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DIG TRIAL |
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| Problem | CCF (EF < 45%) |
| Format | Double-blinded multi-center RCT |
| Treatment | Digoxin |
| Control | Placebo |
| Population | 6800 |
| Inclusion criteria | Patients were eligible for the main trial if they had heart failure and a left ventricular ejection fraction of 0.45 or less (6800 patients) and were in normal sinus rhythm. Patients with heart failure and a left ventricular ejection fraction of more than 0.45 (988 patients) were enrolled in an ancillary trial conducted parallel to the main study. The diagnosis of heart failure was based on current or past clinical symptoms (limitation of activity, fatigue, and dyspnea or orthopnea), signs (edema, elevated jugular venous pressure, rales, or S3 gallop), or radiologic evidence of pulmonary congestion. Patients were eligible for the study whether or not they were already being treated with digoxin. Doctors were strongly encouraged to co-prescribe ACEi in both digoxin & control groups. |
| Exclusion criteria | Age < 21 years Baseline left ventricular EF not available Myocardial infarction, cardiac surgery, or percutaneous transluminal coronary angio-plasty (PTCA) within 4 weeks Unstable or refractory angina < 1 month 2nd or 3rd AV block without a pacemaker Atrial fibrillation (with or without pacemaker) or atrial flutter Cor pulmonale Constrictive pericarditis (such patients are eligible after surgery) Acute myocarditis Hypertrophic cardiomyopathy Amyloid cardiomyopathy Complex congenital heart disease Pre-excitation syndromes Current treatment with intravenous inotropic agents Potassium below 3.2 mmoI/L or above 5.5 mmol/L Need for cardiac surgery (e.g., severe valvular disease, planned coronary artery bypass graft surgery) or PTCA in the near future. (Such patients are eligible after surgery or PTCA.) Patients on heart transplant list are not eligible Sick sinus syndrome without pacemaker Recognizable noncardiac causes of CHF Significant renal insufficiency (creatinine > 3.0 mg/dL) or severe liver disease. Any noncardiac disease that shortens life expectance to less than 3 years (e.g. most cancers) Patient is unlikely to comply with the protocol requirements for follow-up and drug adherence (e.g. chronic alcoholism, no fixed address) |
| Follow-up | Mean 37 months |
| Primary endpoint | Mortality from any cause |
| Secondary endpoint(s) | Hospitalization for heart failure |
| Details | Patients with heart failure and a left ventricular ejection fraction of more than 0.45 (988 patients) were enrolled in an ancillary trial conducted parallel to the main study. |
| Brief summary: | Digoxin reduced CCF hospitalisation but not mortality |
| PAPER: The effect of digoxin on mortality and morbidity in patients with heart failure. The Digitalis Investigation Group. | |
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| Date | 20 Feb 1997 |
| Journal | N Engl J Med. 1997 Feb 20;336(8):525-33. |
| Information | Digoxin (+-ACE/diuretic) vs. placebo (+-ACE/diuretic) -No difference in mortality (RR 0.99; p=0.8) -Reduced hospitalisation for HF (RR 0.72; p<0.001) -6% fewer all-cause hospitalisation (p=0.01) Ancillary trial (EF > 45% - \"diastolic HF\") -No difference in mortality -Similar trend towards reduce hospitalisation |