Heart Failure With Reduced Ejection FractionSAINTS-ANCT05299879
Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
An observational study of Heart Failure With Reduced Ejection Fraction, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
Trial summary
The purpose of the Screening for Advanced heart failure IN stable ouTpatientS (SAINTS) study is to determine the prevalence of advanced heart failure (HF) in symptomatic patients with HF and reduced left ventricular ejection fraction (HFrEF), corresponding to the New York Heart Association functional class II-III. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterization
- How many people
- 400 participants
- Where
- 6 sitesDenmark
- Study dates
- 24 Oct 2022to Dec 2025
- How long will I take part?
- 3 Months
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed in Danish HF clinics in the Copenhagen region.
Who may be able to join
- History of Chronic heart failure > 3 months
- Stable (no hospitalization last 3 months) NYHA functional class II-III
- HFrEF patients (Left ventricular ejection fraction (LVEF) ≤ 30%)
- On or attempted betablocker and Renin-Angiotensin System (RAS) inhibitor treatment
- Informed consent
Who cannot join
- Body Mass Index (BMI) > 40 kg/m2
- Chronic renal replacement therapy or estimated Glomerular Filtration Rate (eGFR) < 15 ml/min/1.73m2
- Cardiac Resynchronization Therapy (CRT) implantation < 3 months ago or planned CRT
- Severe primary valvular disease
- On waiting list for heart transplantation or referred for evaluation
- Cancer or other severe non-cardiac disease with estimated life expectancy less than 1 year
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Not yet recruiting
Bispebjerg-Frederiksberg Hospital
Copenhagen, 2400
Olav Wendelbo Nielsen, MD, ph.d, dr.med.
- Not yet recruiting
Amager/Hvidovre Hospital
Copenhagen, 2650
Morten Petersen, MD, ph.d
- Not yet recruiting
Herlev and Gentofte Hospital
Copenhagen, 2730
Morten Schou, MD, ph.d
- Recruiting
Glostrup Hospital
Glostrup Municipality, 2600
Anders Barasa, MD, ph.d
- Not yet recruiting
Nordsjællands Hospital Hillerød
Hillerød, 3400
Nis Stride, MD, ph.d
- Not yet recruiting
Zeeland University Hospital Roskilde
Roskilde, 4000
Nadia Dridi
About this study
Official title: Screening for Advanced Heart Failure IN Stable ouTpatientS (The SAINTS Study) - Early Identification of Advanced Heart Failure
The purpose of the Screening for Advanced heart failure IN stable ouTpatientS (SAINTS) study is to determine the prevalence of advanced heart failure (HF) in symptomatic patients with HF and reduced left ventricular ejection fraction (HFrEF), corresponding to the New York Heart Association functional class II-III.
Recognition of advanced HF is a challenge for physicians and under referral for advanced management is a considerable problem. There are excellent treatment options for patients with advanced HF, i.e. heart transplantation or left ventricular assist device (LVAD) implantation, and outcomes with these therapies are considerably better if patients are treated before irreversible end-organ damage occurs. International consensus highlights the importance of timely recognition and referral of these patients to advanced HF centers.
Read more
The investigators aim to screen patients with symptomatic HFrEF who are followed in Danish HF clinics in the Copenhagen region with echocardiography, cardiopulmonary exercise test, 6 minute walk test, and NT-proBNP. The investigators hypothesize that 20% of patients with symptomatic heart failure followed in HF clinics in the Copenhagen Region will fulfill the modified criteria for advanced HF from the HFA-ESC (primary end-point in the study)(Reference 1). Patients who are identified with advanced HF will be offered right heart catheterization, guided by ultrasound and inserted through the internal jugular vein, determining pulmonary capillary wedge pressure, cardiac index, central venous pressure, mean pulmonary artery pressure, and central venous oxygen saturation. Patients not fulfilling criteria for advanced HF will be offered right heart catheterization consecutively until 50 patients have been examined (this group will be a comparator group to the patients with advanced HF).
Patients identified with advanced HF will be offered listing for HTx or LVAD if an indication without a contraindication is present. Patients who fulfill the primary endpoint of modified HFA-ESC criteria for advanced HF, and are ineligible for, or unwilling to undergo HTx or LVAD implantation will be invited to participate in the SAINTS B study.
Read the detailed description
Number of patients and sample size More than 3000 patients are followed in the HF clinics on Zealand including the greater Copenhagen region. The investigators plan to include 400 patients in the primary outcome analysis (SAINTS A) and hypothesize that 20% will fulfill the modified criteria for advanced HF.
Statistical analysis Descriptive statistics will be reported as mean +/- standard deviation (SD) or median (interquartile range (IQR)) depending on distribution. Comparisons between groups at baseline will be performed by unpaired t-tests for normally distributed continuous variables, by the Mann-Whitney U test (Wilcoxon rank-sum) for non-normally distributed continuous variables and χ2 or Fisher's exact test for categorical variables.
The primary outcome will be analyzed as the proportion n (%) of included patients who fulfill the modified HFA-ESC criteria for advanced HF. As for secondary outcomes, the investigators will analyze the proportion n (%) of patients who within the first 3 months are; 1) offered heart transplant listing, 2) offered LVAD implantation, 3) listed for HTx and 4) undergoing LVAD implantation. Further, comparisons of invasive hemodynamics, CPET measures, 6MWT, QoL and NTproBNP levels between patients with and without advanced HF will be made using an unpaired t-test or the Mann-Whitney U test for non-normally distributed continuous variables.
- Being tested
- Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterization
- Keywords
- Advanced heart failure, Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterizationDiagnostic test
Screening for advanced HF with modified criteria from the Heart Failure Association of the European Society of Cardiology
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic patients with HFrEF corresponding to NYHA II-III | Not described Receives: Diagnostic Test: Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients screened who fulfill advanced HF criteria using a modified HFA-ESC definition
Modified HFA-ESC criteria for advanced HF defined as:
- LVEF ≤ 30% as estimated by echocardiography
AND
- Peak oxygen uptake (VO2peak) < 12 ml/kg/min (14 if on betablocker) with a Respiratory Exchange Ratio (RER) > 1.05 OR < 50% expected for age and gender OR 6 minute walk test (6MWT) distance < 300 meters
AND
- N-terminal pro B-type natriuretic peptide (NTproBNP) > 2000 pg / ml
Measured: At time of screening
Secondary outcomes (16)
Proportion of patients offered heart transplant listing < 3 months after primary outcome
Measured: 3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients offered LVAD implantation < 3 months after primary outcome
Measured: 3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients listed for heart transplantation < 3 months after primary outcome
Measured: 3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients undergoing LVAD implantation < 3 months after primary outcome
Measured: 3 months after meeting modified HFA-ESC criteria for advanced HF
Pulmonary capillary wedge pressure (PCWP) in mmHg compared between patients with, and without advanced HF
Measured during right heart catheterization
Measured: Within 30 days from screening
Cardiac index (CI) in l/min/m2 compared between patients with, and without advanced HF
Measured during right heart catheterization
Measured: Within 30 days from screening
Central venous pressure (CVP) in mmHg compared between patients with, and without advanced HF
Measured during right heart catheterization
Measured: Within 30 days from screening
Mean pulmonary artery pressure (mPAP) in mmHg compared between patients with, and without advanced HF
Measured during right heart catheterization
Measured: Within 30 days from screening
Central venous oxygen saturation in % compared between patients with, and without advanced HF
Measured during right heart catheterization
Measured: Within 30 days from screening
Peak oxygen uptake (VO2peak) in ml/kg/min compared between patients with, and without advanced HF
Measured during cardiopulmonary exercise test
Measured: At time of screening
Peak respiratory exhange ratio compared between patients with, and without advanced HF
The ratio between metabolic production of CO2 and the uptake of O2 measured during cardiopulmonary exercise test
Measured: At time of screening
Minute ventilation-to-carbon dioxide output slope (VE/VCO2) compared between patients with, and without advanced HF
The ratio between metabolic production of CO2 and the uptake of O2 measured during cardiopulmonary exercise test
Measured: At time of screening
Peak Borg scale score compared between patients with, and without advanced HF
The Borg scale score is a rating of perceived exertion on a scale from 6-20, with 6 representing at rest, and 20 the most strenuous exercise imaginable. Measured during cardiopulmonary exercise test
Measured: At time of screening
6 minute walk test compared between patients with, and without advanced HF
Measured: At screening
Quality of Life (Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: At screening
NT-proBNP compared between patients with, and without advanced HF
Measured: At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start24 Oct 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 400 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD, PhD, DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299879
- Sponsor's protocol ID
- RH-SAINTS-A
- Acronym
- SAINTS-A
- Status last verified
- Oct 2022
- First submitted
- 7 Mar 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Crespo-Leiro MG, Metra M, Lund LH, Milicic D, Costanzo MR, Filippatos G, Gustafsson F, Tsui S, Barge-Caballero E, De Jonge N, Frigerio M, Hamdan R, Hasin T, Hulsmann M, Nalbantgil S, Potena L, Bauersachs J, Gkouziouta A, Ruhparwar A, Ristic AD, Straburzynska-Migaj E, McDonagh T, Seferovic P, Ruschitzka F. Advanced heart failure: a position statement of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 Nov;20(11):1505-1535. doi: 10.1002/ejhf.1236. Epub 2018 Jul 17.
PubMed 29806100
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Advanced Heart Failure IN Stable ouTpatientS (The SAINTS Study) - Early Identification of Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT05299879
- Acronym / sponsor ID
- SAINTS-A / RH-SAINTS-A
- Keywords
- Advanced heart failure, Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Mar 2022 (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.
The purpose of the Screening for Advanced heart failure IN stable ouTpatientS (SAINTS) study is to determine the prevalence of advanced heart failure (HF) in symptomatic patients with HF and reduced left ventricular ejection fraction (HFrEF), corresponding to the New York Heart Association functional class II-III.
Recognition of advanced HF is a challenge for physicians and under referral for advanced management is a considerable problem. There are excellent treatment options for patients with advanced HF, i.e. heart transplantation or left ventricular assist device (LVAD) implantation, and outcomes with these therapies are considerably better if patients are treated before irreversible end-organ damage occurs. International consensus highlights the importance of timely recognition and referral of these patients to advanced HF centers.
The investigators aim to screen patients with symptomatic HFrEF who are followed in Danish HF clinics in the Copenhagen region with echocardiography, cardiopulmonary exercise test, 6 minute walk test, and NT-proBNP. The investigators hypothesize that 20% of patients with symptomatic heart failure followed in HF clinics in the Copenhagen Region will fulfill the modified criteria for advanced HF from the HFA-ESC (primary end-point in the study)(Reference 1). Patients who are identified with advanced HF will be offered right heart catheterization, guided by ultrasound and inserted through the internal jugular vein, determining pulmonary capillary wedge pressure, cardiac index, central venous pressure, mean pulmonary artery pressure, and central venous oxygen saturation. Patients not fulfilling criteria for advanced HF will be offered right heart catheterization consecutively until 50 patients have been examined (this group will be a comparator group to the patients with advanced HF).
Patients identified with advanced HF will be offered listing for HTx or LVAD if an indication without a contraindication is present. Patients who fulfill the primary endpoint of modified HFA-ESC criteria for advanced HF, and are ineligible for, or unwilling to undergo HTx or LVAD implantation will be invited to participate in the SAINTS B study.
Detailed description
Number of patients and sample size More than 3000 patients are followed in the HF clinics on Zealand including the greater Copenhagen region. The investigators plan to include 400 patients in the primary outcome analysis (SAINTS A) and hypothesize that 20% will fulfill the modified criteria for advanced HF.
Statistical analysis Descriptive statistics will be reported as mean +/- standard deviation (SD) or median (interquartile range (IQR)) depending on distribution. Comparisons between groups at baseline will be performed by unpaired t-tests for normally distributed continuous variables, by the Mann-Whitney U test (Wilcoxon rank-sum) for non-normally distributed continuous variables and χ2 or Fisher's exact test for categorical variables.
The primary outcome will be analyzed as the proportion n (%) of included patients who fulfill the modified HFA-ESC criteria for advanced HF. As for secondary outcomes, the investigators will analyze the proportion n (%) of patients who within the first 3 months are; 1) offered heart transplant listing, 2) offered LVAD implantation, 3) listed for HTx and 4) undergoing LVAD implantation. Further, comparisons of invasive hemodynamics, CPET measures, 6MWT, QoL and NTproBNP levels between patients with and without advanced HF will be made using an unpaired t-test or the Mann-Whitney U test for non-normally distributed continuous variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic patients with HFrEF corresponding to NYHA II-III | – | Diagnostic Test: Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterization |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in Danish HF clinics in the Copenhagen region.
Key inclusion criteria (5 listed)
- History of Chronic heart failure > 3 months
- Stable (no hospitalization last 3 months) NYHA functional class II-III
- HFrEF patients (Left ventricular ejection fraction (LVEF) ≤ 30%)
- On or attempted betablocker and Renin-Angiotensin System (RAS) inhibitor treatment
- Informed consent
Key exclusion criteria (6 listed)
- Body Mass Index (BMI) > 40 kg/m2
- Chronic renal replacement therapy or estimated Glomerular Filtration Rate (eGFR) < 15 ml/min/1.73m2
- Cardiac Resynchronization Therapy (CRT) implantation < 3 months ago or planned CRT
- Severe primary valvular disease
- On waiting list for heart transplantation or referred for evaluation
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 |
|---|---|---|
| Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterizationScreening for advanced HF with modified criteria from the Heart Failure Association of the European Society of Cardiology | Diagnostic test | Symptomatic patients with HFrEF corresponding to NYHA II-III |
Primary outcome
Proportion of patients screened who fulfill advanced HF criteria using a modified HFA-ESC definition
Time frame: At time of screening
Modified HFA-ESC criteria for advanced HF defined as: • LVEF ≤ 30% as estimated by echocardiography AND • Peak oxygen uptake (VO2peak) < 12 ml/kg/min (14 if on betablocker) with a Respiratory Exchange Ratio (RER) > 1.05 OR < 50% expected for age and gender OR 6 minute walk test (6MWT) distance < 300 meters AND • N-terminal pro B-type natriuretic peptide (NTproBNP) > 2000 pg / ml
16 secondary outcomes
Proportion of patients offered heart transplant listing < 3 months after primary outcome
Time frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients offered LVAD implantation < 3 months after primary outcome
Time frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients listed for heart transplantation < 3 months after primary outcome
Time frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients undergoing LVAD implantation < 3 months after primary outcome
Time frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
Pulmonary capillary wedge pressure (PCWP) in mmHg compared between patients with, and without advanced HF
Time frame: Within 30 days from screening
Cardiac index (CI) in l/min/m2 compared between patients with, and without advanced HF
Time frame: Within 30 days from screening
Central venous pressure (CVP) in mmHg compared between patients with, and without advanced HF
Time frame: Within 30 days from screening
Mean pulmonary artery pressure (mPAP) in mmHg compared between patients with, and without advanced HF
Time frame: Within 30 days from screening
Central venous oxygen saturation in % compared between patients with, and without advanced HF
Time frame: Within 30 days from screening
Peak oxygen uptake (VO2peak) in ml/kg/min compared between patients with, and without advanced HF
Time frame: At time of screening
Peak respiratory exhange ratio compared between patients with, and without advanced HF
Time frame: At time of screening
Minute ventilation-to-carbon dioxide output slope (VE/VCO2) compared between patients with, and without advanced HF
Time frame: At time of screening
Peak Borg scale score compared between patients with, and without advanced HF
Time frame: At time of screening
6 minute walk test compared between patients with, and without advanced HF
Time frame: At screening
Quality of Life (Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: At screening
NT-proBNP compared between patients with, and without advanced HF
Time frame: At screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 29806100Crespo-Leiro MG, Metra M, Lund LH, Milicic D, Costanzo MR, Filippatos G, Gustafsson F, Tsui S, Barge-Caballero E, De Jonge N, Frigerio M, Hamdan R, Hasin T, Hulsmann M, Nalbantgil S, Potena L, Bauersachs J, Gkouziouta A, Ruhparwar A, Ristic AD, Straburzynska-Migaj E, McDonagh T, Seferovic P, Ruschitzka F. Advanced heart failure: a position statement of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 Nov;20(11):1505-1535. doi: 10.1002/ejhf.1236. Epub 2018 Jul 17.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
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.
Finn Gustafsson, MD, PhD, DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
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 6 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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 Finn Gustafsson, MD, PhD, DMSci (+45 35459743, finng@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients screened who fulfill advanced HF criteria using a modified HFA-ESC definition (time frame: At time of screening). 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 NCT05299879, which also lists 1 linked publication.
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 1 Nov 2022.