Heart Transplant FailureNCT06140810
Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation
An observational study of Heart Transplant Failure and Anesthesia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplant Failure, Anesthesia
- What is being tested?
- Lung Recruitment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 1 Nov 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a study in patients following orthotropic heart transplantation meeting the inclusion exclusion criteria.
Who may be able to join
- Patients having undergone orthotropic heart transplantation
- Patients requiring routine heart catheterization for post-transplant surveillance
- General anesthesia
Who cannot join
- Patient/parental refusal
- Patients with suspected or known acute rejection
- Known anti-rejection medication non-compliance
- Patients within 1 year following heart transplant
- Home oxygen requirement
- Previous lung surgery (e.g., lobectomy) other than biopsy
Show all 12Show fewer
- Lung transplantation
- Known pulmonary fibrosis
- Known pulmonary hypertension (>1/2 systemic)
- Sedation without the use of an airway device
- Active respiratory infection -Inability to provide recruitment breaths >25mmHg -Cardiomegaly
- Recipient/donor size mismatch
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Childrens Hospital
Houston, Texas, 77030
Adam Adler, MD, 832-824-5800, adam.adler@bcm.edu
About this study
Official title: Impact of Atelectasis and Lung Recruitment on RVEDP Measurement in Children Undergoing Cardiac Catheterization for Surveillance Following Orthotropic Heart Transplantation
Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.
Read the detailed description
Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). Atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. Therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.
- Conditions
- Heart Transplant Failure, Anesthesia
- Being tested
- Lung Recruitment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung RecruitmentOther
Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular End diastolic pressure | Measurement of pre and post recruitment right ventricular end diastolic pressure Receives: Other: Lung Recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater
Change of the right ventricular end diastolic pressure from pre and post recruitment breaths
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start20 Nov 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant FailureStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Adler MD, MS, FAAP, Baylor College of Medicine
- Investigators
- adam adker, MD, Principal investigator, Texas Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140810
- Sponsor's protocol ID
- H52547
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be made available upon written request
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Atelectasis and Lung Recruitment on RVEDP Measurement in Children Undergoing Cardiac Catheterization for Surveillance Following Orthotropic Heart Transplantation
- ClinicalTrials.gov ID
- NCT06140810
- Acronym / sponsor ID
- H52547
- Conditions
- Heart Transplant Failure, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 20 Nov 2023 (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.
Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.
Detailed description
Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). Atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. Therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right ventricular End diastolic pressure | – | Other: Lung RecruitmentMeasurement of pre and post recruitment right ventricular end diastolic pressure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a study in patients following orthotropic heart transplantation meeting the inclusion exclusion criteria.
Key inclusion criteria (3 listed)
- Patients having undergone orthotropic heart transplantation
- Patients requiring routine heart catheterization for post-transplant surveillance
- General anesthesia
Key exclusion criteria (12 listed)
- Patient/parental refusal
- Patients with suspected or known acute rejection
- Known anti-rejection medication non-compliance
- Patients within 1 year following heart transplant
- Home oxygen requirement
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 |
|---|---|---|
| Lung RecruitmentLung Recruitment will be performed during general anesthesia to reduce areas of atelectasis | Other | Right ventricular End diastolic pressure |
Primary outcome
Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater
Time frame: 10 minutes
Change of the right ventricular end diastolic pressure from pre and post recruitment breaths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: Undecided. De-identified data will be made available upon written 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.
adam adker, MD principal investigator
Texas Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Failure and Anesthesia, run by Baylor College of Medicine at 1 site in United States.
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 12 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 21 Dec 2023. 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 United States. 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 Adam Adler, MD (8328245800, adam.adler@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater (time frame: 10 minutes). 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 21 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.