heart failure
Conditions
Interventions
Intervention Group:Not using quadruple therapy:
Symptom guided treatment group: As long as there are no obvious symptoms of hypotension and the systolic blood pressure remains above 80mmHg, try gradua
If the patient does not experience frequent hypotension symptoms (= 2 times per week), the medication should not be lowered or stopped.
Four combination therapy has been used:
Symptom guided treatment
If the patient does not experience frequent new symptoms of hypotension (= 2 times per week), the medication should not be lowered or stopped
Control Group:Not using quadruple therapy:
Blood pressure guided treatment group: Only when the systolic blood pressure is greater than 100mmHg, try adding the type of medication to low-dose quadruple
Sponsors
Xinqiao Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Provide signed informed consent form 2) Age greater than or equal to 18 years old 3) Meet the criteria for chronic symptomatic heart failure and have been diagnosed for at least 2 months: 4) New York Heart Association (NYHA) grades II-IV, with a left ventricular ejection fraction (LVEF) below 40% (within the previous year, the most recent time, or within the last 3 months if heart failure treatment has been performed) 5) According to the local laboratory, NT proBNP elevation = 600 pg/mL (or = 400 pg/mL if hospitalized for heart failure in the past 12 months, or = 900 pg/mL if atrial fibrillation/flutter is present) 6) If the systolic blood pressure is between 85-100mm Hg, and if it is between 100-110mm Hg, an average systolic blood pressure of 85-100mm Hg in the previous 3 months will still be included 7) There are no contraindications (such as serum potassium = 5.0 mEq/L (mmol/L) within 24 hours) and allergies, and at least one of the recommended quadruple heart failure treatment regimens (ACEi/ARB/ARNi; ß - block; MRA and sGLT2i) has not reached 50% of the target dose, and the dose has been stable for at least 4 weeks. 8) eGFR =30 ml/min/1.73 m2
Exclusion criteria
Exclusion criteria: 1) Excluding advanced heart failure, according to the National Heart Failure Guidelines 2023, it is defined as a diagnosis that must simultaneously meet the following criteria under optimized GDMT, instrumentation, or surgical treatment a) There are severe progressive or persistent symptoms of heart failure (NYHA functional class III or IV) present b) There is severe cardiac dysfunction that meets at least one of the following criteria: i. LVEF = 30%; Ii. Isolated right heart failure; Iii. There is severe valvular heart disease that cannot be surgically treated; Iv. Severe congenital heart disease that cannot be surgically treated; v. LVEF = 40%, Continuous increase in levels of natriuretic peptide (or higher than before), evidence of severe diastolic dysfunction or left ventricular structural abnormalities c) More than 1 unplanned outpatient or emergency visit or hospitalization occurred within the past year due to the following reasons: i. Pulmonary or systemic congestion requires high-dose intravenous diuretics or diuretic combination therapy; Ii. Hypotension caused by decreased cardiac output requires the use (or dependence) of positive inotropic or vasoactive drugs; Iii. Malignant arrhythmia d) It is estimated that severe impairment of activity tolerance caused by cardiac reasons leads to inability to exercise, or a 6-minute walking distance of less than 300 meters, or peak oxygen consumption indicated by cardiopulmonary exercise tests of less than 12-14 ml/(kg · min) or less than 50% of the expected value 2) Cardiogenic shock 3) Organ hypoperfusion is defined as simultaneously meeting the following four criteria a) Decreased mental state b) Cold limbs, reticular edema c) Urine output2 mmol/L 4) Frequent (= once a week) symptoms of hypotension: including but not limited to dizziness, fatigue, especially when standing and standing upright, or diagnosed with orthostatic hypotension. 5) There are contraindications for quadruple heart failure drugs (such as serum potassium = 5.0 mEq/L (mmol/L) within 24 hours) or allergies. 6) Previous high-dose new quadruple therapy with titration resulted in intolerance (including symptomatic hypotension, but not including simple hypotension). 7) Low blood pressure caused by known uncorrected reasons (fever, diarrhea, other new drugs, dehydration, etc.) 8) Hospitalization due to heart failure within 4 weeks 9) Accept intravenous injection of cardiac stimulants (such as dobutamine, milrinone, levosimendan) or intravenous injection of vasopressors (such as adrenaline, norepinephrine, dopamine, or vasopressin) 10) Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), myocardial infarction or other cardiovascular events, cardiovascular surgery, or those with clear indications for cerebrovascular disease surgery within the past 90 days 11) Suffering from severe primary liver disease (ALT or AST greater than 3 times the upper bound, total bilirubin greater than 2 times the upper bound) 12) During screening, the electrocardiogram records atrial fibrillation or atrial flutter with a resting heart rate greater than 110 bpm 13) Breastfeeding, pregnancy (including expectations) 14) Researchers believe that comorbidities, physical injuries, mental conditions, or the inability to complete all required study visits or procedures and/or comply with all required study procedures may interfere with the conduct of the study (including outcome evaluation). 15) Malign
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compared to baseline, the heart failure marker NT proBNP decreased by 30% within one month.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compared to baseline, changes in left ventricular ejection fraction (LVEF), KCCQ-TSS, symptomatic hypotension, worsening of heart failure for the first time (readmission to heart failure, emergency heart failure visit), or cardiovascular death events within one month, with improvement of KCCQ-TSS by = 10 points after treatment.; | — |
Countries
China
Contacts
Public ContactJing-Wei Li
Xinqiao Hospital
Outcome results
None listed