Goal-directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study (GALACTIC)
Acute Heart Failure
About this trial
This is an interventional treatment trial for Acute Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Acute HF expressed by acute dyspnea New York Heart Association (NYHA) class III or IV, and a BNP-level ≥ 500 pg/ml. The diagnosis of acute HF is additionally based on typical symptoms and clinical findings, supported by appropriate investigations such as ECG, chest X-ray, and Doppler-echocardiography as recommended by current ESC guidelines on the diagnosis and treatment of acute HF
Exclusion Criteria:
- Cardiopulmonary resuscitation < 7 days
- Cardiogenic shock, ST-elevation myocardial infarction, or other clinical conditions that require immediate ICU admission or urgent PTCA
- Systolic blood pressure lower than 100 mmHg at presentation
- Primary rhythmogenic cause of acute decompensation (ventricular tachycardia, reentry tachycardia, atrial fibrillation or atrial flutter with a ventricular rate exceeding 140 beats per minute)
- NSTEMI as primary diagnosis
- Severe aortic stenosis
- Adult congenital heart disease as primary cause of acute HF
- Hypertrophic obstructive cardiomyopathy
- Chronic kidney disease with creatinin levels > 250 µmol/l
- Bilateral renal artery stenosis
- Severe sepsis or other causes of high output failure
- Cirrhosis of the liver CHILD class C
- Previous adverse reactions to nitrates
Sites / Locations
- Hospital Sao Paolo
- 5-th Multifunctional Hospital for Active Treatment
- National Transport Hospital "Tsar Boris III"
- University Hospital "Tsaritsa Joanna-ISUL"
- University Hospital Mainz
- Nuremberg Hospital
- Hospital Universitari Germans Trias i Pujol
- Hospital de la Santa Creu i Sant Pau
- University Hospital Basel
- Kantonsspital Aarau
- Kantonsspital Luzern
- Kantonsspital St. Gallen
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard of care
Intervention
Standard of care of acute decompensated heart failure will be according to the current guidelines of the European Society of Cardiology (ESC).
Early goal-directed preload and afterload decrement using a fixed therapy schedule including sublingual or nitrospray and transdermal nitrates together with hydralazine, followed by rapid up-titration of ACE-inhibitors , AT-receptor blockers or neprilysin inhibitors/AT-receptor blockers to achieve maximal vasodilatation with a target systolic blood pressure of 90-110 mmHg. All other elements of treatment will be according to the current guidelines of the European Society of Cardiology (ESC)