Heart FailurePhase 4NCT06196177
Effects of Levosimendan on Cardiac Function After TAVR in Patients With Heart Failure
A Phase 4 study testing Levosimontane injection in people with Heart Failure and Aortic Stenosis, Severe, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve replacement (TAVR) has brought new hope for these patients, and since its birth in 2002, TAVR… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Heart Failure, Aortic Stenosis, Severe
- What is being tested?
- Levosimontane injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to Feb 2025
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female patients aged 65-85 years undergoing TAVR;
- Echocardiography diagnosed severe aortic valve stenosis with LVEF<0.4；
- Prior to the initiation of the study, the patients or their legal representatives signed the informed consent form.
Who cannot join
- Adverse reactions to levosimendan or other excipients;
- In addition to the aortic valve disease, still with cardiac mechanical obstructive diseases;
- Patients with severe hepatic and renal impairment (creatinine clearance <30ml/min);
- Patients with severe hypotension (SBP<90mmHg or DBP<60mmHg) and ventricular tachycardia, ventricular fibrillation, and frequent premature ventricular contractions.
- Severe complications occurred during TAVR.
- Are involved in other clinical studies
- Other clinically significant respiratory, digestive, hematological, infectious, immune, endocrine, neuropsychiatric, tumor diseases, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
QIlu hospital of shandong university
Jinan, Shandong, 250000
zeyuan mei, bachelor, 15662690509, 1124561015@qq.com
About this study
Official title: Regulation of Cardiac Function After TAVR in Patients With Severe Aortic Stenosis Combined With Cardiac Insufficiency: a Prospective, Single-center, Randomized Controlled Study
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve replacement (TAVR) has brought new hope for these patients, and since its birth in 2002, TAVR has been widely used internationally, and its safety and efficacy have been confirmed by several large, prospective, randomized controlled studies.
Levosimendan is a new type of positive inotropic drug. It not only enhances myocardial contractile force through calcium sensitization, but also activates K+ sensitive channel KATP on the membrane of vascular smooth muscle, relaxes the arteries and veins of the whole body, and reduces the front and back load of the heart, pulmonary vascular resistance and systemic vascular resistance. A series of studies suggested that for patients undergoing thoracotomy in various cardiac surgeries, regardless of whether the patients were accompanied by ventricular systolic dysfunction before surgery, the use of levosimendan resulted in significantly higher postoperative cardiac function and decreased mortality than the control group, and patients with preoperative LVEF < 40% benefited more.
At present, there are no studies to clarify the regulatory effect of levosimendan on cardiac function after TAVR in patients with severe aortic stenosis complicated with cardiac insufficiency. This is a randomized controlled study. On the basis of basic drug therapy, the treatment group was given levosimendan to analyze the regulatory effect of levosimendan on cardiac function after TAVR.
Read the detailed description
We plan to recruit 112 patients with severe aortic stenosis and cardiac insufficiency, which，after TAVR, were randomly divided into treatment group (56 cases, intravenous levosimendan) and control group (56 cases).
The treatment group was given levosimendan injection intravenously once: 12.5mg levosimendan injection was diluted to 50ml with 5% glucose injection, the initial pump speed was 2ml/h, and maintained for 24 hours.
In the process of drug q1h monitoring blood pressure. If the systolic blood pressure was lower than 90mmHg, the blood pressure was remeasured 5 minutes later. If the systolic blood pressure was still lower than 90mmHg, 10mg norepinephrine injection +45ml 5% glucose injection was given intravenously by micro pump, the initial 2ml/h. The blood pressure was monitored, and the pump speed was adjusted according to the blood pressure to maintain the systolic blood pressure at 90-110mmHg.
Preoperative and postoperative immediately, after 3 days and postoperative 1 month, electrocardiogram, echocardiography and venous blood. Three tubes of venous blood were collected each time, and each tube was sent to the laboratory department of Qilu Hospital for blood routine, liver and kidney function, blood biochemistry, NT-proBNP and troponin I detection. The remaining samples were destroyed immediately after detection. The results of 6-minute walk test and the incidence of cardiovascular events were recorded at 1 month after operation.
- Conditions
- Heart Failure, Aortic Stenosis, Severe
- Being tested
- Levosimontane injection
- Medical subject headings
- Heart Failure, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosimontane injectionDrug
Also called wen，yue
Levosimendan injection was given once intravenously with a micro-pump: 12.5mg levosimendan injection was diluted with 5% glucose injection to 50ml at the initial pump speed of 2ml/h for 24h.
| Study group | Role | What they receive |
|---|---|---|
| Levosimontane group | Experimental | name：Levosimendan injection dose：12.5mg；once；24h Receives: Drug: Levosimontane injection |
| control group | No intervention | blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction （one month after TAVR）
At 1-month follow-up, left ventricular ejection fraction was measured by echocardiography in patients with severe aortic stenosis complicated with heart failure after TAVR.
Measured: one month
Secondary outcomes (7)
Left ventricular size
At 1 month follow-up, the change of left ventricular size before and after TAVR.
Measured: one month
left ventricular wall thickness
At 1 month follow-up, the change of left ventricular wall thickness before and after TAVR.
Measured: one month
NT-proBNP
At 1 month follow-up, the change of NT-proBNP before and after TAVR.
Measured: one month
Left ventricular global long axis strain
At 1 month follow-up, the change of left ventricular global long axis strain before and after TAVR.
Measured: one month
aortic valve orifice area
At 1 month follow-up, the change of aortic valve orifice area before and after TAVR.
Measured: one month
The result of 6-minute walking experiment
The result of 6-minute walking experiment was analyzed 1 month after TAVR.
Measured: one month
Incidence of cardiovascular events
The incidence of cardiovascular disease was measured 1 month after TAVR.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Mar 2024
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Qilu Hospital of Shandong UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- guipeng an, M.D., Study director, Qilu hospital of Shan Dong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196177
- Sponsor's protocol ID
- KYLL-202309-008
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans to share data
Publications
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.
PubMed 16980116Jorgensen K, Bech-Hanssen O, Houltz E, Ricksten SE. Effects of levosimendan on left ventricular relaxation and early filling at maintained preload and afterload conditions after aortic valve replacement for aortic stenosis. Circulation. 2008 Feb 26;117(8):1075-81. doi: 10.1161/CIRCULATIONAHA.107.722868. Epub 2008 Feb 11.
PubMed 18268152
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Cardiac Function After TAVR in Patients With Severe Aortic Stenosis Combined With Cardiac Insufficiency: a Prospective, Single-center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06196177
- Acronym / sponsor ID
- KYLL-202309-008
- Conditions
- Heart Failure, Aortic Stenosis, Severe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 9 Jan 2024 (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.
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve replacement (TAVR) has brought new hope for these patients, and since its birth in 2002, TAVR has been widely used internationally, and its safety and efficacy have been confirmed by several large, prospective, randomized controlled studies.
Levosimendan is a new type of positive inotropic drug. It not only enhances myocardial contractile force through calcium sensitization, but also activates K+ sensitive channel KATP on the membrane of vascular smooth muscle, relaxes the arteries and veins of the whole body, and reduces the front and back load of the heart, pulmonary vascular resistance and systemic vascular resistance. A series of studies suggested that for patients undergoing thoracotomy in various cardiac surgeries, regardless of whether the patients were accompanied by ventricular systolic dysfunction before surgery, the use of levosimendan resulted in significantly higher postoperative cardiac function and decreased mortality than the control group, and patients with preoperative LVEF < 40% benefited more.
At present, there are no studies to clarify the regulatory effect of levosimendan on cardiac function after TAVR in patients with severe aortic stenosis complicated with cardiac insufficiency. This is a randomized controlled study. On the basis of basic drug therapy, the treatment group was given levosimendan to analyze the regulatory effect of levosimendan on cardiac function after TAVR.
Detailed description
We plan to recruit 112 patients with severe aortic stenosis and cardiac insufficiency, which，after TAVR, were randomly divided into treatment group (56 cases, intravenous levosimendan) and control group (56 cases).
The treatment group was given levosimendan injection intravenously once: 12.5mg levosimendan injection was diluted to 50ml with 5% glucose injection, the initial pump speed was 2ml/h, and maintained for 24 hours.
In the process of drug q1h monitoring blood pressure. If the systolic blood pressure was lower than 90mmHg, the blood pressure was remeasured 5 minutes later. If the systolic blood pressure was still lower than 90mmHg, 10mg norepinephrine injection +45ml 5% glucose injection was given intravenously by micro pump, the initial 2ml/h. The blood pressure was monitored, and the pump speed was adjusted according to the blood pressure to maintain the systolic blood pressure at 90-110mmHg.
Preoperative and postoperative immediately, after 3 days and postoperative 1 month, electrocardiogram, echocardiography and venous blood. Three tubes of venous blood were collected each time, and each tube was sent to the laboratory department of Qilu Hospital for blood routine, liver and kidney function, blood biochemistry, NT-proBNP and troponin I detection. The remaining samples were destroyed immediately after detection. The results of 6-minute walk test and the incidence of cardiovascular events were recorded at 1 month after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimontane group | Experimental | Drug: Levosimontane injectionname：Levosimendan injection dose：12.5mg；once；24h |
| control group | No intervention | –blank control |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged 65-85 years undergoing TAVR;
- Echocardiography diagnosed severe aortic valve stenosis with LVEF<0.4；
- Prior to the initiation of the study, the patients or their legal representatives signed the informed consent form.
Key exclusion criteria (7 listed)
- Adverse reactions to levosimendan or other excipients;
- In addition to the aortic valve disease, still with cardiac mechanical obstructive diseases;
- Patients with severe hepatic and renal impairment (creatinine clearance <30ml/min);
- Patients with severe hypotension (SBP<90mmHg or DBP<60mmHg) and ventricular tachycardia, ventricular fibrillation, and frequent premature ventricular contractions.
- Severe complications occurred during TAVR.
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 |
|---|---|---|
| Levosimontane injectionAlso: wen，yueLevosimendan injection was given once intravenously with a micro-pump: 12.5mg levosimendan injection was diluted with 5% glucose injection to 50ml at the initial pump speed of 2ml/h for 24h. | Drug | Levosimontane group |
Primary outcome
Left ventricular ejection fraction （one month after TAVR）
Time frame: one month
At 1-month follow-up, left ventricular ejection fraction was measured by echocardiography in patients with severe aortic stenosis complicated with heart failure after TAVR.
7 secondary outcomes
Left ventricular size
Time frame: one month
left ventricular wall thickness
Time frame: one month
NT-proBNP
Time frame: one month
Left ventricular global long axis strain
Time frame: one month
aortic valve orifice area
Time frame: one month
The result of 6-minute walking experiment
Time frame: one month
Incidence of cardiovascular events
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Results publication: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Results publication: PubMed 16980116Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.
- Results publication: PubMed 18268152Jorgensen K, Bech-Hanssen O, Houltz E, Ricksten SE. Effects of levosimendan on left ventricular relaxation and early filling at maintained preload and afterload conditions after aortic valve replacement for aortic stenosis. Circulation. 2008 Feb 26;117(8):1075-81. doi: 10.1161/CIRCULATIONAHA.107.722868. Epub 2008 Feb 11.
- Individual participant dataSharing planned: No. We have no plans to share data
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
guipeng an, M.D. study director
Qilu hospital of Shan Dong University
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 Levosimontane injection in people with Heart Failure and Aortic Stenosis, Severe, run by Qilu Hospital of Shandong University 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 3 inclusion and 7 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 3 Apr 2024. 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. 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 guipeng an, M.D. (18560086587, guipengan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction （one month after TAVR） (time frame: one month). 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 NCT06196177, which also lists 3 linked publications.
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 3 Apr 2024.