Table 1.
Name of trial | Type of trial | NYHA functional class | Clinical endpoints | Specific inclusion criteria | Number of patients enrolled | Duration of clinical trial | |
---|---|---|---|---|---|---|---|
1. | CHAMPION trial30 |
Double-blind, randomized control study | III | Reduction in hospitalization | Diagnosis of HF for 3 months with preserved or reduced EF and BMI < 35 kg/m2 | 550 | Until last enrolled patient reached 6 months |
2 | PAPIRUS trial39 |
Prospective, multicenter phase I study | III, IV | Home monitoring of PAP was feasible, safe and accepted by patients in every day ambulatory conditions | Age > 18 years and followed regularly in HF clinic for 6 months | 31 | 6 months |
3 | REDUCE-HF trial41 | Prospective, multicenter, single-blind, randomized, parallel-controlled study | II, III | Use of a single chamber AICD with a hemodynamic monitoring system Primary endpoint was met but the rates of hospitalization and urgent care visits did not differ between groups |
Age > 18 years and eGFR > 30 ml/min/m2 | 850 | 12 months |
4 | COMPASS-HF trial40 | Prospective, multicenter, single-blind randomized, parallel-controlled study | III, IV | Chronicle group had an insignificant 21% lower rate of all HF-related events compared with the control group | Age > 18 years and received optimal medical HF therapy for at least 3 months prior to enrollment | 274 | 6 months |
5. | GUIDE-HF trial (ongoing)46 |
Prospective, multicenter, single-blind randomized, parallel-controlled study | II, III, IV | Recurrent heart failure hospitalization; death from any cause | Age > 18 years; Diagnosis and treatment for HF (regardless of LVEF) for >90 days | 3600 | 5 years |
AICD, implantable cardioverter defibrillator; BMI, body mass index; EF, ejection fraction; eGFR, estimated glomerular filtration rate; HF, heart failure; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PAP, pulmonary artery pressure.