Congestive Heart FailureHERACLES-HFpEFNCT04782908
Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients
A study testing Transcatheter tricuspid valve edge-to-edge repair in people with Congestive Heart Failure and Tricuspid Regurgitation, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial summary
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Tricuspid Regurgitation
- What is being tested?
- Transcatheter tricuspid valve edge-to-edge repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2021to 30 Jun 2022
- 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
- Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
- Signs and symptoms of left-sided heart failure.
- Left-ventricular ejection fraction ≥50%
- Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure [PCWP] or left-ventricular end-diastolic pressure ≥15 mmHg)
Who cannot join
- Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
- Moderate aortic stenosis.
- Pregnancy
- Contraindication to perform cardiac magnetic resonance imaging.
- Conditions rendering patient unable to give informed consent to the study protocol.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heart Centre at University Leipzig
Leipzig, Saxony, 04289
Karl-Patrik Kresoja, MD, 0341 865 252596, karl-patrik.kresoja@medizin.uni-leipzig.de
Philipp Lurz, MD, PhD, 0341 865 252529, philipp.lurz@medizin.uni-leipzig.de
About this study
Official title: Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.
- Conditions
- Congestive Heart Failure, Tricuspid Regurgitation
- Being tested
- Transcatheter tricuspid valve edge-to-edge repair
- Keywords
- Heart failure with preserved ejection fraction, tricuspid regurgitation, transcatheter tricuspid valve edge-to-edge repair
- Medical subject headings
- Heart Failure, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter tricuspid valve edge-to-edge repairDevice
Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter tricuspid valve edge-to-edge repair | Experimental | Patients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR. Receives: Device: Transcatheter tricuspid valve edge-to-edge repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Measured: Periprocedural.
Secondary outcomes (4)
Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR)
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Measured: Periprocedural.
Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Measured: Periprocedural.
Change in dPdtmin
Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
Measured: Periprocedural.
Change in the early diastolic filling pattern as assessed by MRI.
All patients will receive MRI before and 1-month after TTVR on a 1.5 tesla scanner.
Measured: Baseline and 1-month follow-up following TTVR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients undergoing transcatheter tricuspid valve edge-to-edge repair will undergo multimodal cardiovascular diagnostics before and after tricuspid valve repair including pressure volume loop analysis and cardiac magnetic resonance imaging
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782908
- Sponsor's protocol ID
- HERACLES-HFpEF
- Acronym
- HERACLES-HFpEF
- Status last verified
- Apr 2021
- First submitted
- 1 Mar 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data will be made available on reasonable cooperation request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04782908
- Acronym / sponsor ID
- HERACLES-HFpEF / HERACLES-HFpEF
- Conditions
- Congestive Heart Failure, Tricuspid Regurgitation
- Keywords
- Heart failure with preserved ejection fraction, tricuspid regurgitation, transcatheter tricuspid valve edge-to-edge repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Mar 2021 (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 aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients undergoing transcatheter tricuspid valve edge-to-edge repair will undergo multimodal cardiovascular diagnostics before and after tricuspid valve repair including pressure volume loop analysis and cardiac magnetic resonance imaging
| Arm | Type | Receives |
|---|---|---|
| Transcatheter tricuspid valve edge-to-edge repair | Experimental | Device: Transcatheter tricuspid valve edge-to-edge repairPatients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
- Signs and symptoms of left-sided heart failure.
- Left-ventricular ejection fraction ≥50%
- Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure [PCWP] or left-ventricular end-diastolic pressure ≥15 mmHg)
Key exclusion criteria (5 listed)
- Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
- Moderate aortic stenosis.
- Pregnancy
- Contraindication to perform cardiac magnetic resonance imaging.
- Conditions rendering patient unable to give informed consent to the study protocol.
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 |
|---|---|---|
| Transcatheter tricuspid valve edge-to-edge repairTranscatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation. | Device | Transcatheter tricuspid valve edge-to-edge repair |
Primary outcome
Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
Time frame: Periprocedural.
Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.
4 secondary outcomes
Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR)
Time frame: Periprocedural.
Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.
Time frame: Periprocedural.
Change in dPdtmin
Time frame: Periprocedural.
Change in the early diastolic filling pattern as assessed by MRI.
Time frame: Baseline and 1-month follow-up following TTVR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided. Anonymized data will be made available on reasonable cooperation request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter tricuspid valve edge-to-edge repair in people with Congestive Heart Failure and Tricuspid Regurgitation, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
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 4 inclusion and 5 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 19 Apr 2021. 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 Germany. 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 Karl-Patrik Kresoja, MD (0341865252596, karl-patrik.kresoja@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprocedural change in enddiastolic pressure volume relationship of the left ventricle (time frame: Periprocedural.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2021.