Advertisement

Topics

A Prospective, Open-labeled Trial in Patients With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea

2014-08-27 03:15:42 | BioPortfolio

Summary

This is a prospective, open-labeled, multicentric trial to evaluate the effect of bisoprolol (between low-dose and high dose) on surrogate markers of heart failure in Korea.

Description

Subjects with systolic congestive heart failure (CHF) will be enrolled in this study after proper evaluation of N-terminal pro b-type natriuretic peptide (NT-proBNP), global assessment of CHF, 6-minute walking test and improvement score of New York Heart Association (NYHA) and echocardiogram [left ventricular chamber size and ejection fraction (EF)]. Each subject will be orally administered bisoprolol for 6 months starting at 1.25 mg at the Week 0 and titrated upto 10 mg during the 6 month period if the persistent standing systolic blood pressure (SBP) is > 90 mm Hg and there is no symptom of hypotension at the current dose medication (syncope, LOC ?full form, dizziness at standing up.

OBJECTIVES

Primary objective:

- To evaluate the effect of bisoprolol (between low-dose and high-dose) on surrogate markers of heart failure in Korea

Secondary objectives:

- To evaluate bisoprolol for the effects on clinical improvement of heart failure in Korea:

1. Global assessment of CHF

2. NYHA, physician assessment, 6 minutes walking test

3. Echocardiogram

- To evaluate bisoprolol for the effects on major clinical event of heart failure in Korea

- To evaluate the safety and tolerability of bisoprolol

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Heart Failure, Congestive

Intervention

Bisoprolol

Location

Seoul National University Hospital
Seoul
Korea, Republic of

Status

Recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

Clinical Trials [2092 Associated Clinical Trials listed on BioPortfolio]

Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of lif...

Treating Congestive Heart Failure Using a Device to Remove Cholesterol

A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure. Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will de...

Congestive Heart Failure: Causes of Sudden Worsening

The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.

A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure

The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of Natrecor® (a recombinant form of the natural human ...

Study of DITPA in Patients With Congestive Heart Failure

This study will assess the safety and efficacy of DITPA relative to placebo in patients with New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) who have low s...

PubMed Articles [6885 Associated PubMed Articles listed on BioPortfolio]

Associations between ambient air pollution and daily mortality in a cohort of congestive heart failure: Case-crossover and nested case-control analyses using a distributed lag nonlinear model.

Persons with congestive heart failure may be at higher risk of the acute effects related to daily fluctuations in ambient air pollution. To meet some of the limitations of previous studies using group...

COSYREL - an efficient fixed combination for treatment of hypertension, stable ISHD and heart failure.

Fixed combinations of two or three drugs are being frequently used in cardiovascular diseases. This approach markedly increases adherence of the patients to prolonged therapy and thus leads to better ...

Myocardial oedema and congestive heart failure: one piece of the puzzle? Reply.

Good response to tolvaptan shortens hospitalization in patients with congestive heart failure.

Tolvaptan has been gradually spread to use as a potent diuretic for congestive heart failure in the limited country. However, the response to this aquaretic drug still is unpredictable. A total of 92 ...

Effects and safety of oral tolvaptan in patients with congestive heart failure: A systematic review and network meta-analysis.

Several studies reported treatment benefits of tolvaptan in patients with congestive heart failure (CHF). However, the optimal dosage remains unclear. We aimed to compare different dosage of tolvaptan...

Medical and Biotech [MESH] Definitions

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)

Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).

A semisynthetic digitalis glycoside with the general properties of DIGOXIN but more rapid onset of action. Its cardiotonic action is prolonged by its demethylation to DIGOXIN in the liver. It has been used in the treatment of congestive heart failure (HEART FAILURE).

A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Disease of CARDIAC MUSCLE resulting from chronic excessive alcohol consumption. Myocardial damage can be caused by: (1) a toxic effect of alcohol; (2) malnutrition in alcoholics such as THIAMINE DEFICIENCY; or (3) toxic effect of additives in alcoholic beverages such as COBALT. This disease is usually manifested by DYSPNEA and palpitations with CARDIOMEGALY and congestive heart failure (HEART FAILURE).

More From BioPortfolio on "A Prospective, Open-labeled Trial in Patients With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...


Searches Linking to this Trial