Aortic Valve StenosisPhase 4NCT04573049
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
A Phase 4 study testing Levosimendan in people with Aortic Valve Stenosis and Heart Failure, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Valve Stenosis, Heart Failure, Inotropic Agents
- What is being tested?
- Levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Dec 2022
- Phase
- Phase 4
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Severe aortic stenosis
- Mean transaortic gradient ≥ 40 mmHg(at rest or stress)
- Aortic peak velocity ≥ 4m/s;
- Arotic valve area <0.8 cm2 and/or aortic valve area index< 0.5cm2/m2
- Cardiac dysfunction
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- LVEF≤50% (estimated by Simpson)
- NT-proBNP≥1500ng/L；
- Symptoms of dyspnea and fatigue when at rest or after slight exertion (New York Heart Association ≥ Ⅲ -Ⅳ)
- Intermittant fluid retention and/or symptoms induced by low cardiac output at rest, but lack of hemodynamic instability
Who cannot join
- Decompensated acute cardiac failure due to hemodynamic instability
- A historty of torsade de points ventricular tachycardia
- Known allergic reaction or sensitivity to Levosimendan or excipients
- Received levosimendan within 1 week prior to the planned clinical trial
- Serum potassium < 3.5 mmol/L and > 5.5 mmol/L before the drug study
- Systolic blood pressure < 90mmHg at baseline
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- Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2.
- Unable to participate in study for being critically ill asssed by clinicians
- Other concomitant severe morbidities leading to poor prognosis and decreased mortality, such as malignant tumor and disease involving other vital organs; life expectancy less than 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jianhui Wang
Beijing, Beijing Municipality, 100037
Jianhui Wang, MD, 010-88398082, stewenwang@sina.com
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement
Read the detailed description
The number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. Levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. However, there is no specified study concentrated on the role of Levosimendan in surgical procedure such as transcathter aortic intervention. This double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of Levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. Therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative Levosimendan infusion.
- Conditions
- Aortic Valve Stenosis, Heart Failure, Inotropic Agents, Safety Issues, Effect of Drug, Cardiac Event
- Being tested
- Levosimendan, Placebo
- Keywords
- Aortic valve stenosis, Heart failure, Levosimendan, Transcatheter Aortic Valve Replacement, Effectiveness, Safety, NT-proBNP
- Medical subject headings
- Aortic Valve Stenosis, Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min levosimendan is given for 24 hours.
PlaceboOther
On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min 5% glucose infusion is given for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | Levosimendan 0.1µg/kg/min will last for 24h after the valve is released. Receives: Drug: Levosimendan |
| Placebo | Placebo comparator | 5% glucose 0.1µg/kg/min administration will continue for 24h after the valve is released. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of NT-proBNP level
Measured: day 1, day 3, day 5, month 1 and month 3
Secondary outcomes (6)
The change of CK-MB
Measured: day 1, day 3, day 5, month 1 and month 3
The change of c-TnI
Measured: day 1, day 3, day 5, month 1 and month 3
The change of left ventricular ejection fraction
It is evaluated by echcardiography.
Measured: day 1, day 3, day 5, month 1 and month 3
The change of left ventricular end-diastolic diameter
It is evaluated by echcardiography.
Measured: day 1, day 3, day 5, month 1 and month 3
The number of patients in need of secondary intra-operative vasoactive-inotropic substances
Vasoactive-inotropic substances include dobutamine, milrinone, epinephrine, dopamine and vasopressors.
Measured: Peri-operation
The incidence of postoperative kidney injury
The kidney injury will be assessed by the change of serum creatinine, urea nitrogen and cystatin C.
Measured: day 1, day 3, day 5, month 1 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- China International Medical Foundation
- Responsible party
- Principal investigator, Jianhui Wang, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573049
- Sponsor's protocol ID
- 2020-1357
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04573049
- Acronym / sponsor ID
- 2020-1357
- Conditions
- Aortic Valve Stenosis, Heart Failure, Inotropic Agents, Safety Issues, Effect of Drug, Cardiac Event
- Keywords
- Aortic valve stenosis, Heart failure, Levosimendan, Transcatheter Aortic Valve Replacement, Effectiveness, Safety, NT-proBNP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- China International Medical Foundation
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 Oct 2020 (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.
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement
Detailed description
The number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. Levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. However, there is no specified study concentrated on the role of Levosimendan in surgical procedure such as transcathter aortic intervention. This double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of Levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. Therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative Levosimendan infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: LevosimendanLevosimendan 0.1µg/kg/min will last for 24h after the valve is released. |
| Placebo | Placebo comparator | Other: Placebo5% glucose 0.1µg/kg/min administration will continue for 24h after the valve is released. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Severe aortic stenosis
- Cardiac dysfunction
Key exclusion criteria (9 listed)
- Decompensated acute cardiac failure due to hemodynamic instability
- A historty of torsade de points ventricular tachycardia
- Known allergic reaction or sensitivity to Levosimendan or excipients
- Received levosimendan within 1 week prior to the planned clinical trial
- Serum potassium < 3.5 mmol/L and > 5.5 mmol/L before the drug study
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 |
|---|---|---|
| LevosimendanOn the basis of routine care given by corresponding clinicians, 0.1µg/kg/min levosimendan is given for 24 hours. | Drug | Levosimendan |
| PlaceboOn the basis of routine care given by corresponding clinicians, 0.1µg/kg/min 5% glucose infusion is given for 24 hours. | Other | Placebo |
Primary outcome
The change of NT-proBNP level
Time frame: day 1, day 3, day 5, month 1 and month 3
6 secondary outcomes
The change of CK-MB
Time frame: day 1, day 3, day 5, month 1 and month 3
The change of c-TnI
Time frame: day 1, day 3, day 5, month 1 and month 3
The change of left ventricular ejection fraction
Time frame: day 1, day 3, day 5, month 1 and month 3
The change of left ventricular end-diastolic diameter
Time frame: day 1, day 3, day 5, month 1 and month 3
The number of patients in need of secondary intra-operative vasoactive-inotropic substances
Time frame: Peri-operation
The incidence of postoperative kidney injury
Time frame: day 1, day 3, day 5, month 1 and month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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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 Phase 4 study testing Levosimendan in people with Aortic Valve Stenosis and Heart Failure, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 10 inclusion and 9 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 5 Oct 2020. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jianhui Wang, MD (010-88398082, stewenwang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of NT-proBNP level (time frame: day 1, day 3, day 5, month 1 and month 3). 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 5 Oct 2020.