Comparative effects of nebivolol and carvedilol on left ventricular diastolic function in older heart failure patients with preserved ejection fraction: study protocol for a randomized controlled trial.
Heart failure (HF) is a common and disabling condition in older people. Randomized clinical trials and meta-analyses have clearly demonstrated that the long-term use of β-Blockers improves the outcome of patients with HF. However, limited data are available on the treatment of older HF patients with preserved ejection fraction (EF). No study has specifically compared the relative effectiveness of carvedilol and nebivolol in treating HF in older patients with preserved EF.



This trial is a prospective, randomized, open-label, single-centre, active controlled study designed to investigate the effects of nebivolol and carvedilol on diastolic function of the left ventricle (LV) in older HF patients with preserved EF. We will test the hypothesis that nebivolol improves LV diastolic function to a greater extent than carvedilol in patients over 70 years of age. The study population includes 62 older patients newly diagnosed with HF. Patients will be included in the study if they have a LVEF ≥40 %, New York Heart Association (NYHA) functional classes I, II or III status, and have been clinically stable without hospital admission for HF in the preceding 3 months. Eligible patients will be randomly assigned, in a 1:1 ratio, to receive a loading and maintenance dose of either nebivolol or carvedilol. Echocardiographic evaluations will be performed at baseline, 6, and 12 months after therapy. Clinical assessment and laboratory tests are to be performed at fixed times.



This trial is a single-center study that aims to evaluate the impact of nebivolol on LV diastolic function. The results of the study will provide information about the optimal choice of a β-Blocker in the management of patients after diagnosis of HF with preserved EF. The results will be available by 2017.



ClinicalTrials.gov Identifier: NCT02619526 , registered on 25 November 2015.
Division of Cardiology, Department of Internal Medicine, Dong-A University College of Medicine, 1 Dongdae-sin-dong 3-ga, Seo-gu, Busan, 602-715, South Korea.
Kyungil
K
Park
Division of Cardiology, Department of Internal Medicine, Dong-A University College of Medicine, 1 Dongdae-sin-dong 3-ga, Seo-gu, Busan, 602-715, South Korea. thpark65@dau.ac.kr.
Tae-Ho
TH
Park
D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D002227:Carbazoles / Q000009:adverse effects / Q000627:therapeutic use*; D002316:Cardiotonic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077261:Carvedilol; D002985:Clinical Protocols; D015150:Echocardiography, Doppler; D005260:Female; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D000068577:Nebivolol / Q000009:adverse effects / Q000627:therapeutic use*; D011412:Propanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D020127:Recovery of Function; D056910:Republic of Korea; D012107:Research Design; D013318:Stroke Volume / Q000187:drug effects*; D013599:Systole; D013997:Time Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D016277:Ventricular Function, Left / Q000187:drug effects*
D058668:Adrenergic alpha-1 Receptor Antagonists; D002227:Carbazoles; D002316:Cardiotonic Agents; D011412:Propanolamines; D000068577:Nebivolol; D000077261:Carvedilol
Carvedilol; Heart failure; Nebivolol