Intrathoracic Blood Volume in Heart Failure PatientsNCT01735838
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
An observational study of Intrathoracic Blood Volume in Heart Failure Patients, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrathoracic Blood Volume in Heart Failure Patients
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18y
- LVEF ≤35%
- QRS-duration ≥0.12 seconds
- 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
- sinus rhythm or atrial fibrillation
Who cannot join
- episode of acute heart failure ≤3 months
- change in dosage of beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin-II receptor blockers ≤3 months
- unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery ≤3 months
- chronic atrial arrhythmias other than atrial fibrillation
- any mechanical or biological valve prosthesis
- atrial septal defect
Show all 14Show fewer
- right-to-left shunt
- severe pulmonary hypertension (systolic pulmonary artery pressure >90 mmHg)
- uncontrolled arterial hypertension
- known allergy to sulphur hexafluoride
- end-stage renal or hepatic disease
- inability to provide written informed consent
- pregnancy or childbearing potential without use of birth-control measurements
- general contra-indications to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
a. change in ITBV measured by CEUS before and after CRT
Measured: two years anticipated
b. correlation of ITBV measured by CEUS and MRI before CRT
Measured: two years anticipated
Secondary outcomes (2)
a. correlation between LVEF estimated with CEUS and standard contrast 2D ultrasound
Measured: two years anticipated
b. correlation between LVEF estimated with CEUS and MRI
Measured: two years anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrathoracic Blood Volume in Heart Failure PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingeborg Herold, Catharina Ziekenhuis Eindhoven
- Investigators
- I.H.F. Herold, MD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735838
- Sponsor's protocol ID
- NL39385.060.12
- Status last verified
- Jan 2016
- First submitted
- 26 Nov 2012
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Herold IH, Saporito S, Mischi M, van Assen HC, Bouwman RA, de Lepper AG, van den Bosch HC, Korsten HH, Houthuizen P. Pulmonary transit time measurement by contrast-enhanced ultrasound in left ventricular dyssynchrony. Echo Res Pract. 2016 Jun;3(2):35-43. doi: 10.1530/ERP-16-0011. Epub 2016 May 16.
PubMed 27249553
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01735838
- Acronym / sponsor ID
- NL39385.060.12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Age ≥18y
- LVEF ≤35%
- QRS-duration ≥0.12 seconds
- 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
- sinus rhythm or atrial fibrillation
Key exclusion criteria (14 listed)
- episode of acute heart failure ≤3 months
- change in dosage of beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin-II receptor blockers ≤3 months
- unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery ≤3 months
- chronic atrial arrhythmias other than atrial fibrillation
- any mechanical or biological valve prosthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Derived from this study: PubMed 27249553Herold IH, Saporito S, Mischi M, van Assen HC, Bouwman RA, de Lepper AG, van den Bosch HC, Korsten HH, Houthuizen P. Pulmonary transit time measurement by contrast-enhanced ultrasound in left ventricular dyssynchrony. Echo Res Pract. 2016 Jun;3(2):35-43. doi: 10.1530/ERP-16-0011. Epub 2016 May 16.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I.H.F. Herold, MD principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrathoracic Blood Volume in Heart Failure Patients, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a. change in ITBV measured by CEUS before and after CRT (time frame: two years anticipated). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01735838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.