The effect of beta-adrenergic receptor blockade on sympathetic activity and coagulation in patients with heart failure (BACH-F study)

Conditions: Congestive heart failure
systolic heart failure
10019280

Registration Number: NL-OMON31270

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Patients
1. Between 18 and 80 years of age, competent and willing of giving informed consent;
2. With stable symptoms of chronic heart failure (NYHA II-III);
3. With left ventricular ejection fraction *40%, measured within the previous 6 months; if the ejection fraction is not determined, a left-ventricular end diastolic diameter of greater then 6.0 cm and a fractional shortening of less than 20% as measured by echocardiography;
4. With sinusrhythm; (necessary to perform spectral analysis);
5. On stable medical therapy with ACE-inhibitors for at least three months, unless contraindicated; otherwise angiotensin receptor blockers (ARBs);
6. Already on beta-blocker therapy with maximal tolerated doses;;And healthy subjects between 18 and 80 years of age serve as controls to compare sympathetic and hypercoagulable activity with heart failure patients.

Exclusion Criteria

Excluded are patients
1. With a history of adverse reaction on beta-blockers;
2. With a contraindication to *-blocker therapy (Sick-sinussyndrome, second and third AV-block), severe hypotension (systolic blood pressure < 100 mm Hg), cardiogenous shock, clinical relevant sinusbradycardia. Asthma, COPD. Liverfunctiondisorder (defined as elevation of aspartamine transaminase, alanine transaminase or bilirubin levels more than three times upper limit of normal range), renal disease (calculated creatinine clearance <50ml/min; using Cockcorft's formula).Insulin dependent diabetes mellitus.);
3. With an acute coronary syndrome or myocardial revascularisation within the preceding 3 months;
4. Who are using anticoagulant therapy. Aspirin is allowed;
5. With severe aortic or mitral valve disease or aortic regurgitation;
6. With right ventricle failure;
7. Requirement for intravenous inotropic therapy, current treatment with calcium channel blockers (of the diltiazem or verapamil class), amiodaron (>200mg per day) or class-I antiarrhythmic drugs, or administration of any investigational drug in the preceding 30 days.
8. Uncontrolled hypertension (blood pressure systolic >170 mmHg or diastolic >105mmHg),
9. Symptomatic and sustained ventricular arrhythmias within the preceding two months not adequately treated with antiarrhythmic drugs or without implantation of an automatic defibrillator;
10. With implanted pacemaker (necessary for spectral analysis); ICD is allowed
11. Pregnancy and women with childbearing potential on inadequate contraception
12. Known drug or alcohol misuse
13. Poor compliance with treatment
14. Any other serious systemic disease that might complicate management and reduce life expectancy.
15. With a known allergy for Iodine;Excluded are healthy controls
1. Taking any medication that will affect our outcome measurements for at least 2 weeks before entering the study
2. With a history of adverse reaction on beta-blockers
3. With a contraindication to beta-blocker therapy as described for patients with heart failure
4. With pregnancy and women with childbearing potential on inadequate contraception
5. Known drug or alcohol misuse
6. Known with poor compliance with treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will assess two primary endpoints at rest and during exercise: 1.<br /><br>hypercoagulable activity by platelet function and thrombin generation; 2.<br /><br>sympathetic activity by plasma (nor)adrenalin concentration, spectral analysis<br /><br>of blood pressure and heart rate variability. And in patients with heart<br /><br>failure by 123I-MIBG scinitigraphy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Changes in coagulation factors;<br /><br>2. Changes in fibrinolysis;<br /><br>3. Cardiac output as calculated by Finapres (BMEYE ABM 100 HD);<br /><br>4. Central blood pressure as measured by Sphygmocor;<br /><br>5. Patient*s satisfaction with the two different treatments by using a<br /><br>questionnaire.</p><br>

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