A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hemodynamically Oriented Echocardiography-based Strategy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Hemodynamics, Echocardiography
Eligibility Criteria
Inclusion Criteria: age greater than 18 years old, CHF diagnosis for more than 6 months regardless of etiology, echocardiography-based left ventricular ejection fraction equal or less than 40%, and prior CHF admission within three months from randomization Exclusion Criteria: thoracic deformity or severe chronic lung disease imposing technical limitation to perform high-quality echocardiography, acute coronary syndrome in the last three months, congenital heart disease, moderate to severe stenotic heart valve disease or end-stage renal failure
Sites / Locations
Outcomes
Primary Outcome Measures
The primary efficacy end-point was time to the first event of combined all-cause mortality and all-cause hospitalization or emergency room visit
Secondary Outcome Measures
Secondary end-points were changes in hemodynamic estimates (right atrial pressure, systolic pulmonary artery pressure and systemic vascular resistance), serum electrolytic measurement and renal function.
Full Information
NCT ID
NCT00280254
First Posted
January 19, 2006
Last Updated
January 19, 2006
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00280254
Brief Title
A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
Official Title
A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Terminated
Study Start Date
November 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Hospital de Clinicas de Porto Alegre
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Hemodynamics, Echocardiography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hemodynamically Oriented Echocardiography-based Strategy
Primary Outcome Measure Information:
Title
The primary efficacy end-point was time to the first event of combined all-cause mortality and all-cause hospitalization or emergency room visit
Secondary Outcome Measure Information:
Title
Secondary end-points were changes in hemodynamic estimates (right atrial pressure, systolic pulmonary artery pressure and systemic vascular resistance), serum electrolytic measurement and renal function.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age greater than 18 years old,
CHF diagnosis for more than 6 months regardless of etiology,
echocardiography-based left ventricular ejection fraction equal or less than 40%, and
prior CHF admission within three months from randomization
Exclusion Criteria:
thoracic deformity or severe chronic lung disease imposing technical limitation to perform high-quality echocardiography,
acute coronary syndrome in the last three months,
congenital heart disease,
moderate to severe stenotic heart valve disease or
end-stage renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine O Clausell, MD
Organizational Affiliation
Federal University of Rio Grande do Sul. Medical School
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure
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