UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054632 |
|---|---|
| Receipt number | R000062431 |
| Scientific Title | The effects of nitric oxide inhalation therapy on right heart function and pulmonary artery pressure in patients using IMPELLA. |
| Date of disclosure of the study information | 2024/06/11 |
| Last modified on | 2025/11/27 16:52:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of nitric oxide inhalation therapy on right heart function and pulmonary artery pressure in patients using IMPELLA.
Acronym
The effects of nitric oxide inhalation therapy on right heart function and pulmonary artery pressure in patients using IMPELLA.
Scientific Title
The effects of nitric oxide inhalation therapy on right heart function and pulmonary artery pressure in patients using IMPELLA.
Scientific Title:Acronym
The effects of nitric oxide inhalation therapy on right heart function and pulmonary artery pressure in patients using IMPELLA.
Region
| Japan |
Condition
Condition
heart failure, post cardiovascular surgery
Classification by specialty
| Cardiology | Vascular surgery | Anesthesiology |
| Cardiovascular surgery | Emergency medicine | Intensive care medicine |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inhaled nitric oxide therapy is a selective pulmonary artery vasodilator that has been reported to improve severe right heart failure in adult cases. In fact, improvement of pulmonary hypertension in the perioperative period of cardiac surgery is listed in the indications and indications section of the package insert. In recent years, the pump IMPELLA for assisted circulation has been used in cases of left heart failure refractory to medical therapy and in patients with difficulty weaning from cardiopulmonary ventricular support after cardiac surgery. In such cases, iNO is sometimes used. However, although there have been case reports of the efficacy of iNO in improving pulmonary hypertension and right heart failure when using IMPELLA, there are no reports of clinical studies involving multiple patients. The purpose of this study was to investigate the use of IMPELLA in the treatment of patients with HIV. The purpose of this study was to determine the effect of iNO on right heart function and pulmonary artery pressure in adults with severe heart failure and perioperative pulmonary hypertension during cardiac surgery on IMPELLA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pulmonary artery pressure before and 30 minutes and after administration of iNO
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A) Patients 18 years of age or older using IMPELLA for heart failure management or perioperative management of cardiac surgery, plus iNO
B) Patients may or may not be using a cardiopulmonary assist device VA-ECMO (Extracorporeal Cardiac Membrane Oxygenation).
C) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own or their family members' free will based on sufficient understanding.
Key exclusion criteria
Patients whthout pulmonary artery catheter, in coma, pregnant patients, patients with severe congenital heart disease, patients with prolonged loss of consciousness after cardiopulmonary arrest resuscitation, and other patients deemed ineligible for the study by the investigators will also be excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shuichiro |
| Middle name | |
| Last name | Kurita |
Organization
Niigata University advanced emergency medical center
Division name
Niigata University advanced emergency medical center
Zip code
9518520
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-223-6161
kuritashuichiro@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Shuichiro |
| Middle name | |
| Last name | Kurita |
Organization
Niigata University advanced emergency medical center
Division name
Niigata University advanced emergency medical center
Zip code
9518068
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
09039603692
Homepage URL
kuritashuichiro@hotmail.co.jp
Sponsor or person
Institute
Niigata university
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata university medical ethics comittie
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-223-6161
kuritashuichiro@hotmail.co.jp
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 | 06 | Month | 11 | 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
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 | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2024 | Year | 06 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062431
