Phase
Condition
Chest Pain
Congestive Heart Failure
Inflammation
Treatment
Prednisone
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 85 years of age
Unplanned ED visit or hospital presentation within the 12 hours prior to Screeningwith acute or worsening dyspnea and/or orthopnea, and pulmonary congestion on chestX-ray or lung ultrasound.
All measures from presentation to randomization of systolic blood pressure ≥ 100mmHg, and of heart rate ≥ 60 bpm.
Written informed consent to participate in the study.
Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP > 1,500 pg/mL and CRP > 20 mg/L
Patient agrees for follow-up visits at the hospital at day 7 in case of earlierdischarge and Day 31.
Exclusion
Exclusion Criteria:
Anticipated life expectancy less than 6 months
Mechanical ventilation (not including CPAP/BIPAP) prior to Screening.
Significant pulmonary disease contributing substantially to the patients' dyspneasuch as FEV1< 1 liter or need for chronic systemic or non-systemic steroid therapy,or any kind of primary right heart failure such as primary pulmonary hypertension orrecurrent pulmonary embolism.
Myocardial infarction, unstable angina or cardiac surgery within 3 months, orcardiac resynchronization therapy (CRT) device implantation within 3 months, orpercutaneous transluminal coronary intervention (PTCI), within 1 month prior toinclusion.
Index Event (admission for AHF) triggered primarily by a correctable etiology suchas significant arrhythmia (e.g., sustained ventricular tachycardia, or atrialfibrillation/flutter with sustained ventricular response >130 beats per minute, orbradycardia with sustained ventricular arrhythmia <45 beats per minute), infection,severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD,planned admission for device implantation or severe non-adherence leading to verysignificant fluid accumulation prior to admission and brisk diuresis afteradmission. Troponin elevations without other evidence of an acute coronary syndromeare not an exclusion.
Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophicobstructive cardiomyopathy.
History of heart transplant or on a transplant list, or using or planned to beimplanted with a ventricular assist device.
Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior toscreening that is untreated.
Presence at screening of any hemodynamically significant valvular stenosis orregurgitation, except mitral or tricuspid regurgitation secondary to leftventricular dilatation, or the presence of any hemodynamically significantobstructive lesion of the left ventricular outflow tract.
Primary liver disease considered to be life threatening
Renal disease or eGFR < 30 or > 80 mL/min/1.73m2 (as estimated by the simplifiedMDRD formula) at inclusion or history of dialysis.
Systemic steroid therapy, within 30 days from inclusion.
Inability to consent, or patient under guardianship measure
Participation in another intervention trial in the past 30 days
Anticipated non-adherence to study protocol or follow-up.
Pregnant or nursing (lactating) women.
Known hypersensitivity to steroids or constituents of prednisone tablets (excipients)
Psychotic states not yet controlled by treatment
Concomitant administration of live vaccines and up to 3 months after end ofcorticotherapy administration.
Patient under legal protection measure (tutorship or curatorship) and patientdeprived of freedom
Persons subject to psychiatric care without their consent
Study Design
Study Description
Connect with a study center
"Armenia" Republican Medical Center
Yerevan,
ArmeniaActive - Recruiting
"Mikaelyan" Surgery Institute
Yerevan,
ArmeniaSite Not Available
Erebouni Medical Center
Yerevan,
ArmeniaActive - Recruiting
"Armenia" Republican Medical Center
Yerevan 616052,
ArmeniaSite Not Available
"Mikaelyan" Surgery Institute
Yerevan 616052,
ArmeniaSite Not Available
Erebouni Medical Center
Yerevan 616052,
ArmeniaSite Not Available

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