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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Catharina Ziekenhuis Eindhoven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01735838
First received: November 26, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  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 Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • a. change in ITBV measured by CEUS before and after CRT [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]
  • b. correlation of ITBV measured by CEUS and MRI before CRT [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • a. correlation between LVEF estimated with CEUS and standard contrast 2D ultrasound [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]
  • b. correlation between LVEF estimated with CEUS and MRI [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735838

Contacts
Contact: I.H.F. Herold, MD 402399111 ext +31 Ingeborg.Herold@cze.nl

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

No publications provided

Responsible Party: Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01735838     History of Changes
Other Study ID Numbers: NL39385.060.12
Study First Received: November 26, 2012
Last Updated: November 26, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014