A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure

January 19, 2006 updated by: Federal University of Rio Grande do Sul
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

102

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age greater than 18 years old,
  2. CHF diagnosis for more than 6 months regardless of etiology,
  3. echocardiography-based left ventricular ejection fraction equal or less than 40%, and
  4. prior CHF admission within three months from randomization

Exclusion Criteria:

  1. thoracic deformity or severe chronic lung disease imposing technical limitation to perform high-quality echocardiography,
  2. acute coronary syndrome in the last three months,
  3. congenital heart disease,
  4. moderate to severe stenotic heart valve disease or
  5. end-stage renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Nadine O Clausell, MD, Federal University of Rio Grande do Sul. Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Estimate)

January 20, 2006

Last Update Submitted That Met QC Criteria

January 19, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPA-ICC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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