Goal-directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study

Phase 1

• Conditions: acute decompensated heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-004977-10-BG
• Lead Sponsor: niversity Hospital Basel, Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-15
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 770

Inclusion Criteria

- patients with acute heart failure
- age > 18 years
- signed informed consent
- negative pregnancy test (only in female patients = 60 years)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550

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 mm Hg 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 heart failure
- hypertrophic obstructive cardiomyopathy
- chronic kidney disease with creatinine levels > 250 µmol/l
- bilateral renal artery stenosis
- severe sepsis or other causes of high output failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of our study is to determine the safety and efficacy of an early goal-directed preload and afterload decrement with a target systolic blood pressure of 90-110 mm Hg by aggressive vasodilatation versus standard medical care in a non-ICU setting in patients with acute heart failure;Primary end point(s): - death or heart failure rehospitalisation within 180 days;Timepoint(s) of evaluation of this end point: - 90 days, 180 days and 360 days after enrollment;Secondary Objective: Predefined subgroup analyses will be performed in patients < or > 75 years of age, men and women, systolic (LVEF < 45%) heart failure and heart failure with preserved LVEF, systolic blood pressure at presentation < or > 140 mm Hg, coronary artery disease present or not, BNP levels < or > 1000 pg/ml and isolated or concurrent right heart failure