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Heart FailurePhase 2NCT06012266

Repurposing Empagliflozin and Dapagliflozin for Paediatric Heart Failure: Translational Approach and Dose Rationale

A Phase 2 study testing Dapagliflozin tablet and Empagliflozin Tablets in people with Heart Failure, run by Centre Hospitalier Universitaire Vaudois at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims at exploring the use of Dapagliflozin and Empagliflozin in children and adolescents 6-18 years old with heart failure. These molecules are effective in reducing hospitalisations and mortality in adults with heart failure and are used in adolescents with type 2 diabetes mellitus, but little is known on… Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Heart Failure
What is being tested?
Dapagliflozin tablet and Empagliflozin Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesin 2 countries
Study dates
Aug 2024to Aug 2025
Phase
Phase 2
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 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children 6 to 18 years of age, followed either as in- or outpatients at the Heart failure unit, Great Ormond Street Hospital NHS Foundation Trust, London or at the Paediatric Cardiology Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne University Hospital, Lausanne, Switzerland will be eligible for inclusion.
  • Currently on heart failure medication (any drug or any combination).
  • Patients should potentially benefit from adding a SGLT2i (as judged by the treating physician and the local PI or Co-PI).
  • Patients need to be on stable medical treatment, defined as no new heart failure drug started over the preceding 2 weeks and no major drug dose modification (apart minor adaptations, like weight adaptations, rounding or formulation changes) during the 2 weeks prior to enrolment.
  • Adolescents, respectively parents or caregivers of children, capable of giving informed consent.

Who cannot join

  • Inability to understand and go through the informed consent procedure.
  • Inability to receive medications per os or through a nasogastric tube.
  • Patients on either Insulin or Metformin will be excluded from participation. This implies the exclusion of patients with Diabetes mellitus (either type 1 or type 2 or other rare forms) necessitating either insulin or metformin.
  • Type 1 Diabetes mellitus or any underlying metabolic disease associated with hypoglycaemias.
  • Body weight <13kg.
  • Current smokers (defined as >1 cigarette/week).
Show all 26Show fewer
  • Use of any other nicotine-delivering product (e.g. nicotine patches).
  • Any known illicit drug abuse.
  • Active chronic HBV, HCV or HIV.
  • Any major surgery within 4 weeks of first dose administration.
  • Blood transfusion recipient within 4 weeks of dose administration.
  • eGFR =<45mL/min/1.73m2 (simplified Schwartz formula).
  • K+ >6.5mmol/L.
  • Blood glucose <4mmol/L.
  • There are no blood pressure exclusion criteria foreseen, but participants need to be haemodynamically stable, as assessed by the local investigator (board-certified paediatric cardiologist).
  • Sustained or symptomatic arrhythmia insufficiently controlled with drug and/or device therapy.
  • Cardio-surgical procedure within the 2 months prior to Visit 1, or interventional cardiac catheterization within 2 weeks prior to Visit 1, or the patient is planned to undergo cardiac surgery or an interventional cardiac catheterization during the study period (i.e. in the 6 weeks following Visit 1).
  • Post-menarchal female patients of childbearing potential cannot be included.
  • Known lactose intolerance, galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
  • Known allergies to excipients of either Dapagliflozin or Empagliflozin.
  • Significant medical history of active severe medical disease.
  • Significant liver disease, Child Pugh Class C, or significant laboratory abnormalities at enrolment.
  • Significant gastroenterological or hepatic disease that could significantly impair absorption or metabolism of orally administered drugs.
  • Any medical co-morbidity, which is deemed incompatible (or only with relevant risk) with study participation by the treating clinician and/or the study investigator.
  • Active urinary tract infection (being treated with antibiotics at the moment of Visit 1) or other relevant bacterial infection, as judged by the treating clinician and/or the study investigator.
  • The patient is currently participating in another interventional clinical trial or has participated in such a trial during the <14 days before Visit 1 (or if enrolment in this study is incompatible with the protocol of that preceding trial).

Trial locations and contacts

3 sites in 2 countries.

Sebastiano A.G. Lava, MD MSc contact

+41 21 314 3556

webmaster@sebastianolava.ch

Craig Laurence, MD contact

craig.laurence@gosh.nhs.uk

3 sites in 2 countries

United Kingdom2 sites

  • University College London

    London, Greater London, WC1H 9JP

    Sebastiano A.G. Lava, MD MSc, webmaster@sebastianolava.ch

    Oscar Della Pasqua, MD PhD

  • Great Ormond Street Hospital NHS Foundation Trust

    London, Greater London, WC1N 3JH

    Craig Laurence, MD, craig.laurence@gosh.nhs.uk

    Sebastiano A.G. Lava, MD MSc, webmaster@sebastianolava.ch

Other trials in United Kingdom

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011

    Sebastiano A.G. Lava, MD MSC, +41 21 314 3556, webmaster@sebastianolava.ch

    Nicole Sekarski, MD, +41 21 314 3556

Other trials in Switzerland

About this study

Official title: Dose Rationale for Dapagliflozin and Empagliflozin in Paediatric Heart Failure: a Phase II.a Pharmacokinetics, Ease-of-swallow, Safety and Proof-of-concept Study Among Children 6-18 Years of Age

This study aims at exploring the use of Dapagliflozin and Empagliflozin in children and adolescents 6-18 years old with heart failure. These molecules are effective in reducing hospitalisations and mortality in adults with heart failure and are used in adolescents with type 2 diabetes mellitus, but little is known on children with heart failure. Particularly, the best dose to use in this population is currently unknown. This trial aims to:

  1. define a dose rationale for this indication and age group (pharmacokinetic study),
  2. assess and monitor safety,
  3. assess ease-of-swallow,
  4. explore middle-term (4-6 weeks) efficacy and efficacy markers.
Read more

Participants will be asked to attend 4 study visits over 4-6 weeks, and one end-study visit 2-12 weeks thereafter. Visits 1 and 3 will entail an 8h day-hospital stay, while Visits 2, 4 and the end-study visit will be outpatient clinics (approximately 2h). Participants will be asked to take the studied drug once daily during the 4-6 weeks of the study period.

All participants will take both Dapagliflozin and Empagliflozin: 6 will start with Dapagliflozin first (Visits 1-2) and then switch to Empagliflozin (Visits 3-4), while 6 will start with Empagliflozin first (Visits 1-2) and then switch to Dapagliflozin (Visits 3-4). No comparison group is foreseen for this study.

Read the detailed description

Paediatric heart failure is a relevant healthcare issue, with almost 15'000 yearly hospitalizations just in the USA. Sadly, current heart failure therapy in Paediatrics is still unsatisfactory, with high in-hospital (7-26%), and 5-year mortality (30%-50%).

Among the recent improvements in adult heart failure management, impressive is the discovery that Dapagliflozin and Empagliflozin are able to reduce cardiovascular death or worsening heart failure by 25% on top of optimal medical therapy. Indeed, since 2021, they have been recommended as part of standard heart failure therapy.

In the past, paediatric heart failure trials often failed, mainly because of suboptimal dose or inappropriate formulations and endpoints.

This phase II.a, cross-over, open-label trial is designed to characterize pharmacokinetics (primary outcome), palatability, safety and explore potential efficacy markers (secondary outcomes) of Dapagliflozin and Empagliflozin in 12 heart failure children, so to inform the design and performance of subsequent, state-of-the-art, high-quality efficacy trials.

Participants will first receive Drug A (either Dapagliflozin, n=6, or Empagliflozin, n=6) during 3-5 weeks, followed by the other molecule (Drug B) for 2 weeks. They will have 4 visits, one end-study visit and 11-15 pharmacokinetic samples (depending on their weight). The timing of these samples will be optimized exploiting contemporary modeling and simulation techniques.

Safety evaluation will occur throughout the study, while palatability will be evaluated at Visits 1 (Drug A) and 3 (Dug B), and efficacy markers at Visits 1, 3 and 4.

Pharmacokinetic modeling will characterize primary and secondary pharmacokinetic parameters and allow to define the optimal paediatric dose, informing both current compassionate-care use and the design of future efficacy trials.

Conditions
Heart Failure
Being tested
Dapagliflozin tablet, Empagliflozin Tablets
Keywords
child
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin tabletDrug

    Patients randomized to Group A will start with Dapagliflozin on Visit 1 and take Dapagliflozin once daily up to the day before Visit 3.

    Patients randomized to Group B will start Dapagliflozin once daily on the day of Visit 3, to be continued up to the day preceding Visit 4.

    Dose:

    • participants ≤12 year old: 5mg once daily p.o. (commercially available tablet)
    • participants >12 year old: 10mg once daily p.o. (commercially available tablet)

  • Empagliflozin TabletsDrug

    Patients randomized to Group A will start with Empagliflozin on Visit 1 and take Empagliflozin once daily up to the day before Visit 3.

    Patients randomized to Group B will start Empagliflozin once daily on the day of Visit 3, to be continued up to the day preceding Visit 4.

    Dose: Empagliflozin 10mg once daily p.o. (commercially available tablet)

Study groups in NCT06012266
Study groupRoleWhat they receive
Group A: Dapagliflozin first, Empagliflozin secondActive comparatorPatients randomized to Group A will start with Dapagliflozin on Visit 1 and take Dapagliflozin once daily up to the day before Visit 3. On the day of Visit 3, they will switch to Empagliflozin once daily, to be continued up to the day preceding Visit 4.
Receives: Drug: Dapagliflozin tablet; Drug: Empagliflozin Tablets
Group B: Empagliflozin first, Dapagliflozin secondActive comparatorPatients randomized to Group B will start with Empagliflozin on Visit 1 and take Empagliflozin once daily up to the day before Visit 3. On the day of Visit 3, they will switch to Dapagliflozin once daily, to be continued up to the day preceding Visit 4.
Receives: Drug: Dapagliflozin tablet; Drug: Empagliflozin Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics 1: Dapagliflozin, respectively Empagliflozin half-life

    This will be derived by pharmacokinetic analysis and modeling, basing on Dapagliflozin, respectively Empagliflozin, concentrations at the different time-points (5-6 samples [according to weight] at Visit 1, 1 opportunistic sample at Visits 2 and 3 for Drug A; 5-6 samples [according to weight] at Visit 3 and 1 opportunistic sample at Visit 4 for Drug B; the timing of the samples will be optimized with modeling \& simulation techniques).

    Measured: Visits 1-4 (Visit 1 = day 1, Visit 2 = week 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  2. Pharmacokinetics 2: Dapagliflozin, respectively Empagliflozin Volume of distribution

    This will be derived by pharmacokinetic analysis and modeling, basing on Dapagliflozin, respectively Empagliflozin, concentrations at the different time-points (5-6 samples [according to weight] at Visit 1, 1 opportunistic sample at Visits 2 and 3 for Drug A; 5-6 samples [according to weight] at Visit 3 and 1 opportunistic sample at Visit 4 for Drug B; the timing of the samples will be optimized with modeling \& simulation techniques).

    Measured: Visits 1-4 (Visit 1 = day 1, Visit 2 = week 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  3. Pharmacokinetics 3: Dapagliflozin, respectively Empagliflozin AUC

    This will be derived by pharmacokinetic analysis and modeling, basing on Dapagliflozin, respectively Empagliflozin, concentrations at the different time-points (5-6 samples [according to weight] at Visit 1, 1 opportunistic sample at Visits 2 and 3 for Drug A; 5-6 samples [according to weight] at Visit 3 and 1 opportunistic sample at Visit 4 for Drug B; the timing of the samples will be optimized with modeling \& simulation techniques).

    Measured: Visits 1-4 (Visit 1 = day 1, Visit 2 = week 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

Secondary outcomes (10)

  1. Safety 1 - eGFR

    Creatinine (respectively Cystatin C in DMD participants) will be collected in order to calculate eGFR (bedside Schwartz formula, respectively Filler equation).

    Measured: Visits 1-4 (Visit 1 = day 1, Visit 2 = week 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  2. Safety 2 - Occurrence of hypoglycemia

    Blood glucose will be checked three times at Visit 1 and Visit 3 (baseline, at the time of 2nd PK sampling, which will be individualized but will be at approximately 2-3h post-intake, and before discharge at 8h post-intake), as well as once at Visits 2 and 4 (together with PK sampling). Outcome measure: number of patients experiencing hypoglycemia.

    Measured: Visits 1-4 (Visit 1 = day 1, Visit 2 = week 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  3. Safety 3 - Occurrence of ketoacidosis

    The outcome is presence (or absence) of ketoacidosis. This will be assessed at Visits 1, 2, 3, and 4. Outcome measure: number of patients experiencing ketoacidosis.

    Measured: Visits 1-4 (Visit 1 = day 1, Visit 2 = week 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  4. Ease-of-swallow

    Ease of swallow will be assessed by means of facial hedonic scales, according to our standard procedure, at Visit 1 (Drug A), and Visit 3 (Drug B). (Scale 1 to 4, 1 being the worse and 4 the best score: very difficult - difficult - possible - easy to swallow.)

    Measured: Visit 1, Visit 3 (Visit 1 = day 1, Visit 3 = week 3 to 5 after study start)

  5. Efficacy and efficacy markers (exploratory) 1 - Heart failure severity class

    Symptoms, clinical signs, NYHA (if >8 years of age) / Ross (if <8 years of age) class assignment. NYHA and Ross heart failure classes share the same scale of I (no limitation of physical activity) to IV (symptoms at rest). Analysis will be performed at Visit 1, Visit 3 and Visit 4. Outcome: change between Visit 1 and Visit 4.

    Measured: Visits 1, 3 and 4 (Visit 1 = day 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  6. Efficacy and efficacy markers (exploratory) 2 - NT-proBNP level

    Analysis will be performed at Visits 1, 3 and 4. Outcome: change between Visit 1 and Visit 4.

    Measured: Visits 1, 3 and 4 (Visit 1 = day 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  7. Efficacy and efficacy markers (exploratory) 3 - Echocardiography 1: Left-ventricular end-diastolic diameter (LVEDd)

    LVEDd (mm) will be measured at Visits 1, 3 and 4. Outcome: change between Visit 1 and Visit 4.

    Measured: Visits 1, 3 and 4 (Visit 1 = day 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  8. Efficacy and efficacy markers (exploratory) 4 - Echocardiography 2: Left-ventricular end-systolic diameter (LVESd)

    LVESd (mm) will be measured at Visits 1, 3 and 4. Outcome: change between Visit 1 and Visit 4.

    Measured: Visits 1, 3 and 4 (Visit 1 = day 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  9. Efficacy and efficacy markers (exploratory) 5 - Echocardiography 3: Fractional shortening (FS)

    FS (%) will be measured at Visits 1, 3 and 4. Outcome: change between Visit 1 and Visit 4.

    Measured: Visits 1, 3 and 4 (Visit 1 = day 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

  10. Efficacy and efficacy markers (exploratory) 6 - Echocardiography 4: Left ventricular ejection fraction (LV-EF)

    LV-EF (%) will be measured at Visits 1, 3 and 4. Outcome: change between Visit 1 and Visit 4.

    Measured: Visits 1, 3 and 4 (Visit 1 = day 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2023
  2. Study startAug 2024 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Order of drug intake will be balanced and randomized, with 6 patients starting with Dapagliflozin (Visits 1-2) and subsequently switching to Empagliflozin (Visits 3-4), and 6 patients starting with Empagliflozin (Visits 1-2) and subsequently switching to Dapagliflozin (Visits 3-4).
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06012266
Sponsor's protocol ID
22HL33
Other IDs
2023-000441-16, 2023
Status last verified
Feb 2024
First submitted
4 Aug 2023
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Das BB. Current State of Pediatric Heart Failure. Children (Basel). 2018 Jun 28;5(7):88. doi: 10.3390/children5070088.

    PubMed 29958420

  • Rossano JW, Kim JJ, Decker JA, Price JF, Zafar F, Graves DE, Morales DL, Heinle JS, Bozkurt B, Towbin JA, Denfield SW, Dreyer WJ, Jefferies JL. Prevalence, morbidity, and mortality of heart failure-related hospitalizations in children in the United States: a population-based study. J Card Fail. 2012 Jun;18(6):459-70. doi: 10.1016/j.cardfail.2012.03.001. Epub 2012 Apr 10.

    PubMed 22633303

  • Ahmed H, VanderPluym C. Medical management of pediatric heart failure. Cardiovasc Diagn Ther. 2021 Feb;11(1):323-335. doi: 10.21037/cdt-20-358.

    PubMed 33708503

  • Andrews RE, Fenton MJ, Dominguez T, Burch M; British Congenital Cardiac Association. Heart failure from heart muscle disease in childhood: a 5-10 year follow-up study in the UK and Ireland. ESC Heart Fail. 2016 Jun;3(2):107-114. doi: 10.1002/ehf2.12082. Epub 2016 Jan 24.

    PubMed 27812385

  • Newland DM, Law YM, Albers EL, Friedland-Little JM, Ahmed H, Kemna MS, Hong BJ. Early Clinical Experience with Dapagliflozin in Children with Heart Failure. Pediatr Cardiol. 2023 Jan;44(1):146-152. doi: 10.1007/s00246-022-02983-0. Epub 2022 Aug 10.

    PubMed 35948644

  • Towbin JA, Lowe AM, Colan SD, Sleeper LA, Orav EJ, Clunie S, Messere J, Cox GF, Lurie PR, Hsu D, Canter C, Wilkinson JD, Lipshultz SE. Incidence, causes, and outcomes of dilated cardiomyopathy in children. JAMA. 2006 Oct 18;296(15):1867-76. doi: 10.1001/jama.296.15.1867.

    PubMed 17047217

  • McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

    PubMed 31535829

  • Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.

    PubMed 32865377

  • Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.

    PubMed 35083827

  • Cella M, Knibbe C, Danhof M, Della Pasqua O. What is the right dose for children? Br J Clin Pharmacol. 2010 Oct;70(4):597-603. doi: 10.1111/j.1365-2125.2009.03591.x. No abstract available.

    PubMed 21087295

  • Benjamin DK Jr, Smith PB, Jadhav P, Gobburu JV, Murphy MD, Hasselblad V, Baker-Smith C, Califf RM, Li JS. Pediatric antihypertensive trial failures: analysis of end points and dose range. Hypertension. 2008 Apr;51(4):834-40. doi: 10.1161/HYPERTENSIONAHA.107.108886. Epub 2008 Mar 10.

    PubMed 18332283

  • European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Eur J Health Law. 2008 Jul;15(2):223-50. doi: 10.1163/157180908x333228.

    PubMed 18988606

  • Bellanti F, Della Pasqua O. Modelling and simulation as research tools in paediatric drug development. Eur J Clin Pharmacol. 2011 May;67 Suppl 1(Suppl 1):75-86. doi: 10.1007/s00228-010-0974-3. Epub 2011 Jan 19.

    PubMed 21246352

  • Bellanti F, Di Iorio VL, Danhof M, Della Pasqua O. Sampling Optimization in Pharmacokinetic Bridging Studies: Example of the Use of Deferiprone in Children With beta-Thalassemia. J Clin Pharmacol. 2016 Sep;56(9):1094-103. doi: 10.1002/jcph.708. Epub 2016 Apr 1.

    PubMed 26785826

  • Lava SA, Simonetti GD, Bianchetti AA, Ferrarini A, Bianchetti MG. Prevention of vitamin D insufficiency in Switzerland: a never-ending story. Int J Pharm. 2013 Nov 30;457(1):353-6. doi: 10.1016/j.ijpharm.2013.08.068. No abstract available.

    PubMed 24216246

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin tablet and Empagliflozin Tablets in people with Heart Failure, run by Centre Hospitalier Universitaire Vaudois at 3 sites in 2 countries.

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 26 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Sebastiano A.G. Lava, MD MSc (+41 21 314 3556, webmaster@sebastianolava.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics 1: Dapagliflozin, respectively Empagliflozin half-life (time frame: Visits 1-4 (Visit 1 = day 1, Visit 2 = week 1, Visit 3 = week 3 to 5, Visit 4 = week 4 to 6 after study start)). The study lists 3 primary outcomes in all. 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 NCT06012266, which also lists 18 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 7 Feb 2024.

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