Aortic StenosisPhase 4DapaTAVINCT04696185
Dapagliflozin After Transcatheter Aortic Valve Implantation
A Phase 4 study testing Dapagliflozin 10 MG in people with Aortic Stenosis and Transcatether Aortic Valve Implantation, run by Spanish Society of Cardiology at 40 sites in Spain.
Trial summary
Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Transcatether Aortic Valve Implantation
- What is being tested?
- Dapagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,257 participants
- Where
- 40 sitesSpain
- Study dates
- 27 Jan 2021to 30 Dec 2024
- Phase
- Phase 4
- 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
Who may be able to join
- SEVERE AORTIC STENOSIS UNDERWENT TAVI
- PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:
- Left ventricular ejection fraction ≤ 40% or
- Diabetes mellitus or
- Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2
Who cannot join
- Known allergy or intolerance to SGLT2 inhibitors.
- Concomitant therapy with sulfonylurea or SGLT2 inhibitors..
- Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.
- An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.
- Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
- Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge.
Show all 9Show fewer
- Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year).
- Pregnant or breast-feeding patients
- Patients participating in other clinical trials.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Spain40 sites
Hospital Juan Canalejo
A Coruña
Hospital Universitario de Albacete
Albacete
Hospital General Universitario de Alicante
Alicante
Hospital Universitario de Cruces
Barakaldo
Centro Médico TEKNON
Barcelona
Hospital Clinic
Barcelona
Hospital de Bellvitge
Barcelona
Hospital German I Trias
Barcelona
Hospital Universitario Sant Pau
Barcelona
Hospital Universitario Vall D´Hebron
Barcelona
Hospital Puerta Del Mar
Cadiz
Hospital Reina Sofia
Córdoba
Hospital San Cecilio
Granada
Hospital Virgen de Las Nieves
Granada
Hospital Juan Ramón Jiménez
Huelva
Hospital Universitario de Jaen
Jaén
Hospital Universitario de León
León
Clinica La Luz
Madrid
Clinica Nuestra Señora de América de Madrid
Madrid
Fundación Jimenez Diaz
Madrid
Hospital 12 de Octubre
Madrid
Hospital Clínico San Carlos
Madrid
Hospital La Princesa
Madrid
Hospital Puerta de Hierro
Madrid
Hospital Ramón Y Cajal
Madrid
Hospital Universitario de Torrejón
Madrid
Hospital Virgen de La Victoria
Málaga
Hospital Universitario Central de Asturias
Oviedo
Hospital Son Espases
Palma de Mallorca
Hospital Universitario de Navarra
Pamplona
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Marqués de Valdecilla
Santander
Hospital Clínico de Santiago
Santiago de Compostela
Hospital Virgen Del Rocio
Seville
Hospital Clínico de Valencia
Valencia
Hospital La Fe
Valencia
Hospital Clinico Universitario de Valladolid
Valladolid
Hospital Álvaro Cunqueiro
Vigo
Hospital Miguel Servet
Zaragoza
About this study
Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI).
Read the detailed description
Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ≤ 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment with dapagliflozin 10 mg/day or no dapagliflozin (no placebo).
Only variables available during routine clinical practice will be collected and there will be no additional tests.
The incidence of clinical events and adherence to the dapagliflozin arm will be documented at 2 time-points (3 ± 1 months and 12 months) by phone calls and review of medical records.
- Being tested
- Dapagliflozin 10 MG
- Keywords
- Aortic Stenosis, TAVI, Dapagliflozin
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MGDrug
Dapagliflozin 10 mg (daily oral dose)
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg Receives: Drug: Dapagliflozin 10 MG |
| Standard care | No intervention | No SGLT-2 inhibitor therapy with dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)
All-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).
Measured: 1 year
Secondary outcomes (6)
Incidence rate all-cause mortality
All cause mortality
Measured: 1 year
Incidence rate of Cardiovascular death
Mortality secondary to cardiovascular cause
Measured: 1 year
Incidence rate of Hospitalization for Heart Failure
Heart Failure requiring hospital admission
Measured: 1 year
Incidence rate of Urgent Heart Failure visits
Urgent Heart Failure visit requiring intravenous therapy
Measured: 1 year
Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death
Composite of Heart Failure hospitalization or Cardiovascular death
Measured: 1 year
Total number of Heart Failure hospitalizations and Cardiovascular deaths
Total number of (first and recurrent) Heart Failure hospitalizations and Cardiovascular deaths
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start27 Jan 2021
- Primary completion29 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dapa-TAVI is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial. Patients being discharged after TAVI who meet all inclusion criteria, and none of the exclusion criteria, will be eligible for the enrollment. Patients will be 1:1 randomized to 1 of these 2 arms: * Intervention group: Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg. * Control group: no SGLT-2 inhibitor therapy with dapagliflozin.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Responsible party
- Principal investigator, SERGIO RAPOSEIRAS ROUBIN, Spanish Society of Cardiology
- Investigators
- EMAD ABU ASSI, PhD, MD, Study chair, University Hospital Alvaro Cunqueiro, Vigo, SpainBORJA IBAÑEZ, PhD, MD, Study director, Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain)SERGIO RAPOSEIRAS ROUBIN, PhD, MD, Principal investigator, University Hospital Alvaro Cunqueiro, Vigo, SpainIGANCIO AMAT SANTOS, PhD, MD, Principal investigator, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696185
- Sponsor's protocol ID
- SEC-DAPATAVI-2020
- Acronym
- DapaTAVI
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available to other researchers after ending the trial, prior to a formal request to the Executive Committee
Publications
Amat-Santos IJ, Sanchez-Luna JP, Abu-Assi E, Melendo-Viu M, Cruz-Gonzalez I, Nombela-Franco L, Munoz-Garci AJ, Blas SG, de la Torre Hernandez JM, Romaguera R, Sanchez-Recalde A, Diez-Gil JL, Lopez-Otero D, Gheorge L, Ibanez B, Iniguez-Romo A, Raposeiras-Roubin S; Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investigators. Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. Eur J Heart Fail. 2022 Mar;24(3):581-588. doi: 10.1002/ejhf.2370. Epub 2021 Nov 9.
PubMed 34693613Bonanad-Lozano C, Garcia Blas S, Amat-Santos I, Gonzalez-Manzanares R, Sanchis J, Lopez Otero D, Nombela Franco L, Gheorge L, Sanz-Sanchez J, Baladron Zorita C, Iniguez Romo A, Munoz Garcia AJ, Vilalta V, Ojeda S, Veiga Fernandez G, Cordoba Soriano JG, Cepas P, Sandin Rollan M, Rios XF, Palma-Carbajal R, Martin Reyes R, Romaguera R, Avanzas P, Franco-Pelaez JA, Martin Moreiras J, Gonzalez Juanatey JR, Tirado G, Calle G, Diez JL, Santos-Martinez S, Dominguez Erquicia P, Garcia EM, Fernandez-Nofrerias E, Lopez Pais J, Gonzalo N, Barri AG, Asmarats L, Lopez Perez M, Dominguez Rodriguez LM, Cobo M, Gonzalez Bermudez I, Garcia Alvarez A, Garcia Pavia P, Fuster V, Ibanez B, Raposeiras-Roubin S. Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. J Am Coll Cardiol. 2025 Oct 14;86(15):1128-1138. doi: 10.1016/j.jacc.2025.07.051.
PubMed 41062227Raposeiras-Roubin S, Amat-Santos IJ, Rossello X, Gonzalez Ferreiro R, Gonzalez Bermudez I, Lopez Otero D, Nombela-Franco L, Gheorghe L, Diez JL, Baladron Zorita C, Baz JA, Munoz Garcia AJ, Vilalta V, Ojeda-Pineda S, de la Torre Hernandez JM, Cordoba Soriano JG, Regueiro A, Bordes Siscar P, Salgado Fernandez J, Garcia Del Blanco B, Martin-Reyes R, Romaguera R, Moris C, Garcia Blas S, Franco-Pelaez JA, Cruz-Gonzalez I, Arzamendi D, Romero Rodriguez N, Diez-Del Hoyo F, Camacho Freire S, Bosa Ojeda F, Astorga Burgo JC, Molina Navarro E, Caballero Borrego J, Ruiz Quevedo V, Sanchez-Recalde A, Peral Disdier V, Alegria-Barrero E, Torres-Llergo J, Feltes G, Fernandez Diaz JA, Cuellas C, Jimenez Britez G, Sanchez-Rubio Lezcano J, Barreiro-Pardal C, Nunez-Gil I, Abu-Assi E, Iniguez-Romo A, Fuster V, Ibanez B; DapaTAVI Investigators. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025 Apr 10;392(14):1396-1405. doi: 10.1056/NEJMoa2500366. Epub 2025 Mar 29.
PubMed 40162639
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04696185
- Acronym / sponsor ID
- DapaTAVI / SEC-DAPATAVI-2020
- Keywords
- Aortic Stenosis, TAVI, Dapagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,257 participants (actual)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 6 Jan 2021 (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.
Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI).
Detailed description
Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ≤ 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment with dapagliflozin 10 mg/day or no dapagliflozin (no placebo).
Only variables available during routine clinical practice will be collected and there will be no additional tests.
The incidence of clinical events and adherence to the dapagliflozin arm will be documented at 2 time-points (3 ± 1 months and 12 months) by phone calls and review of medical records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Dapa-TAVI is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial. Patients being discharged after TAVI who meet all inclusion criteria, and none of the exclusion criteria, will be eligible for the enrollment. Patients will be 1:1 randomized to 1 of these 2 arms: * Intervention group: Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg. * Control group: no SGLT-2 inhibitor therapy with dapagliflozin.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: Dapagliflozin 10 MGSodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg |
| Standard care | No intervention | –No SGLT-2 inhibitor therapy with dapagliflozin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- SEVERE AORTIC STENOSIS UNDERWENT TAVI
- PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:
Key exclusion criteria (9 listed)
- Known allergy or intolerance to SGLT2 inhibitors.
- Concomitant therapy with sulfonylurea or SGLT2 inhibitors..
- Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.
- An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.
- Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
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 10 MGDapagliflozin 10 mg (daily oral dose) | Drug | Dapagliflozin |
Primary outcome
Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)
Time frame: 1 year
All-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).
6 secondary outcomes
Incidence rate all-cause mortality
Time frame: 1 year
Incidence rate of Cardiovascular death
Time frame: 1 year
Incidence rate of Hospitalization for Heart Failure
Time frame: 1 year
Incidence rate of Urgent Heart Failure visits
Time frame: 1 year
Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death
Time frame: 1 year
Total number of Heart Failure hospitalizations and Cardiovascular deaths
Time frame: 1 year
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 10 Jan 2025.
- Results publication: PubMed 34693613Amat-Santos IJ, Sanchez-Luna JP, Abu-Assi E, Melendo-Viu M, Cruz-Gonzalez I, Nombela-Franco L, Munoz-Garci AJ, Blas SG, de la Torre Hernandez JM, Romaguera R, Sanchez-Recalde A, Diez-Gil JL, Lopez-Otero D, Gheorge L, Ibanez B, Iniguez-Romo A, Raposeiras-Roubin S; Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investigators. Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. Eur J Heart Fail. 2022 Mar;24(3):581-588. doi: 10.1002/ejhf.2370. Epub 2021 Nov 9.
- Derived from this study: PubMed 41062227Bonanad-Lozano C, Garcia Blas S, Amat-Santos I, Gonzalez-Manzanares R, Sanchis J, Lopez Otero D, Nombela Franco L, Gheorge L, Sanz-Sanchez J, Baladron Zorita C, Iniguez Romo A, Munoz Garcia AJ, Vilalta V, Ojeda S, Veiga Fernandez G, Cordoba Soriano JG, Cepas P, Sandin Rollan M, Rios XF, Palma-Carbajal R, Martin Reyes R, Romaguera R, Avanzas P, Franco-Pelaez JA, Martin Moreiras J, Gonzalez Juanatey JR, Tirado G, Calle G, Diez JL, Santos-Martinez S, Dominguez Erquicia P, Garcia EM, Fernandez-Nofrerias E, Lopez Pais J, Gonzalo N, Barri AG, Asmarats L, Lopez Perez M, Dominguez Rodriguez LM, Cobo M, Gonzalez Bermudez I, Garcia Alvarez A, Garcia Pavia P, Fuster V, Ibanez B, Raposeiras-Roubin S. Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. J Am Coll Cardiol. 2025 Oct 14;86(15):1128-1138. doi: 10.1016/j.jacc.2025.07.051.
- Derived from this study: PubMed 40162639Raposeiras-Roubin S, Amat-Santos IJ, Rossello X, Gonzalez Ferreiro R, Gonzalez Bermudez I, Lopez Otero D, Nombela-Franco L, Gheorghe L, Diez JL, Baladron Zorita C, Baz JA, Munoz Garcia AJ, Vilalta V, Ojeda-Pineda S, de la Torre Hernandez JM, Cordoba Soriano JG, Regueiro A, Bordes Siscar P, Salgado Fernandez J, Garcia Del Blanco B, Martin-Reyes R, Romaguera R, Moris C, Garcia Blas S, Franco-Pelaez JA, Cruz-Gonzalez I, Arzamendi D, Romero Rodriguez N, Diez-Del Hoyo F, Camacho Freire S, Bosa Ojeda F, Astorga Burgo JC, Molina Navarro E, Caballero Borrego J, Ruiz Quevedo V, Sanchez-Recalde A, Peral Disdier V, Alegria-Barrero E, Torres-Llergo J, Feltes G, Fernandez Diaz JA, Cuellas C, Jimenez Britez G, Sanchez-Rubio Lezcano J, Barreiro-Pardal C, Nunez-Gil I, Abu-Assi E, Iniguez-Romo A, Fuster V, Ibanez B; DapaTAVI Investigators. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025 Apr 10;392(14):1396-1405. doi: 10.1056/NEJMoa2500366. Epub 2025 Mar 29.
- Individual participant dataSharing planned: Yes. All data will be available to other researchers after ending the trial, prior to a formal request to the Executive Committee
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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.
EMAD ABU ASSI, PhD, MD study chair
University Hospital Alvaro Cunqueiro, Vigo, Spain
BORJA IBAÑEZ, PhD, MD study director
Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain)
SERGIO RAPOSEIRAS ROUBIN, PhD, MD principal investigator
University Hospital Alvaro Cunqueiro, Vigo, Spain
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10 MG in people with Aortic Stenosis and Transcatether Aortic Valve Implantation, run by Spanish Society of Cardiology at 40 sites in Spain.
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 5 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: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence rate of the composite of all-cause mortality or worsening heart failure (HF) (time frame: 1 year). 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 NCT04696185, which also lists 3 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 10 Jan 2025.