Phase
Condition
Congestive Heart Failure
Hyponatremia
Heart Failure
Treatment
N/AClinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of informed consent prior to any study specific procedure
Male or female, aged ≥ 19 years
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Associationclassification) class II-IV and preserved EF (Ejection Fraction)(LVEF (LeftVentricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of theprohormone brain natriuretic peptide) > 200 pg/ml for patients without AF, OR > 600pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
Structural heart disease within 6 months prior to Visit 1 using echocardiagraphy
Exclusion
Exclusion Criteria:
Myocardial infarction, coronary artery bypass graft surgery or other majorcardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 daysprior to Visit 1
Contraindication to beta blocker
Heart transplant recipient or listed for heart transplant
Hospitalization plan for PCI, coronary artery bypass graft surgery, other cardiacinvasive interventions (e.g. catheter ablation, pacemaker, CRT, ICD implantation)
Acute decompensated HF (Heart Failure)
Symptomatic hypotension or systolic blood pressure < 100 mmHg)
Patients with CrCl < 30 ml/min using creatinine-based CKD-EPI equations
Elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis
Symptomatic bradycardia or heart rate < 60/min
Allergy, adverse drug reaction, hypersensitivity to carvedilol
Life expectancy < 6 months (e.g. metastatic malignancy)
Pregnancy, or women of childbearing age
Study Design
Connect with a study center
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
Korea, Republic ofSite Not Available
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