UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055585 |
|---|---|
| Receipt number | R000063522 |
| Scientific Title | Impact of inhaled nitric oxide therapy in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation combined with Impella |
| Date of disclosure of the study information | 2024/09/22 |
| Last modified on | 2024/09/22 20:37:43 |
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Basic information
Public title
Impact of inhaled nitric oxide therapy in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation combined with Impella
Acronym
Impact of inhaled nitric oxide therapy in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation combined with Impella
Scientific Title
Impact of inhaled nitric oxide therapy in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation combined with Impella
Scientific Title:Acronym
Impact of inhaled nitric oxide therapy in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation combined with Impella
Region
| Japan |
Condition
Condition
consecutive patients supported with ECPELLA for CS due to acute myocardial infarction (AMI) and non-compensated heart failure
Classification by specialty
| Cardiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Combination therapy with veno arterial extracorporeal membrane oxygenation and Impella has been recently proposed for patients with cardiogenic shock requiring mechanical circulatory support. This method has been reported to reduce myocardial damage and improve prognosis by alleviating the increased left ventricular afterload caused by retrograde blood flow with VA ECMO. ECPELLA has been reported to reduce 30 day mortality by 20% compared with VA ECMO alone, but the 30 days mortality rate remains high in patients treated with ECPELLA. Therefore, we believe that reducing the mortality of patients treated with ECPELLA is the future challenge that needs to be overcome to improve the prognosis of patients with CS. Inhaled nitric oxide is taken up transalveolarly into the pulmonary capillaries, making it possible to efficiently improve respiratory and right ventricular function without any hypotensive side effects in the systemic circulation. This is possible due to selective vasodilation of the pulmonary arteries by iNO and improvements in ventilatory blood flow ratio and intrapulmonary shunting. iNO has been reported to improve pediatric pulmonary artery hypertension and perioperative PAH in adult cardiac surgery. iNO has been used in pediatric and adult cardiac surgery for over three decades, but few reports have evaluated its efficacy in patients with CS requiring MCS. Early weaning from VA ECMO may be the first step toward reducing the mortality of ECPELLA patients. iNO therapy improves RV function by decreasing pulmonary arterial resistance, resulting in an increased Impella flow rate, which may facilitate early weaning from VA ECMO and improve survival. The purpose of this study is to investigate the prognostic and hemodynamic impact of iNO therapy in ECPELLA patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the comparison of 30-day all-cause mortality between patients with iNO and without iNO.
Key secondary outcomes
The secondary endpoints were comparisons of the VA-ECMO withdrawal rate and duration between patients with and without iNO therapy, as well as changes in hemodynamic- and MCS-related parameters after the initiation of iNO therapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study was a single center retrospective observational study and included consecutive patients supported with ECPELLA for CS due to acute myocardial infarction (AMI) and non-compensated heart failure at Kindai University Hospital from September 2019 to March 2024.
Key exclusion criteria
Under 20 years of age
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Gaku |
| Middle name | |
| Last name | Nakazawa |
Organization
Department of Medicine, Kindai University Faculty of Medicine
Division name
Division of Cardiology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osakasayama, Osaka, Japan, 589-8511
TEL
+81-72-366-0221
n.0609.yamada@gmail.com
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Yamada |
Organization
Department of Medicine, Kindai University Faculty of Medicine
Division name
Division of Cardiology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osakasayama, Osaka, Japan, 589-8511
TEL
+81-72-366-0221
Homepage URL
n.0609.yamada@gmail.com
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Nobuhiro Yamada
Funding Source
Organization
Kindai University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University
Address
377-2, Ohno-Higashi, Osakasayama, Osaka, Japan, 589-8511
Tel
+81-72-366-0221
n.0609.yamada@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
48
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively analyzed the data of consecutive patients with CS supported by ECPELLA from September 2019 to March 2024 at our hospital. Changes in pulmonary artery pulsatility index and Impella flow over time were evaluated, and VA-ECMO withdrawal rate, time to withdrawal, and 30 days survival were compared between ECPELLA patients with and without iNO therapy.
Management information
Registered date
| 2024 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063522
