Pulmonary HypertensionPhase 1NCT06612086
Dapagliflozin in Mangement of Pulmonary Hypertension Patients
A Phase 1 study testing Dapagliflozin (Forxiga) in people with Pulmonary Hypertension, run by Assiut University at 1 site in Egypt.
Trial summary
Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Dapagliflozin (Forxiga)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2024to 10 Oct 2026
- Phase
- Phase 1
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- that the patients were diagnosed with pulmonary hypertension By Right heart cath OR suspected By Echocardiograghy according to the ESC guidelines for pulmonary hypertension that they were aged 18 years or older
Who cannot join
- symptomatic hypotension (systolic blood pressure \< 95 mmHg)
- impaired renal function (eGFR \< 30 mL/min/1.73 m2 calculated according to the CKD-EPI formula) and serum potassium level \> 5.2 mmol/L
- hepatic dysfunction (defined as liver parameters such as ALT, AST, and/or ALP, which are three times above the upper 99-th percentile of the reference range
- biliary cirrhosis and cholestasis, active malignancies (regardless of the stage and type of malignancy)),
- the current use of hormone replacement therapy, chemotherapy, or immunotherapy
- Type 1 diabetes mellitus
Show all 9Show fewer
- Acute pulmonary embolism (15)
- Signficant Primary valvular Heart disease
- Ischemic heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Dapagliflozin in Mangement of Pulmonary Hypertension Patients
Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.
Read the detailed description
Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions and may be associated with a variety of cardiovascular and respiratory diseases. It is clinically diagnosed by a resting mean pulmonary arterial pressure (mPAP) exceeding 20 mmHg . At present, PH\'s prevalence is approximated at 1 % of the global population and increases to 10 % for individuals over 65 years old, with considerable morbidity and mortality. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have emerged a metabolic dysfunction and exert cardioprotective effects. DELIVER randomized trials have shown that ( dapagliflozin) can reduce all-cause mortality and hospitalizations due to HF in patients with HF with a mildly reduced or preserved LV function .
The beneficial effects of SGLT2i on the left ventricular systolic and diastolic function, and functional symptom burden have been demonstrated in several studies, but not much is known about the effects of these drugs on the right ventricular (RV) systolic function . The RV is often neglected because of its complex anatomy and the difficulty of obtaining satisfactory imaging "windows" in daily practice . However, the RV has been shown to play an important prognostic role following cardiac surgery and in patients with HF, pulmonary arterial hypertension, or ischemic heart disease . In clinical practice, the assessment of the RV function is usually undertaken by measuring only the longitudinal systolic function, as reflected in the measurement of the tricuspid annular plane systolic excursion (TAPSE) and tricuspid lateral annular systolic velocity (s' wave) derived from Doppler tissue imaging. The fractional area change (FAC), on the other hand, gives us an insight into the radial contraction of the RV [8]. Because these parameters are load- and angle-dependent, advanced echocardiographic methods, such as speckle-tracking echocardiography (STE) measuring the longitudinal strain of the RV free wall (RV FWS) , have recently emerged as more accurate estimates of the RV systolic function . TAPSE and s' wave measure only the longitudinal RV function in the basal region of the RV free wall and were shown to be an independent predictor of cardiac death and major adverse cardiovascular events (MACE) in patients with diverse cardiovascular diseases. Furthermore, the ratio between the TAPSE and systolic pulmonary artery pressure (SPAP) represents the non-invasive measurement of the right ventriculo-arterial coupling and the RV contractile function.
For these reasons, Investigators designed the present study to investigate the effects of SGLT2 espacially dapagliflozin on the RV systolic function after it was added to optimal medical therapy (OMT) on the patient with pulmonary hypertension
- Conditions
- Pulmonary Hypertension
- Being tested
- Dapagliflozin (Forxiga)
- Keywords
- Dapagliflozin, pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (Forxiga)Drug
we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient
| Study group | Role | What they receive |
|---|---|---|
| we follow up patient who take Dapagliflozin in patient with pulmonary hypertension | Experimental | we follow up patient who take Dapagliflozin in patient with pulmonary hypertension Receives: Drug: Dapagliflozin (Forxiga) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dapagliflozin on Right ventricle systolic function in patient with pulmonary Hypertension by speckle tract Echocardiography(RV Strain )
patients with pulmonary hypertension , conventional parameters of RV systolic function, including TAPSE, FAC, s', and RVEF, may be normal despite abnormal RV strain, which is an additional reason for the usage of RV strain in these patients. RV longitudinal strain can identify subclinical RV dysfunction at the early phase of disease and may serve as an important marker of subtle RV systolic dysfunction when conventional parameters, primarily TAPSE, are in the normal range (25, 26).so investigator use RV strain to compare between RV function before and after taking of dapagliflozin
Measured: 6 month
Secondary outcomes (1)
Effect of Dapagliflozin on Quality of life for patient with pulmonary hypertension by Kansas City Cardiomyopathy Questionnaire Score
Quality of the life by Kansas City Cardiomyopathy Questionnaire Score score assess quality of life of patient , investigator used score to compare quality of life before and after taking Dapagliflozin this score are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to100: good to excellent.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start25 Oct 2024 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wessam sherif shokry zaki, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612086
- Sponsor's protocol ID
- Dapagliflozin in PH
- Status last verified
- Oct 2024
- First submitted
- 21 Sep 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kohler S, Zeller C, Iliev H, Kaspers S. Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials. Adv Ther. 2017 Jul;34(7):1707-1726. doi: 10.1007/s12325-017-0573-0. Epub 2017 Jun 19.
PubMed 28631216Wang A, Yang K, Wang T, Zhang N, Tang H, Feng X. Effects of sodium-glucose cotransporter 2 inhibitors on risk of venous thromboembolism in patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2020 Jan;36(1):e3174. doi: 10.1002/dmrr.3174. Epub 2019 May 27.
PubMed 31050384Reddy YNV, Carter RE, Sorimachi H, Omar M, Popovic D, Alogna A, Jensen MD, Borlaug BA. Dapagliflozin and Right Ventricular-Pulmonary Vascular Interaction in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):843-851. doi: 10.1001/jamacardio.2024.1914.
PubMed 39046727Li H, Zhang Y, Wang S, Yue Y, Liu Q, Huang S, Peng H, Zhang Y, Zeng W, Wu Z. Dapagliflozin has No Protective Effect on Experimental Pulmonary Arterial Hypertension and Pulmonary Trunk Banding Rat Models. Front Pharmacol. 2021 Nov 1;12:756226. doi: 10.3389/fphar.2021.756226. eCollection 2021.
PubMed 34790128Mustapic I, Bakovic D, Susilovic Grabovac Z, Borovac JA. Impact of SGLT2 Inhibitor Therapy on Right Ventricular Function in Patients with Heart Failure and Reduced Ejection Fraction. J Clin Med. 2022 Dec 21;12(1):42. doi: 10.3390/jcm12010042.
PubMed 36614843Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.
PubMed 36027570Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.
PubMed 34449189
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dapagliflozin in Mangement of Pulmonary Hypertension Patients
- ClinicalTrials.gov ID
- NCT06612086
- Acronym / sponsor ID
- Dapagliflozin in PH
- Conditions
- Pulmonary Hypertension
- Keywords
- Dapagliflozin, pulmonary hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 25 Sep 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.
Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.
Detailed description
Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple clinical conditions and may be associated with a variety of cardiovascular and respiratory diseases. It is clinically diagnosed by a resting mean pulmonary arterial pressure (mPAP) exceeding 20 mmHg . At present, PH\'s prevalence is approximated at 1 % of the global population and increases to 10 % for individuals over 65 years old, with considerable morbidity and mortality. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have emerged a metabolic dysfunction and exert cardioprotective effects. DELIVER randomized trials have shown that ( dapagliflozin) can reduce all-cause mortality and hospitalizations due to HF in patients with HF with a mildly reduced or preserved LV function .
The beneficial effects of SGLT2i on the left ventricular systolic and diastolic function, and functional symptom burden have been demonstrated in several studies, but not much is known about the effects of these drugs on the right ventricular (RV) systolic function . The RV is often neglected because of its complex anatomy and the difficulty of obtaining satisfactory imaging "windows" in daily practice . However, the RV has been shown to play an important prognostic role following cardiac surgery and in patients with HF, pulmonary arterial hypertension, or ischemic heart disease . In clinical practice, the assessment of the RV function is usually undertaken by measuring only the longitudinal systolic function, as reflected in the measurement of the tricuspid annular plane systolic excursion (TAPSE) and tricuspid lateral annular systolic velocity (s' wave) derived from Doppler tissue imaging. The fractional area change (FAC), on the other hand, gives us an insight into the radial contraction of the RV [8]. Because these parameters are load- and angle-dependent, advanced echocardiographic methods, such as speckle-tracking echocardiography (STE) measuring the longitudinal strain of the RV free wall (RV FWS) , have recently emerged as more accurate estimates of the RV systolic function . TAPSE and s' wave measure only the longitudinal RV function in the basal region of the RV free wall and were shown to be an independent predictor of cardiac death and major adverse cardiovascular events (MACE) in patients with diverse cardiovascular diseases. Furthermore, the ratio between the TAPSE and systolic pulmonary artery pressure (SPAP) represents the non-invasive measurement of the right ventriculo-arterial coupling and the RV contractile function.
For these reasons, Investigators designed the present study to investigate the effects of SGLT2 espacially dapagliflozin on the RV systolic function after it was added to optimal medical therapy (OMT) on the patient with pulmonary hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.
| Arm | Type | Receives |
|---|---|---|
| we follow up patient who take Dapagliflozin in patient with pulmonary hypertension | Experimental | Drug: Dapagliflozin (Forxiga)we follow up patient who take Dapagliflozin in patient with pulmonary hypertension |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- that the patients were diagnosed with pulmonary hypertension By Right heart cath OR suspected By Echocardiograghy according to the ESC guidelines for pulmonary hypertension that they were aged 18 years or older
Key exclusion criteria (9 listed)
- symptomatic hypotension (systolic blood pressure \< 95 mmHg)
- impaired renal function (eGFR \< 30 mL/min/1.73 m2 calculated according to the CKD-EPI formula) and serum potassium level \> 5.2 mmol/L
- hepatic dysfunction (defined as liver parameters such as ALT, AST, and/or ALP, which are three times above the upper 99-th percentile of the reference range
- biliary cirrhosis and cholestasis, active malignancies (regardless of the stage and type of malignancy)),
- the current use of hormone replacement therapy, chemotherapy, or immunotherapy
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 |
|---|---|---|
| Dapagliflozin (Forxiga)we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient | Drug | we follow up patient who take Dapagliflozin in patient with pulmonary hypertension |
Primary outcome
Effect of Dapagliflozin on Right ventricle systolic function in patient with pulmonary Hypertension by speckle tract Echocardiography(RV Strain )
Time frame: 6 month
patients with pulmonary hypertension , conventional parameters of RV systolic function, including TAPSE, FAC, s', and RVEF, may be normal despite abnormal RV strain, which is an additional reason for the usage of RV strain in these patients. RV longitudinal strain can identify subclinical RV dysfunction at the early phase of disease and may serve as an important marker of subtle RV systolic dysfunction when conventional parameters, primarily TAPSE, are in the normal range (25, 26).so investigator use RV strain to compare between RV function before and after taking of dapagliflozin
1 secondary outcome
Effect of Dapagliflozin on Quality of life for patient with pulmonary hypertension by Kansas City Cardiomyopathy Questionnaire Score
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 28631216Kohler S, Zeller C, Iliev H, Kaspers S. Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials. Adv Ther. 2017 Jul;34(7):1707-1726. doi: 10.1007/s12325-017-0573-0. Epub 2017 Jun 19.
- Background: PubMed 31050384Wang A, Yang K, Wang T, Zhang N, Tang H, Feng X. Effects of sodium-glucose cotransporter 2 inhibitors on risk of venous thromboembolism in patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2020 Jan;36(1):e3174. doi: 10.1002/dmrr.3174. Epub 2019 May 27.
- Results publication: PubMed 39046727Reddy YNV, Carter RE, Sorimachi H, Omar M, Popovic D, Alogna A, Jensen MD, Borlaug BA. Dapagliflozin and Right Ventricular-Pulmonary Vascular Interaction in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):843-851. doi: 10.1001/jamacardio.2024.1914.
- Results publication: PubMed 34790128Li H, Zhang Y, Wang S, Yue Y, Liu Q, Huang S, Peng H, Zhang Y, Zeng W, Wu Z. Dapagliflozin has No Protective Effect on Experimental Pulmonary Arterial Hypertension and Pulmonary Trunk Banding Rat Models. Front Pharmacol. 2021 Nov 1;12:756226. doi: 10.3389/fphar.2021.756226. eCollection 2021.
- Results publication: PubMed 36614843Mustapic I, Bakovic D, Susilovic Grabovac Z, Borovac JA. Impact of SGLT2 Inhibitor Therapy on Right Ventricular Function in Patients with Heart Failure and Reduced Ejection Fraction. J Clin Med. 2022 Dec 21;12(1):42. doi: 10.3390/jcm12010042.
- Results publication: PubMed 36027570Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.
- Results publication: PubMed 34449189Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapagliflozin (Forxiga) in people with Pulmonary Hypertension, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 9 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 29 Oct 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 Egypt. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Effect of Dapagliflozin on Right ventricle systolic function in patient with pulmonary Hypertension by speckle tract Echocardiography(RV Strain ) (time frame: 6 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 NCT06612086, which also lists 7 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 29 Oct 2024.