Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280254
Status:
TERMINATED
Last Update Posted:
2006-01-20
First Post:
2006-01-19
Brief Title:
A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Federal University of Rio Grande do Sul
Study Overview
Official Title:
A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
Status:
TERMINATED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to compare two strategies in the treatment of outpatients with heart failure We hypothesized that an individualized treatment strategy based on the availability of hemodynamic data from non-invasive testing would be feasible and significantly reduce morbidity compared to the conventional clinically oriented treatment of heart failure outpatients
Detailed Description:
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 andor 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 andor 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
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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None