Pulmonary HypertensionNCT06568952
Right Ventricular Function in Patients Taking Carfilzomib
An observational study of Pulmonary Hypertension, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2024to 30 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with multiple myeloma treated with carfilzomib
Who may be able to join
- Patients treated for multiple myeloma with carfilzomib
- Patients with echocardiogram before and under treatment.
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right Ventricular Function of Patients With Multiple Myeloma Treated With Carfilzomib
Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.
Read the detailed description
Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.
Patients had a cardiac ultrasound scan prior to the introduction of carfilzomib and an ultrasound scan following the introduction of carfilzomib. We will look at the evolution of right ventricular function parameters in these patients.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
tricuspid annular plane systolic excursion
measurement of tricuspid annular plane systolic excursion by echocardiography
Measured: 6 months after carfilzomib treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start30 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Valentin, MD, Principal investigator, Université de Lorraine, Département de Pneumologie, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568952
- Sponsor's protocol ID
- 2023PI0512
- Status last verified
- Dec 2023
- First submitted
- 20 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Function of Patients With Multiple Myeloma Treated With Carfilzomib
- ClinicalTrials.gov ID
- NCT06568952
- Acronym / sponsor ID
- 2023PI0512
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 23 Aug 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 treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.
Detailed description
Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.
Patients had a cardiac ultrasound scan prior to the introduction of carfilzomib and an ultrasound scan following the introduction of carfilzomib. We will look at the evolution of right ventricular function parameters in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with multiple myeloma treated with carfilzomib
Key inclusion criteria (2 listed)
- Patients treated for multiple myeloma with carfilzomib
- Patients with echocardiogram before and under treatment.
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tricuspid annular plane systolic excursion
Time frame: 6 months after carfilzomib treatment
measurement of tricuspid annular plane systolic excursion by echocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Simon Valentin, MD principal investigator
Université de Lorraine, Département de Pneumologie, CHRU NANCY
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 Pulmonary Hypertension, run by Central Hospital, Nancy, France at 1 site in France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 23 Aug 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tricuspid annular plane systolic excursion (time frame: 6 months after carfilzomib treatment). 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 23 Aug 2024.