Effect of Short-term Prednisone Therapy on C-reactive Protein in Patients With Acute Heart Failure

Last updated: January 22, 2024
Sponsor: Heart Initiative
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Hyponatremia

Congestive Heart Failure

Treatment

Prednisone

Clinical Study ID

NCT05916586
CHF202301
  • Ages 18-85
  • All Genders

Study Summary

This is a multicenter, parallel-group, randomized, open-label, controlled trial. Patients with a diagnosis of acute heart failure (AHF) in the emergency department (ED) or after emergency presentation to hospital will be screened and informed of the study. After signed consent, patients will be randomized into the control group (usual AHF treatment) or intervention group (usual AHF treatment + prednisone). Prednisone will be given for 7 days. Patients will be assessed at days 2, 4 or at discharge if earlier, and at day 7 at hospital visit. If the patient has been discharged before day 7, a follow-up visit will be scheduled at day 7 for endpoints assessment followed by a scheduled hospital visit at day 31 and a telephone follow-up at day 91. Study drug will be dispensed for the patient to take home until day 7.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 to 85 years of age
  2. 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.
  3. All measures from presentation to randomization of systolic blood pressure ≥ 100 mmHg,and of heart rate ≥ 60 bpm.
  4. Written informed consent to participate in the study.
  5. Biomarker levels indicative of congestion and inflammation: At Screening, NT-proBNP > 1,500 pg/mL and CRP > 20 mg/L
  6. Patient agrees for follow-up visits at the hospital at day 7 in case of earlierdischarge and Day 31.

Exclusion

Exclusion Criteria:

  1. Anticipated life expectancy less than 6 months
  2. Mechanical ventilation (not including CPAP/BIPAP) prior to Screening.
  3. Significant pulmonary disease contributing substantially to the patients' dyspnea suchas FEV1< 1 liter or need for chronic systemic or non-systemic steroid therapy, or anykind of primary right heart failure such as primary pulmonary hypertension orrecurrent pulmonary embolism.
  4. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiacresynchronization therapy (CRT) device implantation within 3 months, or percutaneoustransluminal coronary intervention (PTCI), within 1 month prior to inclusion.
  5. Index Event (admission for AHF) triggered primarily by a correctable etiology such assignificant 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 after admission.Troponin elevations without other evidence of an acute coronary syndrome are not anexclusion.
  6. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophicobstructive cardiomyopathy.
  7. History of heart transplant or on a transplant list, or using or planned to beimplanted with a ventricular assist device.
  8. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior toscreening that is untreated.
  9. Presence at screening of any hemodynamically significant valvular stenosis orregurgitation, except mitral or tricuspid regurgitation secondary to left ventriculardilatation, or the presence of any hemodynamically significant obstructive lesion ofthe left ventricular outflow tract.
  10. Primary liver disease considered to be life threatening
  11. Renal disease or eGFR < 30 or > 80 mL/min/1.73m2 (as estimated by the simplified MDRDformula) at inclusion or history of dialysis.
  12. Systemic steroid therapy, within 30 days from inclusion.
  13. Inability to consent, or patient under guardianship measure
  14. Participation in another intervention trial in the past 30 days
  15. Anticipated non-adherence to study protocol or follow-up.
  16. Pregnant or nursing (lactating) women.
  17. Known hypersensitivity to steroids or constituents of prednisone tablets (excipients)
  18. Psychotic states not yet controlled by treatment
  19. Concomitant administration of live vaccines and up to 3 months after end ofcorticotherapy administration.
  20. Patient under legal protection measure (tutorship or curatorship) and patient deprivedof freedom
  21. Persons subject to psychiatric care without their consent

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Prednisone
Phase:
Study Start date:
August 11, 2023
Estimated Completion Date:
October 31, 2024

Study Description

CORTAHF is a parallel-group, comparative, open-label, randomised (1:1), controlled trial. Patients with a diagnosis of AHF in the ED or after emergency presentation to hospital will be screened and informed of the study. After signed consent, patients will be randomized into the control group (usual AHF treatment) or intervention group (usual AHF treatment + prednisone).

Prednisone will be given for 7 days. Patients will be assessed at days 2, 4 or at discharge if earlier, and at day 7 at hospital visit. If the patient has been discharged before day 7, a follow-up visit will be scheduled at day 7 for endpoints assessment followed by a scheduled hospital visit at day 31 and a telephone follow-up at day 91. Study drug will be dispensed for the patient to take home until day 7.

Connect with a study center

  • "Armenia" Republican Medical Center

    Yerevan,
    Armenia

    Active - Recruiting

  • "Mikaelyan" Surgery Institute

    Yerevan,
    Armenia

    Active - Recruiting

  • Erebouni Medical Center

    Yerevan,
    Armenia

    Active - Recruiting

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