Heart FailureRV-STRAINNCT03969394
The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
A study testing Medical imaging in people with Heart Failure, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The objectives are 1. to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medical imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2017to 30 Sep 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adult Patients with heart failure
Who cannot join
- Renal failure
- Contraindications to Cardiac MRI
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Bernhard Gerber, MD, PhD
Bernhard Gerber, MD, PhD
About this study
The objectives are
- to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis.
- to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.
- Conditions
- Heart Failure
- Being tested
- Medical imaging
- Keywords
- strain, MRI, echocardiography
- Medical subject headings
- Heart Failure, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical imagingDiagnostic test
Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients | Experimental | Patients with Heart Failure Receives: Diagnostic Test: Medical imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 years
Secondary outcomes (1)
Heart Failure
Hospitalization due to heart failure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 Jun 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
- Investigators
- Bernhard Gerber, MD,PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969394
- Sponsor's protocol ID
- 2017/02MAR/117
- Acronym
- RV-STRAIN
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Houard L, Amzulescu MS, Colin G, Langet H, Militaru S, Rousseau MF, Ahn SA, Vanoverschelde JJ, Pouleur AC, Gerber BL. Prognostic Value of Pulmonary Transit Time by Cardiac Magnetic Resonance on Mortality and Heart Failure Hospitalization in Patients With Advanced Heart Failure and Reduced Ejection Fraction. Circ Cardiovasc Imaging. 2021 Jan;14(1):e011680. doi: 10.1161/CIRCIMAGING.120.011680. Epub 2021 Jan 13.
PubMed 33438438
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03969394
- Acronym / sponsor ID
- RV-STRAIN / 2017/02MAR/117
- Conditions
- Heart Failure
- Keywords
- strain, MRI, echocardiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 31 May 2019 (actual)
- 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.
The objectives are
- to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis.
- to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients | Experimental | Diagnostic Test: Medical imagingPatients with Heart Failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients with heart failure
Key exclusion criteria (2 listed)
- Renal failure
- Contraindications to Cardiac MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical imagingMedical Imaging consisting of 1 MRI and 1 echocardiography at baseline | Diagnostic test | Heart Failure Patients |
Primary outcome
overall survival
Time frame: 3 years
1 secondary outcome
Heart Failure
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Derived from this study: PubMed 33438438Houard L, Amzulescu MS, Colin G, Langet H, Militaru S, Rousseau MF, Ahn SA, Vanoverschelde JJ, Pouleur AC, Gerber BL. Prognostic Value of Pulmonary Transit Time by Cardiac Magnetic Resonance on Mortality and Heart Failure Hospitalization in Patients With Advanced Heart Failure and Reduced Ejection Fraction. Circ Cardiovasc Imaging. 2021 Jan;14(1):e011680. doi: 10.1161/CIRCIMAGING.120.011680. Epub 2021 Jan 13.
- Individual participant dataSharing planned: No
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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.
Bernhard Gerber, MD,PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical imaging in people with Heart Failure, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 May 2019. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernhard Gerber, MD,PhD (+3227642803, Bernhard.Gerber@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 years). 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 NCT03969394, 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 31 May 2019.