Acute Heart Failure
Conditions
Interventions
Product Name: different combinations of full optimal doses of beta-blockers, ACEi/ARB/ARNi, and a MRA
Pharmaceutical Form:
Sponsors
Heart Initiative
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospital admission within 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation. 2. All measures within 24 hours prior to Randomization of systolic blood pressure = 100 mmHg, and of heart rate = 60 bpm. 3. All measures within 24 hours prior to Randomization of serum potassium = 5.0 mEq/L (mmol/L). 4. Biomarker criteria for persistent congestion: a. At Screening, NT-proBNP > 2,500 pg/mL. b. At the time of Randomization (1-2 days prior to discharge), NT-proBNP > 1,500 pg/mL (to ensure the persistence of congestion) that has decreased by more than 10% compared to Screening (to ensure the acuity of the index episode). 5. At 1 week prior to admission, at Screening, and at Visit 2 (just prior to Randomization) either (a) =65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: 1. Age 85 years. 2. Clearly documented intolerance to high doses of beta-blockers. 3. Clearly documented intolerance to high doses of RAS blockers (both ACEi and ARB). 4. Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening. 5. Significant pulmonary disease contributing substantially to the patients’ dyspnea such as FEV1130 beats per minute, or bradycardia with sustained ventricular arrhythmia 14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge. 19. Inability to comply with all study requirements, due to major comorbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient’s ability to understand and/or comply with the protocol instructions or follow-up procedures 20. Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to assess the effects of optimization of medical therapy with beta-blocker; ACEi, ARB or ARNi; and MRAs on 180-day all-cause mortality or heart failure readmission in patients admitted with acute heart failure and clinical and biological signs of congestion. ;Secondary Objective: Secondary Objectives: The secondary objectives are to assess the effect of such intervention on change in quality of life (QoL) as measured by the EQ- 5D questionnaire, 180-day all-cause mortality, and 90-day all-cause mortality or heart failure readmission.;Primary end point(s): 180-day all-cause mortality or HF readmission;Timepoint(s) of evaluation of this end point: 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in quality of life measured by the EQ-5D questionnaire from randomization to day 90 2. 180-day all-cause mortality 3. 90-day all-cause mortality or heart failure readmission;Timepoint(s) of evaluation of this end point: 180 day and 90 days | — |
Countries
Argentina, Austria, Colombia, Croatia, Mozambique, Nigeria, Russian Federation, South Africa, United States
Contacts
Public ContactLibor Gajda
August Research
Outcome results
None listed