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Undersøgelse for at vurdere effektiviteten og sikkerheden af ​​CDR132L hos patienter med reduceret venstre ventrikulær ejektionsfraktion efter myokardieinfarkt (HF-REVERT)

3. august 2026 opdateret af: Cardior Pharmaceuticals GmbH

Fase 2, multicenter, randomiseret, parallel, 3-arm, placebokontrolleret undersøgelse for at vurdere effektiviteten og sikkerheden af ​​CDR132L hos patienter med reduceret venstre ventrikulær ejektionsfraktion (≤ 45 %) efter myokardieinfarkt

Dette er et fase 2, multicenter, randomiseret, parallelt, 3-armet, placebokontrolleret studie til vurdering af effektivitet og sikkerhed af CDR132L hos patienter med reduceret venstre ventrikulær ejektionsfraktion (LVEF) (≤ 45%) efter myokardieinfarkt (MI). Denne undersøgelse består af en screeningsperiode (skal forekomme mindst 3 dage efter MI-diagnose), en 6-måneders dobbeltblind periode og en 6-måneders forlængelsesperiode med End of Study (EOS) besøg på dag 360/måned 12 .

To doser af CDR132L vil blive testet mod placebo på deres virkninger på patienter, som netop har haft et hjerteanfald ud over standardbehandling. Formålet med undersøgelsen er at vise, at CDR132L er sikkert og effektivt til at forbedre hjertesvigt hos sådanne patienter.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

294

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige
        • Queen Elizabeth University Hospital
      • High Wycombe, Det Forenede Kongerige
        • Wycombe Hospital
      • London, Det Forenede Kongerige
        • Richmond Pharmacology Limited
      • Middlesbrough, Det Forenede Kongerige
        • South Tees Hospital NHS Foundation Trust
  • Grækenland
      • Athens, Grækenland
        • "Alexandra" General Hospital of Athens
      • Athens, Grækenland
        • "Attikon" General University Hospital
      • Pátrai, Grækenland
        • General University Hospital of Patras "Panagia i Voitheia"
  • Holland
      • 's-Hertogenbosch, Holland
        • Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch
      • Deventer, Holland
        • Deventer Ziekenhuis
      • Doetinchem, Holland
        • Slingeland Ziekenhuis
      • Ede, Holland
        • Gelderse Vallei Ziekenhuis
      • Leeuwarden, Holland
        • Medisch Centrum Leeuwarden
      • Lelystad, Holland
        • St. Jansdal Ziekenhuis
      • Rotterdam, Holland
        • Erasmus University Medical Center
      • Rotterdam, Holland
        • Ikazia Ziekenhuis
      • Sneek, Holland
        • D & A Research B.V.
      • Zutphen, Holland
        • Gelre Ziekenhuizen
  • Polen
      • Kielce, Polen
        • Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego
      • Krakow, Polen
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II
      • Kędzierzyn-Koźle, Polen
        • Polsko Amerykanskie Kliniki Serca
      • Libiąż, Polen
        • Gabinet Internistyczno-Kardiologiczny Jacek Nowak
      • Lodz, Polen
        • NZOZ SALUS JZ Peruga
      • Lublin, Polen
        • One wojskowy Szpital Kliniczny w Lublinie
      • Oświęcim, Polen
        • Medicome Sp. z o.o.
      • Przemyśl, Polen
        • Wojewodzki Szpital Im. SW. Ojca Pio W Przemyslu
      • Sopot, Polen
        • NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
      • Torun, Polen
        • Wojewodzki Szpital Zespolony
      • Wałbrzych, Polen
        • Spec.Szpital im.dr Sokolowskiego
      • Wroclaw, Polen
        • Investigational Site
  • Spanien
      • Badalona, Spanien
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spanien
        • Hospital de La Santa Creu i Sant Pau
      • Granada, Spanien
        • Hospital Universitario San Cecilio
      • Madrid, Spanien
        • Hospital Universitario La Paz
      • Murcia, Spanien
        • Hospital Universitario Virgen de la Arrixaca
      • Sabadell, Spanien
        • Hospital Universitario de Sabadell
      • Seville, Spanien
        • Hospital Universitario Virgen Macarena
      • Valencia, Spanien
        • Hospital Clínico Universitario de Valencia
      • Vigo, Spanien
        • Complejo Hospitalario Universitario de Vigo
  • Tjekkiet
      • Prague, Tjekkiet
        • Institut klinicke a experimentalni mediciny
      • Prague, Tjekkiet
        • Vseobecna fakultni nemocnice v Praze
  • Tyskland
      • Ahaus, Tyskland
        • St. Marien-Krankenhaus Ahaus
      • Dresden, Tyskland
        • Herzzentrum Dresden Universitätsklinik
      • Erfurt, Tyskland
        • Helios Klinikum Erfurt
      • Göttingen, Tyskland
        • Universitätsmedizin Göttingen
      • Hanover, Tyskland
        • Medizinische Hochschule Hannover
      • Kiel, Tyskland
        • Universitatsklinikum Schleswig-Holstein
      • Ludwigshafen, Tyskland
        • Klinikum Ludwigshafen
      • Würzburg, Tyskland
        • Universitätsklinikum Würzburg
  • Ungarn
      • Budapest, Ungarn
        • Semmelweis University

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

Aldre berettiget til at studere

30 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Hovedinkluderingskriterier:

  1. Mandlige eller kvindelige patienter i alderen ≥ 30 til ≤ 80 år på datoen for underskrivelse af informeret samtykke, som defineres som begyndelsen af ​​screeningsperioden.
  2. Spontan akut mykardieinfarkt (AMI) (type I) baseret på den universelle MI-definition med randomisering til at ske senest 14 dage efter indekshændelsesdiagnose.
  3. Patient med en LVEF ≤ 45 % målt ved EKHO efter MI-diagnose (STEMI eller NSTEMI).
  4. Patient med tidligere MI-hændelser i historien kan inkluderes.
  5. Patient med kropsvægt ≤ 120 kg.
  6. N-terminal pro B-type natriuretisk peptidniveau ≥ 125 pg/ml og < 8000 pg/ml ved screening.
  7. Patient med STEMI/NSTEMI, som gennemgik perkutan koronar intervention for denne hændelse.

Ekskluderingskriterier:

  1. En kvinde i den fødedygtige alder (WOCBP).
  2. Patient med HF af ikke-iskæmisk oprindelse; fx myokarditis, alkoholisk kardiomyopati.
  3. Patient med New York Heart Association (NYHA) klasse IV ved screening eller randomisering.
  4. Patienten har planlagt hjerteindgreb (angiogram uden angioplastik er acceptabelt) eller enhver anden planlagt operation efter screeningsperioden.
  5. Patienten har alvorlig hjerteklapsygdom.
  6. Patienten har systolisk BP < 90 mmHg eller > 180 mmHg, diastolisk BP < 50 mmHg eller > 110 mmHg og/eller hjertefrekvens < 50 eller > 100 slag/minut ved screening eller randomisering.
  7. Patient med en estimeret glomerulær filtrationshastighed < 30 ml/min/1,73 m2 eller i dialyse.
  8. Patient med leverinsufficiens klassificeret som Child-Pugh B eller C.
  9. Patienten har en sygehistorie med sygdom(er), der påvirker blod-hjerne-barrieren, f.eks. slagtilfælde inden for 6 måneder eller multipel sklerose.
  10. Patienten har en sygehistorie med blødningsforstyrrelser eller har trombocytopeni (blodplader < 100.000/μL).
  11. Patienten har dårligt kontrolleret diabetes som bestemt af investigator.
  12. Patienten har en historie eller tilstedeværelse af en af ​​følgende hjertesygdomme: kendte strukturelle hjerteabnormaliteter ud over HF, familiehistorie med lang QT-syndrom, hjertesynkope eller tilbagevendende, idiopatisk synkope.
  13. Eventuelle klinisk signifikante abnormiteter, efter investigatorens skøn, i rytme, overledning eller morfologi af hvile-EKG, der udgør en yderligere sikkerhedsrisiko for patienterne.
  14. Patient med aktiv "svær akut respiratorisk syndrom coronavirus 2 (SARS-CoV-2)"-infektion bekræftet i henhold til de lokale testretningslinjer ved screening.
  15. Patienter skal ikke tilmeldes undersøgelsen, hvis de modtog forbudt behandling inden for 3 måneder efter screening.

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
Intervention / Behandling
Eksperimentel: CDR132L 5 mg
CDR132L 5 mg/kg legemsvægt intravenøst ​​i enkeltdosis på dag 1, dag 29 og dag 57
Medicin: CDR132L
CDR132L er et syntetisk antisense-oligonukleotid (ASO) og en selektiv hæmmer af microRNA-132-3p (miR-132). miR-132 i kardiomyocytter er en central switch, der påvirker ekspressionen af ​​gener, der er afgørende involveret i maladaptiv hjerteomdannelse, transformation og patologisk hjertevækst (hypertrofi), hvilket bidrager til uønsket hjerteomdannelse og hjertesvigt (HF).1-5 Aberrant ekspression af miR-132 i hjerteceller er kausalt forbundet med hjerteombygning og HF-progression.
Eksperimentel: CDR132L 10 mg
CDR132L 10 mg/kg legemsvægt intravenøst ​​i enkeltdosis på dag 1, dag 29 og dag 57
Medicin: CDR132L
CDR132L er et syntetisk antisense-oligonukleotid (ASO) og en selektiv hæmmer af microRNA-132-3p (miR-132). miR-132 i kardiomyocytter er en central switch, der påvirker ekspressionen af ​​gener, der er afgørende involveret i maladaptiv hjerteomdannelse, transformation og patologisk hjertevækst (hypertrofi), hvilket bidrager til uønsket hjerteomdannelse og hjertesvigt (HF).1-5 Aberrant ekspression af miR-132 i hjerteceller er kausalt forbundet med hjerteombygning og HF-progression.
Placebo komparator: Placebo
Placebo intravenøst ​​i enkeltdosis på dag 1, dag 29 og dag 57
Medicin: Placebo til CDR132L
Placebo til CDR132L

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in LVESVI (Left Ventricular End-systolic Volume Index) at Month 6
Tidsramme: Baseline (Day 1), Month 6
Percent change from baseline in LVESVI at Month 6 is presented. LVESVI is considered one of the standard echocardiography (ECHO) markers for assessing risks in ischemic heart failure (HF). The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to 12 months
Number of TEAEs were presented. TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of study treatment and prior to 30 days after the last administration of study treatment.
Up to 12 months
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Tidsramme: Up to 12 months
Number of TESAEs are presented. TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of study treatment and prior to 30 days after the last administration of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent disability/incapacity, e) is a congenital anomaly/birth defect, f) other situations where medical or scientific judgement should be excercised.
Up to 12 months
Number of Participants With Abnormalities in Clinically Relevant Laboratory Assessments
Tidsramme: At month 6
Number of participants with abnormalities in clinically relevant laboratory assessments up to month 6 is presented. Laboratory investigation included hematology, chemistry, coagulation and urinalysis parameters. Clinical relevance was decided by the investigator.
At month 6
Number of Participants With Clinically Relevant Laboratory Abnormalities in Vital Signs Parameters
Tidsramme: At month 12
Number of participants with clinically relevant laboratory abnormalities in vital signs parameters on month 12 is presented. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical relevance was decided by the investigator.
At month 12
Number of Participants With Clinically Relevant Laboratory Abnormalities in ECG Parameters
Tidsramme: At month 12
Number of participants with clinically relevant laboratory abnormalities in ECG parameters at month 12 is presented. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Pulse Rate, QRS, QT interval. Clinical relevance was decided by the investigator.
At month 12
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 3
Tidsramme: Baseline (Day 1), Month 3
Absolute change from baseline in LVEF at month 3 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D echocardiography (ECHO) was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 3
Absolute Change From Baseline in LVEF at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in LVEF at month 6 is reported. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 6
Absolute Change From Baseline in LVEF at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in LVEF at month 12 is reported. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 12
Relative Change From Baseline in LVEF at Month 3
Tidsramme: Baseline (Day 1), Month 3
Relative change from baseline in LVEF at month 3 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 3
Relative Change From Baseline in LVEF at Month 6
Tidsramme: Baseline (Day 1), Month 6
Relative change from baseline in LVEF at month 6 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 6
Relative Change From Baseline in LVEF at Month 12
Tidsramme: Baseline (Day 1), Month 12
Relative change from baseline in LVEF at month 12 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Baseline (Day 1), Month 12
Absolute Change From Baseline in LVESVI at Month 3
Tidsramme: Baseline (Day 1), Month 3
Absolute change from baseline in LVESVI at month 3 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 3
Absolute Change From Baseline in LVESVI at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in LVESVI at month 6 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 6
Absolute Change From Baseline in LVESVI at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in LVESVI at month 12 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 12
Relative Change From Baseline in LVESVI at Month 3
Tidsramme: Baseline (Day 1), Month 3
Relative change from baseline in LVESVI at month 3 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 3
Relative Change From Baseline in LVESVI at Month 12
Tidsramme: Baseline (Day 1), Month 12
Relative change from baseline in LVESVI at month 12 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Baseline (Day 1), Month 12
Absolute Change From Baseline in Troponin T at Month 3
Tidsramme: Baseline (Day 1), Month 3
Absolute change from baseline in troponin T at month 3 is presented. Troponin T levels were measured by high-sensitivity cardiac troponin (hs-cTn) assays.
Baseline (Day 1), Month 3
Absolute Change From Baseline in Troponin T at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in troponin T at month 6 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 6
Absolute Change From Baseline in Troponin T at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in troponin T at month 12 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 12
Relative Change From Baseline in Troponin T at Month 3
Tidsramme: Baseline (Day 1), Month 3
Relative change from baseline in troponin T at month 3 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 3
Relative Change From Baseline in Troponin T at Month 6
Tidsramme: Baseline (Day 1), Month 6
Relative change from baseline in troponin T at month 6 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 6
Relative Change From Baseline in Troponin T at Month 12
Tidsramme: Baseline (Day 1), Month 12
Relative change from baseline in troponin T at month 12 is presented. Troponin T levels were measured by hs-cTn assays.
Baseline (Day 1), Month 12
Absolute Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Month 1
Tidsramme: Baseline (Day 1), Month 1
Absolute change from baseline in NT-proBNP at month 1 is presented.
Baseline (Day 1), Month 1
Absolute Change From Baseline in NT-proBNP at Month 2
Tidsramme: Baseline (Day 1), Month 2
Absolute change from baseline in NT-proBNP at month 2 is presented.
Baseline (Day 1), Month 2
Absolute Change From Baseline in NT-proBNP at Month 3
Tidsramme: Baseline (Day 1), Month 3
Absolute change from baseline in NT-proBNP at month 3 is presented.
Baseline (Day 1), Month 3
Absolute Change From Baseline in NT-proBNP at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in NT-proBNP at month 6 is presented.
Baseline (Day 1), Month 6
Absolute Change From Baseline in NT-proBNP at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in NT-proBNP at month 12 is presented.
Baseline (Day 1), Month 12
Relative Change From Baseline in NT-proBNP at Month 1
Tidsramme: Baseline (Day 1), Month 1
Relative change from baseline in NT-proBNP at month 1 is presented.
Baseline (Day 1), Month 1
Relative Change From Baseline in NT-proBNP at Month 2
Tidsramme: Baseline (Day 1), Month 2
Relative change from baseline in NT-proBNP at month 2 is presented.
Baseline (Day 1), Month 2
Relative Change From Baseline in NT-proBNP at Month 3
Tidsramme: Baseline (Day 1), Month 3
Relative change from baseline in NT-proBNP at month 3 is presented.
Baseline (Day 1), Month 3
Relative Change From Baseline in NT-proBNP at Month 6
Tidsramme: Baseline (Day 1), Month 6
Relative change from baseline in NT-proBNP at month 6 is presented.
Baseline (Day 1), Month 6
Relative Change From Baseline in NT-proBNP at Month 12
Tidsramme: Baseline (Day 1), Month 12
Relative change from baseline in NT-proBNP at month 12 is presented.
Baseline (Day 1), Month 12
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score (overall summary score) at month 6 is presented. The KCCQ is a 23-item, self-administered ques-tionnaire developed to independently measure the participant's perception of their health status. Scores range from 0 to 100, with 0 as lowest score and 100 as the highest score. Higher scores indi-cate better health status, fewer symptoms, and greater disease-specific health-related quality of life. The calculation is following the KCCQ scoring manual that states: "Overall Summary Score is defined as mean of the following available summary scores: Physical Limitation Score, Total Symptom Score, Quality of Life Score and Social Limitation Score". Because the manual states that the Overall Sum-mary Score should be calculated on available scores, then if physical limitation score is missing, but other sub scores are available the Overall Summary Score will be calculated anyhow based on other sub scores.
Baseline (Day 1), Month 6
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in mean KCCQ score (overall summary score) at month 12 is presented. The KCCQ is a 23-item, self-administered ques-tionnaire developed to independently measure the participant's perception of their health status. Scores range from 0 to 100, with 0 as lowest score and 100 as the highest score. Higher scores indi-cate better health status, fewer symptoms, and greater disease-specific health-related quality of life. The calculation is following the KCCQ scoring manual that states: "Overall Summary Score is defined as mean of the following available summary scores: Physical Limitation Score, Total Symptom Score, Quality of Life Score and Social Limitation Score". Because the manual states that the Overall Summary Score should be calculated on available scores, then if physical limitation score is missing, but other sub scores are available the Overall Summary Score will be calculated anyhow based on other sub scores.
Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in KCCQ subdomain score (symptom burden) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Symptom burden: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in KCCQ subdomain score (symptom burden) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Symptom burden: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in KCCQ subdomain score (physical limitation) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Physical limitation: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in KCCQ subdomain score (physical limitation) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Physical limitation: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 6
Tidsramme: Baseline (Day 1), Month 6
Absolute change from baseline in KCCQ subdomain score (quality of life) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Quality of life: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 12
Tidsramme: Baseline (Day 1), Month 12
Absolute change from baseline in KCCQ subdomain score (quality of life) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Quality of life: scores on a scale of 0 to 100, higher scores means better outcome.
Baseline (Day 1), Month 12

Samarbejdspartnere og efterforskere

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

Sponsor

Cardior Pharmaceuticals GmbH

Efterforskere

  • Ledende efterforsker: Johann Bauersachs, Prof. Dr., Hannover Medical School

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

11. juli 2022

Primær færdiggørelse (Faktiske)

26. september 2024

Studieafslutning (Faktiske)

17. marts 2025

Datoer for studieregistrering

Først indsendt

20. april 2022

Først indsendt, der opfyldte QC-kriterier

27. april 2022

Først opslået (Faktiske)

28. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR132L-P2-01
  • 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
  • 2021-006040-27 (EudraCT nummer)
  • 2023-507569-24-00 (Ctis)

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

produkt fremstillet i og eksporteret fra U.S.A.

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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