| Study name |
Carvedilol SR study for biomarkers from blood and urine and safety of in patients with heart failure with preserved ejection fraction |
| Methods |
Study design: parallel RCT
Anticipated completion date: January 2021 |
| Participants |
Estimated enrolment: 300
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 Association classification) class II‐IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT‐proBNP (N‐terminal of the prohormone brain natriuretic peptide) > 200 pg/ml for patients without AF, OR > 600 pg/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 criteria:
Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior 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 cardiac invasive 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
|
| Interventions |
Carvedilol SR versus placebo
24 weeks |
| Outcomes |
NT‐proBNP; changes of maximum surrogate markers values(hsTn, hsCRP, sST2, Galectine‐3, IGFBP7, Neprilysin, D‐dimer, MMP‐2, Cystatin C, NAG, NGAL, KIM‐1, BUN, Creatinine, Chloride, Na, K, PICP and spondin‐1); degree of dyspnea using VAS questionnaire; change of body weight; frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree; frequency of hypo/hyperkalemia and worsening kidney function; all‐cause hospitalization & mortality |
| Starting date |
May 2019 |
| Contact information |
Seok‐Min Kang: smkang@yuhs.ac
|
| Notes |
|
