-cause death and heart failure rehospitalization;Cardiovascular death;All-cause death;Heart failure rehospitalization;All-cause death or first heart failure rehospitalization;Cardiovascular death, heart failure rehospitalization and heart failure deterioration;All-cause death, heart failure rehospitalization and heart failure deterioration;18F-1799 PET cardiac sympathetic neuroimaging at day 90 and day 180;Changes in left ventricular ejection fraction (LVEF) from baseline at day 180;Proportion of patients with LVEF>45% and LVEF>50% at day 90 and day 180;Changes in 6-minute walk distance from baseline at day 180;Changes in NT-proBNP from baseline at day 90 and day 180;NT-proBNP reduction >30% from baseline at day 90 and day 180;Changes in KCCQ-CSS score from baseline at day 90 and day 180;Changes in EQ-5D-5L score (health utility value, VAS) from baseline at day 90 and day 180;NYHA cardiac functional classification at day 90 and day 180; | — |
Countries
China
Contacts
Public ContactYuhui Zhang
Chinese Academy of Medical Sciences Fuwai Hospital
Outcome results
None listed