Clinical strategies aiming at achieving an optimal hemodynamic profile have been advocated
for the management of congestive heart failure. Non-invasive estimates, based on
echocardiographic evaluations, might identify outpatients that could benefit from additional
pharmacological therapy. Based on this assumption we conducted a single-center, prospective,
randomized, open-label, blinded endpoint evaluation clinical trial comparing an
echocardiography-guided strategy aimed at achieving a near-normal hemodynamic profile and the
conventional clinically-oriented strategy for congestive heart failure management.
Echocardiography-guided strategy. Patients allocated to the echocardiography-guided strategy
underwent sequential cardiac ultrasound examinations to evaluate hemodynamic-derived
parameters. M-mode and two-dimensional color Doppler echocardiography was performed by an
experienced cardiologist using commercially available ultrasound equipments (ATL HDI 5000,
Bothel, WA, USA). Echocardiographic parameters were evaluated according to standard
recommendations of the American Society of Echocardiography. For each measurement, 3-5
consecutive cardiac cycles were measured and averaged. Hemodynamic parameters were determined
according to previously validated protocols. In brief, pulmonary artery systolic pressure was
estimated as the sum of the estimated right atrial pressure and the pressure gradient between
the right ventricle and right atria. Right atrial pressure was estimated by measuring the
inferior vena cava diameter and its degree of collapsibility during inspiration. Cardiac
output was determined by multiplying heart rate by left ventricular systolic volume. Left
ventricular systolic volume was estimated by multiplying the time-velocity integral of the
left ventricular outflow by the estimated left ventricular outflow area. Systemic vascular
resistance was calculated using standard hemodynamic formulas, incorporating cardiac output
and mean arterial pressure estimations. Systemic vascular resistance and cardiac output were
indexed by body surface area. Each patient assigned to the echocardiography-guided strategy
underwent three consecutive echocardiograms separated by four-week periods and a final
echocardiogram at 6 months. Following each test, all patients were reevaluated by physicians
from the heart failure team. Pharmacological therapy was then guided according to a
pre-defined protocol based on hemodynamic estimates. Firstly, whenever elevated right-sided
filling pressures were detected loop diuretic therapy was incremented irrespective of the
presence of clinical signs and symptoms of pulmonary and/or systemic congestion. Afterwards,
whenever raised systemic vascular resistance was identified, additional vasodilator therapy
was incorporated or optimized, as long as systolic arterial pressure was equal or greater
than 90 mmHg.
Clinically-guided strategy. Therapeutic decisions for patients assigned to the conventional
treatment were based on recommendations from international clinical practice guidelines.
Angiotensin converting enzyme inhibitors and beta-blockers use and optimization were
encouraged. Standard non-pharmacological counseling was also provided by CHF trained nurses
during the first month of follow-up. Diuretic therapy was exclusively based on the presence
and intensity of clinical findings suggestive of pulmonary and/or systemic congestion.
Clinically oriented patients also underwent a baseline and a final echocardiogram, but the
decision-making team was unaware of this data throughout the protocol.