PMID- 27809882
OWN - NLM
STAT- MEDLINE
DCOM- 20180105
LR  - 20181202
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 17
IP  - 1
DP  - 2016 Nov 3
TI  - 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.
PG  - 530
LID - 530
AB  - BACKGROUND: 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 beta-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. METHOD/DESIGN: 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. DISCUSSION: 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 beta-Blocker in the 
      management of patients after diagnosis of HF with preserved EF. The results will 
      be available by 2017. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: 
      NCT02619526 , registered on 25 November 2015.
FAU - Park, Kyungil
AU  - Park K
AD  - 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.
FAU - Park, Tae-Ho
AU  - Park TH
AD  - 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.
LA  - eng
SI  - ClinicalTrials.gov/NCT02619526
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20161103
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Adrenergic alpha-1 Receptor Antagonists)
RN  - 0 (Carbazoles)
RN  - 0 (Cardiotonic Agents)
RN  - 0 (Propanolamines)
RN  - 030Y90569U (Nebivolol)
RN  - 0K47UL67F2 (Carvedilol)
SB  - IM
MH  - Adrenergic alpha-1 Receptor Antagonists/adverse effects/*therapeutic use
MH  - Age Factors
MH  - Aged
MH  - Carbazoles/adverse effects/*therapeutic use
MH  - Cardiotonic Agents/adverse effects/*therapeutic use
MH  - Carvedilol
MH  - Clinical Protocols
MH  - Echocardiography, Doppler
MH  - Female
MH  - Heart Failure/diagnostic imaging/*drug therapy/physiopathology
MH  - Humans
MH  - Male
MH  - Nebivolol/adverse effects/*therapeutic use
MH  - Propanolamines/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Recovery of Function
MH  - Republic of Korea
MH  - Research Design
MH  - Stroke Volume/*drug effects
MH  - Systole
MH  - Time Factors
MH  - Treatment Outcome
MH  - Ventricular Dysfunction, Left/diagnostic imaging/*drug therapy/physiopathology
MH  - Ventricular Function, Left/*drug effects
PMC - PMC5093969
OTO - NOTNLM
OT  - Carvedilol
OT  - Heart failure
OT  - Nebivolol
EDAT- 2016/11/05 06:00
MHDA- 2018/01/06 06:00
PMCR- 2016/11/03
CRDT- 2016/11/05 06:00
PHST- 2015/12/24 00:00 [received]
PHST- 2016/10/13 00:00 [accepted]
PHST- 2016/11/05 06:00 [pubmed]
PHST- 2018/01/06 06:00 [medline]
PHST- 2016/11/05 06:00 [entrez]
PHST- 2016/11/03 00:00 [pmc-release]
AID - 10.1186/s13063-016-1656-y [pii]
AID - 1656 [pii]
AID - 10.1186/s13063-016-1656-y [doi]
PST - epublish
SO  - Trials. 2016 Nov 3;17(1):530. doi: 10.1186/s13063-016-1656-y.