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Intrathoracic Bloodvolume Measurement by Contrast Enhanced Ultrasound: Validation of the Technique and Evaluation as a Measurement of Response to Cardiac Resynchronization Therapy: a Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735838
First Posted: November 28, 2012
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ingeborg Herold, Catharina Ziekenhuis Eindhoven
  Purpose

Summary Rationale: Cardiac resynchronisation therapy (CRT) with biventricular pacemakers and implantable cardiac defibrillators (ICD) has proven to be a valuable therapy in selected patients with systolic heart failure, ameliorating both morbidity and mortality. However, with current selection criteria and implant technique, about 20 to 30 % of patients remain non-responders. Non-responders might be due to failing selection criteria or methodology in casu echocardiography. Moreover, the definition of response to CRT is unequivocal and there is a need for a simple and reproducible measure of response with low inter- and intra-observer variability.

Primary objectives: This study evaluates the correlation between intrathoracic blood volume (ITBV) measured by contrast enhanced ultrasound (CEUS) and magnetic resonance imaging (MRI), as well as the feasibility to use intrathoracic blood volume as a predictor for response to CRT.

Study design: a prospective nonrandomized pilot study Study population: patients with heart failure New York Heart Association (NYHA) class III or IV, a left ventricular ejection fraction equal to or less than 35% and a QRS-duration equal to or more than 0.12 seconds who are referred to our centre for implantation of a CRT-P or CRT-D device.

Intervention: No specific intervention will be performed. Main study parameters: correlation between intrathoracic bloodvolume measured by CEUS and MRI, correlation between LVEF measured by CEUS and by standard 2D ultrasound (biplane methods of discs), change in intrathoracic blood volume as a response to CRT.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: at baseline a clinical examination, laboratory analysis, cardiopulmonary exercise testing, echocardiography and cardiac magnetic resonance imaging will be performed. All of these examinations will be repeated at 3-months follow-up except for the cardiac magnetic resonance imaging. All examinations, except for the MRI, are part of the standard workup in our hospital for patients undergoing implantation of a CRT device. Data needed for the purpose of this study, will be acquired by offline image analysis with dedicated software.


Condition
Intrathoracic Blood Volume in Heart Failure Patients

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Intrathoracic Bloodvolume Measurement by Contrast Enhanced Ultrasound: Validation of the Technique and Evaluation as a Measurement of Response to Cardiac Resynchronization Therapy: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Ingeborg Herold, Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • a. change in ITBV measured by CEUS before and after CRT [ Time Frame: two years anticipated ]
  • b. correlation of ITBV measured by CEUS and MRI before CRT [ Time Frame: two years anticipated ]

Secondary Outcome Measures:
  • a. correlation between LVEF estimated with CEUS and standard contrast 2D ultrasound [ Time Frame: two years anticipated ]
  • b. correlation between LVEF estimated with CEUS and MRI [ Time Frame: two years anticipated ]

Enrollment: 20
Study Start Date: June 2012
Study Completion Date: July 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients referred to our centre for implantation of a CRT-P or CRT-D device are eligible. In the pilot phase 20 patients will be included. Data will be collected at baseline and 3 months post-implantation.
Criteria

Inclusion Criteria:

  1. Age ≥18y
  2. LVEF ≤35%
  3. QRS-duration ≥0.12 seconds
  4. NYHA functional class III or IV despite optimal medical therapy defined as use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor blocker and beta-blockers unless they are not tolerated or contra-indicated
  5. sinus rhythm or atrial fibrillation

Exclusion Criteria:

  1. episode of acute heart failure ≤3 months
  2. change in dosage of beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin-II receptor blockers ≤3 months
  3. unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery ≤3 months
  4. chronic atrial arrhythmias other than atrial fibrillation
  5. any mechanical or biological valve prosthesis
  6. atrial septal defect
  7. right-to-left shunt
  8. severe pulmonary hypertension (systolic pulmonary artery pressure >90 mmHg)
  9. uncontrolled arterial hypertension
  10. known allergy to sulphur hexafluoride
  11. end-stage renal or hepatic disease
  12. inability to provide written informed consent
  13. pregnancy or childbearing potential without use of birth-control measurements
  14. general contra-indications to magnetic resonance imaging
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735838


Locations
Netherlands
Catharina Hospital Eindhoven
Eindhoven, Netherlands, 4194 TR
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: I.H.F. Herold, MD Catharina Ziekenhuis Eindhoven
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ingeborg Herold, MD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01735838     History of Changes
Other Study ID Numbers: NL39385.060.12
First Submitted: November 26, 2012
First Posted: November 28, 2012
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases