1. Heart failure
Conditions
Interventions
Carvedilol versus Metoprolol retard in crossover design.
Sponsors
P.W. Kamphuisen, internist, Vasculair Geneeskundige.
Eligibility
Inclusion criteria
Inclusion criteria: 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 ¡Ü40%, 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; Digitalis or other vasodilatators can be used at the discretion of the treating physicians; Healthy subjects between 18 and 80 years of age serve as controls to compare sympathetic and hypercoagulable activity with heart failure patients.
Exclusion criteria
Exclusion criteria: 1. With a history of adverse reaction on beta-blockers; 2. With a contraindication to â-blocker therapy (Sick-sinussyndrome, second and third AV-block), severe hypotension (systolic blood pressure 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. Known with an 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sympathetic activity as measured by spectral analysis of blood pressure and heart rate vaiability and by MIBG-scintigraphy. Hemostasis (platelet activity and thrombin generation and other coagulaiton factors). Both measured at the end of each treatment period. In healthy volunteers also as a baseline measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Central blood pressure / augmentation index. | — |
Contacts
Public ContactO.R. Peuter de
Academic Medical Center - University of Amsterdam Department of Vascular Medicine (Room F4-139) PO BOX 22660
Outcome results
None listed