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

This study has been terminated.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Hospital de Clinicas de Porto Alegre
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00280254
First received: January 19, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Heart Failure
Procedure: Hemodynamically Oriented Echocardiography-based Strategy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Hemodynamically Oriented Echocardiography-Based Strategy in the Treatment of Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

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.

Estimated Enrollment: 102
Study Start Date: November 1999
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280254

Sponsors and Collaborators
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Nadine O Clausell, MD Federal University of Rio Grande do Sul. Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00280254     History of Changes
Other Study ID Numbers: HCPA-ICC01
Study First Received: January 19, 2006
Last Updated: January 19, 2006
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
Heart Failure
Hemodynamics
Echocardiography

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014