Trial included one-third women, one-fourth blacks
The Beta-Blocker Evaluation of Survival Trial (BEST) tested the hypothesis that the addition of a beta adrenergic blocking agent to standard therapy — diuretics, digitalis, and an ACE inhibitor — would reduce mortality in men and women with moderate to severe CHF.
Gina Edness, RN, BSN, cardiomyopathy research nurse coordinator at Johns Hopkins Medical School in Baltimore had the responsibility of screening and recruiting patients for BEST. Once patients were in the study, she arranged close follow-up. "When there was uptitration of meds, they came in every two weeks in addition to frequent telephone calls. We had to ensure that they knew to call if there were any adverse events or side effects to the drug," she explains.
After initial uptitration, they were seen every three months and given MUGA scans — radionuclide ventriculograms — as well as chest X-rays and EKGs to look for reverse remodeling. "In cardiomyopathy patients, the heart gets smaller as ejection fraction improves." After that, there’s follow-up every six months, then at 12 months. At 12 months, the team repeated the MUGAs, chest X-rays, and EKGs. "Of course at every visit, we did a physician exam and discussed the side effects and any hospitalizations the patient may have had," she explains.
Edness says BEST had a veteran population, and that had a lot to do with the larger percentage of black patients. "Also, we intentionally wanted to look at more blacks and more women. Typically in research white males are included in studies more than blacks and women."
- Inclusion criteria:
• Age > 18 years
• Left ventricular ejection fraction < 0.35
• NYHA Functional Class III or IV
• Female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception.
• Current treatment (for at least 30 days) with an ACE inhibitor if tolerated and digitalis unless contraindicated
• Competent to give informed consent
- Exclusion criteria:
• CHF due to uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, or malfunctioning artificial heart valve
• Heart transplant candidates
• Acute myocardial infarction within six months
• CABG, PTCA, or other cardiac surgery within 60 days; PTCA or cardiac surgery contemplated
• Severe or unstable angina (use of > six sublingual NTG weekly)
• Excluded medications: beta-blockers, calcium channel blockers, methylxanthines, tricyclic and tetracyclic antidepressants, MAO inhibitors, beta agonists, sympathomimetics, inotropes other than digitalis, certain antiarrhythmics with negative inotropic properties and amiodarone, or any other investigational agent
• Contraindication to beta adrenergic blockade
• Life expectancy < three years due to other life-threatening disease
• Active liver (total bilirubin > 3.0 mg %) or renal (creatinine > 3.0 mg %) disease, or any other disease that may affect the safety or efficacy of the study drug or life expectancy of the patient
• Uncontrolled diabetes mellitus with a history of hypoglycemic episodes
• Unstable decompensated heart failure
• An automatic, implantable cardiologic defibrillator that fired within three months
• Asymptomatic resting but awake heart rate < 50 bpm or symptomatic bradycardia with a heart rate < 60 bpm
• High degree AV block
• Active abuse of ethanol — > 00 gm ethanol/day
• Demonstrated noncompliance with previous medications