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. 2019 Feb 10;13:1753944719826826. doi: 10.1177/1753944719826826

Table 1.

Trials on implantable hemodynamic monitoring in heart failure patients.

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.