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This Will be a Randomized Comparison of the Proteomic Effects of Vicadrostat/Empagliflozin Versus Empagliflozin and Versus Empagliflozin/Spironolactone in Heart Failure Patients With Preserved Ejection Fraction (SPECTRA-HFpEF)

29. september 2026 opdateret af: Baim Institute for Clinical Research

A Randomized Comparison of the Proteomic Effects of Vicadrostat/Empagliflozin Versus Empagliflozin and Versus Empagliflozin/Spironolactone in Heart Failure Patients With Preserved Ejection Fraction

The SPECTRA-HFpEF Study is a randomized, double-blind, Phase 2 clinical study designed to evaluate and compare the biological effects of vicadrostat in combination with empagliflozin, empagliflozin alone, and spironolactone in combination with empagliflozin in adults with heart failure and preserved ejection fraction. The study will enroll approximately 200 participants with chronic heart failure, New York Heart Association Class II to IV symptoms, and left ventricular ejection fraction greater than 40%. The primary objective is to determine whether treatment with vicadrostat/empagliflozin produces differential changes in circulating plasma proteins compared with spironolactone/empagliflozin, using a broad proteomic panel measured over the course of treatment. These proteomic changes may help identify biological pathways affected by each treatment strategy, including pathways related to inflammation, myocardial fibrosis and remodeling, kidney function, cardiac stress, and aldosterone-related signaling.

Participants will complete an approximately 26-week study period, including screening, treatment, and follow-up phases. After screening and any required washout of prior sodium-glucose cotransporter 2 inhibitor therapy, participants will receive open-label empagliflozin and will be randomized in a blinded manner to receive vicadrostat or placebo during the first treatment period. During the second treatment period, participants will receive either continued vicadrostat with empagliflozin or spironolactone with empagliflozin. During the third treatment period, vicadrostat or spironolactone will be discontinued while empagliflozin is continued. Blood and urine samples will be collected at specified visits to evaluate changes in proteomic markers, renin-angiotensin-aldosterone system biomarkers, collagen turnover markers, sex hormone markers, kidney function, proteinuria, inflammatory biomarkers, and cardiac stress biomarkers. Echocardiography and patient-reported health status assessments will also be performed to explore potential effects on cardiac structure, function, symptoms, and quality of life.

The study is intended to improve understanding of how aldosterone synthase inhibition with vicadrostat differs from mineralocorticoid receptor antagonism with spironolactone when each is used with empagliflozin in patients with heart failure and preserved ejection fraction. By comparing treatment-related proteomic and biomarker changes across study arms, the study may provide insight into mechanistic differences between these therapeutic approaches and help inform future development of targeted combination therapies for heart failure. Safety and tolerability will be monitored throughout the study through collection of adverse events, serious adverse events, vital signs, electrocardiograms, physical examinations, and clinical laboratory assessments, including kidney function and serum potassium monitoring.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This double-blind, randomized, Phase 2 study is being conducted in adult participants with heart failure (HF) and left ventricular ejection fraction (LVEF) >40% to primarily assess the impact of vicadrostat/empagliflozin (vica/empa) versus placebo/empa and versus spironolactone (spiro)/empa on the proteome.

The study includes 4 discrete study periods. All doses will be given once daily (QD) during the Treatment Periods. Empa will be given open-label.

  • Screening: 4 week duration including a 2-week washout period of SGLT2 inhibitors

  • Treatment Period 1: participants will be given open-label empa 10 mg QD and randomized to vica 10 mg QD versus placebo QD (8 weeks)

  • Treatment Period 2: vica 10 mg QD/empa 10 mg QD versus spiro 25-50 mg QD/empa 10 mg QD (10 weeks)

    • Participants randomized to vica in Treatment Period 1 will continue treatment and remain blinded.
    • Participants randomized to placebo in Treatment Period 1 will be given blinded spiro/empa.

  • Treatment Period 3:

    • Discontinuation of vica or spiro.
    • Continuation of open-label empa in both treatment arms.

The main questions for the analysis include:

  • The relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 1 (baseline) through Study Visit 7 (18 weeks), compared between those treated with vica/empa versus spiro/empa
  • The safety profile of using Incidence of TEAEs and SAEs and change from baseline in clinical laboratory values, vital signs, and ECGs.
  • Additional protenomic analyses between the groups
  • Other blood markers/biomarkers

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
200

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Participant is aged ≥18 years.

  2. Participant provides informed consent to participate in the study in accordance with ICH-GCP and local legislation prior to any study procedures taking place.

  3. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of <1% per year when used consistently and correctly.

  4. Participant has chronic HF diagnosed ≥3 months before enrollment, and in New York Heart Association (NYHA) class II-IV.

  5. Participant has LVEF >40% in the 12 months prior to enrollment.

  6. N-terminal pro-B type natriuretic peptide (NT-proBNP) must be:

    NT-proBNP level (kg/m²) BMI <27 (kg/m²) BMI ≥27 to <35 BMI ≥35 Without AF or AFL Non-Black participants ≥300 pg/mL ≥200 pg/mL ≥125 pg/mL Black Participants ≥240 pg/mL ≥160 pg/mL ≥100 pg/mL With AF or AFL Non-Black participants ≥600 pg/mL ≥400 pg/mL ≥250 pg/mL Black Participants ≥480 pg/mL ≥320 pg/mL ≥200 pg/mL Abbreviations: AF: atrial fibrillation; AFL: atrial flutter. Note: Race is self-reported.

  7. Participants must have ≥1 of the following:

    1. Currently treated with diuretic therapy (e.g. loop diuretics or thiazides) and on a stable dose for ≥1 week prior to enrollment.

    2. Currently treated with an SGLT2 inhibitor and on a stable dose for at ≥1 week prior to enrollment; those receiving an SGLT2 inhibitor for treatment of diabetes mellitus will be monitored for need of extra glucose lowering treatment by the study investigator in conjunction with the local physician during the washout period per usual care.

    3. Documented hospitalization for HF within 6 months prior to enrollment.

    4. Elevated cardiac filling pressures (e.g. pulmonary capillary wedge pressure ≥15 mm at rest or ≥25 mm with exercise) within 6 months prior to enrollment.

    5. Markedly elevated NT-proBNP

      • In participants without AF/AFL: ≥900 pg/mL
      • In participants with AF/AFL: ≥1800 pg/mL

    6. UACR ≥30 mg/g.

    7. At least 2 echocardiographic cardiac structural changes from the following:

      • Left ventricular hypertrophy
      • E/e' ≥9
      • Left atrial volume index >33 mL/m2

Exclusion Criteria:

  1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to enrollment and no intention to initiate MRA during the study.

  2. Treatment with amiloride, direct renin inhibitor (e.g. aliskiren), or the combination of ACEi plus ARB.

  3. Treatment with any other ASi.

  4. Major contraindication to SGLT2 inhibition, including history of Type 1 diabetes or previous ketoacidosis.

  5. eGFR < 20 mL/min/1.73m2 at screening.

  6. Serum potassium >5.2 mmol/L at screening.

  7. Myocardial infarction, cerebrovascular accident, transient ischemic attack, stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery or any other major surgery (per investigator judgement) within 90 days prior to enrollment, or scheduled for major elective surgery (e.g. hip replacement, CABG surgery).

  8. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device.

  9. Known cardiomyopathy due to infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy, or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to enrollment.

  10. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding enrollment.

  11. Known severe valvular heart disease (obstructive or regurgitant), per investigator judgment, or valvular heart disease scheduled for surgical or invasive procedures at enrollment, or anticipated invasive treatment during the study.

  12. Active or prior cancer of any kind except for non-melanoma skin cancers.

  13. Psychiatric illness, cognitive impairment, behavioral issues, or social situation that in the opinion of the investigator will compromise the participant's ability to comply with study procedures

  14. Participant is pregnant or lactating or plans to become pregnant during the study or up to 2 weeks after the study.

  15. Patient has a known hypersensitivity to any components of the IMPs or any of their excipients that, in the opinion of the investigator, suggests a high risk for a severe hypersensitivity reaction while on treatment.

  16. Any other condition not specified above that in the opinion of the investigator would confound the interpretation of data from the study

    -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: empa plus vica

Participants randomized to this arm will receive Vica 10 mg and empa 10 mg (in treatment periods 1 and 2) with empa 10 mg (treatment period 3)
Medicin: empa plus vica

Participants will be randomized to to this arm will receive empa (open-label)/vica (blinded). In treatment period 1 those randomized to empa/vica will be administered one tablet of empa 10 mg QD and one tablet of vica 10 mg QD for 8 weeks. In treatment period 2 for those randomized to empa/vica will continue to take empa 10 mg QD and vica 10 mg QD plus a placebo-matching spiro for 10 weeks. In treatment period 3, this group will receive open-label empa 10 mg QD for 4 weeks.
Aktiv komparator: empa plus spironolactone

Participants randomized to this arm will receive empa 10 mg QD and vica matching placebo tablet in treatment period 1; empa 10 mg QD plus spironolactone 25 mg titrating to 50 mg QD in treatment period 2 and empa 10 mg in treatment period 3.
Medicin: Comparator: empa 10 plus spironolactone

For those randomized to empa (open-label) spiro (blinded), in treatment period 1 they will be administered one tablet of empa 10 mg QD and vica matching placebo for 8 weeks. In treatment period 2 for those randomized to empa/spiro, they will take empa 10 mg QD, spiro 25 mg titrating to 50 mg QD plus a vica matching placebo tablet for 10 weeks. In treatment period 3, this group will receive open-label empa 10 mg QD for 4 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in the proteomic regulation following Treatment Period 2
Tidsramme: 18 weeks

To evaluate the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 1 (baseline) through Study Visit 7 (18 weeks), compared between those treated with vica/empa versus spiro/empa.
18 weeks

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in the proteomic regulation following Treatment Period 1.
Tidsramme: 8 weeks

To evaluate the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 1 (baseline) through Study Visit 4 (8 weeks), compared between those treated with vica/empa versus empa will be evaluated.
8 weeks
Differences in the proteomic regulation following Treatment Period 2
Tidsramme: 10 Weeks (8 weeks through 18 weeks)

To evaluate the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Visit 4 (8 weeks) through Study 7 (18 weeks), compared between those treated with vica/empa versus empa.
10 Weeks (8 weeks through 18 weeks)
Differences in proteomic regulation following Treatment Period 3.
Tidsramme: 4 weeks

To compare the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 7 (18 weeks) through Study Visit 8 (22 weeks), compared between those treated with vica/empa in Treatment Periods 1 and 3 versus empa alone in Treatment Period 3.
4 weeks
Differences in renin, aldosterone and aldosterone precursors across each Treatment Period.
Tidsramme: 22 weeks

To evaluate mean within- participant change in plasma renin activity/concentration, serum aldosterone, and 11-deoxycorticosterone from the beginning and end of each Treatment Period, compared across treatment arms.
22 weeks
Differences in markers of collagen synthesis, degradation and cross-linking across each Treatment Period.
Tidsramme: 22 weeks

To evaluate mean within- participant change in plasma PICP, CITP, MMP1, PIIINP, and Pro-C6 from the beginning and end of each Treatment Period, compared across treatment arms.
22 weeks
Differences in plasma progesterone across each Treatment Period.
Tidsramme: 22 weeks

To evaluate mean within-participant change in plasma progesterone and from the beginning and end of each Treatment Period, compared across treatment arms. This is measured in ng/mL
22 weeks
Differences in measures of kidney function and proteinuria across each Treatment Period.
Tidsramme: 22 weeks

To evaluate mean within-participant change in eGFR and UACR from the beginning and end of each Treatment Period, compared across treatment arms
22 weeks
Differences in inflammation across each Treatment Period.
Tidsramme: 22 weeks

To evaluate mean within- participant change in plasma NT-proBNP and hs-cTnT from the beginning and end of each Treatment Period, compared across treatment arms.
22 weeks
Differences in plasma testosterone across each Treatment Period
Tidsramme: 22 weeks

To evaluate mean within-participant change in plasma testosterone from the beginning and end of each Treatment Period, compared across treatment arms. This will be measured in ng/mL
22 weeks

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in safety and tolerability between treatment groups (vica/empa; placebo/empa; and spiro/empa)
Tidsramme: 22 weeks

To evaluate Incidence of TEAEs and SAEs
22 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1
Tidsramme: 8 weeks

To evaluate change from baseline in clinical laboratory values (serum potassium) with the unit of measure mEq/L
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Tidsramme: 8 weeks

To evaluate change from baseline in clinical laboratory values (serum creatinine) measured in mg/dL
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Tidsramme: 8 weeks

To evaluate change from baseline in blood pressure measured in mm/Hg
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Tidsramme: 8 weeks

To evaluate change from baseline in heart rate measured in bpm units
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Tidsramme: 8 weeks

To evaluate change from baseline in QT (measured via 12-lead ECG) measured in milliseconds (ms)
8 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Tidsramme: 18 weeks

To evaluate change from beginning of Treatment Period 1 until the end of Treatment Period 2 in clinical laboratory values (serum creatinine) measured in mg/dL
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Tidsramme: 18 weeks

To evaluate change from beginning of Treatment Period 1 until the end of Treatment Period 2 in clinical laboratory values (serum potassium) measured in mEq/L
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Tidsramme: 18 weeks

To evaluate the change from the beginning of Treatment Period 1 until the end of Treatment Period 2 in blood pressure measured in mm/Hg
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Tidsramme: 18 weeks

To evaluate the change from beginning of Treatment Period 1 until the end of Treatment Period 2 in heart rate measured in bpm
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Tidsramme: 18 weeks

To evaluate the change from Treatment Period 1 until the end of Treatment Period 2 in QT measured on 12-lead ECG measured in milliseconds (ms)
18 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Tidsramme: 4 weeks

To evaluate the difference in clinical laboratory values (serum creatinine) measured in md/dL between study arms across Treatment Period 3.
4 weeks
Differences in Safety and Tolerability between study arms across Treatment Period 3.
Tidsramme: 4 weeks

To evaluate the difference in clinical laboratory values (serum potassium) measured in mEq/L between study arms across Treatment Period 3.
4 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Tidsramme: 4 weeks

To evaluate the difference in blood pressure measured in mmg/Hg between study arms across Treatment Period 3.
4 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Tidsramme: 4 weeks

To evaluate the difference in heart rate measured in bpm between study arms across Treatment Period 3.
4 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Tidsramme: 4 weeks

To evaluate the difference in QT by 12-lead ECG measured in milliseconds (ms) between study arms across Treatment Period 3.
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Baim Institute for Clinical Research

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: James L Januzzi, MD, Baim Institute for Clinical Research

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. marts 2027

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. maj 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. september 2028

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
22. september 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
29. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
5. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
29. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • BICR 2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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