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Studie for å vurdere effektivitet og sikkerhet av CDR132L hos pasienter med redusert venstre ventrikkel-ejeksjonsfraksjon etter hjerteinfarkt (HF-REVERT)

3. august 2026 oppdatert av: Cardior Pharmaceuticals GmbH

Fase 2, multisenter, randomisert, parallell, 3-arm, placebokontrollert studie for å vurdere effektiviteten og sikkerheten til CDR132L hos pasienter med redusert venstre ventrikkel-ejeksjonsfraksjon (≤ 45 %) etter hjerteinfarkt

Dette er en fase 2, multisenter, randomisert, parallell, 3-arms, placebokontrollert studie for å vurdere effekt og sikkerhet av CDR132L hos pasienter med redusert venstre ventrikkel ejeksjonsfraksjon (LVEF) (≤ 45 %) etter hjerteinfarkt (MI). Denne studien består av en screeningsperiode (som skal skje minst 3 dager etter MI-diagnose), en 6-måneders dobbeltblind periode og en 6-måneders forlengelsesperiode med slutten av studien (EOS) besøk på dag 360/måned 12 .

To doser av CDR132L vil bli testet mot placebo på effekten på pasienter som nettopp har hatt et hjerteinfarkt i tillegg til standardbehandling. Målet med studien er å vise at CDR132L er trygt og effektivt for å forbedre hjertesvikt hos slike pasienter.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

294

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Hellas
      • Athens, Hellas
        • "Alexandra" General Hospital of Athens
      • Athens, Hellas
        • "Attikon" General University Hospital
      • Pátrai, Hellas
        • General University Hospital of Patras "Panagia i Voitheia"
  • Nederland
      • 's-Hertogenbosch, Nederland
        • Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch
      • Deventer, Nederland
        • Deventer Ziekenhuis
      • Doetinchem, Nederland
        • Slingeland Ziekenhuis
      • Ede, Nederland
        • Gelderse Vallei Ziekenhuis
      • Leeuwarden, Nederland
        • Medisch Centrum Leeuwarden
      • Lelystad, Nederland
        • St. Jansdal Ziekenhuis
      • Rotterdam, Nederland
        • Erasmus University Medical Center
      • Rotterdam, Nederland
        • Ikazia Ziekenhuis
      • Sneek, Nederland
        • D & A Research B.V.
      • Zutphen, Nederland
        • 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
  • Spania
      • Badalona, Spania
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spania
        • Hospital de La Santa Creu i Sant Pau
      • Granada, Spania
        • Hospital Universitario San Cecilio
      • Madrid, Spania
        • Hospital Universitario La Paz
      • Murcia, Spania
        • Hospital Universitario Virgen de la Arrixaca
      • Sabadell, Spania
        • Hospital Universitario de Sabadell
      • Seville, Spania
        • Hospital Universitario Virgen Macarena
      • Valencia, Spania
        • Hospital Clínico Universitario de Valencia
      • Vigo, Spania
        • Complejo Hospitalario Universitario de Vigo
  • Storbritannia
      • Glasgow, Storbritannia
        • Queen Elizabeth University Hospital
      • High Wycombe, Storbritannia
        • Wycombe Hospital
      • London, Storbritannia
        • Richmond Pharmacology Limited
      • Middlesbrough, Storbritannia
        • South Tees Hospital NHS Foundation Trust
  • Tsjekkia
      • Prague, Tsjekkia
        • Institut klinicke a experimentalni mediciny
      • Prague, Tsjekkia
        • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Hovedinkluderingskriterier:

  1. Mannlige eller kvinnelige pasienter, i alderen ≥ 30 til ≤ 80 år på datoen for undertegning av informert samtykke, som er definert som begynnelsen av screeningsperioden.
  2. Spontant akutt mykardieinfarkt (AMI) (type I) basert på den universelle MI-definisjonen med randomisering som skal skje senest 14 dager etter indekshendelsesdiagnose.
  3. Pasient med LVEF ≤ 45 % målt ved EKHO etter MI-diagnose (STEMI eller NSTEMI).
  4. Pasient med tidligere MI-hendelser i historien kan inkluderes.
  5. Pasient med kroppsvekt ≤ 120 kg.
  6. N-terminal pro B-type natriuretisk peptidnivå ≥ 125 pg/ml og < 8000 pg/ml ved screening.
  7. Pasient med STEMI/NSTEMI som gjennomgikk perkutan koronar intervensjon for denne hendelsen.

Ekskluderingskriterier:

  1. En kvinne i fertil alder (WOCBP).
  2. Pasient med HF av ikke-iskemisk opprinnelse; for eksempel myokarditt, alkoholisk kardiomyopati.
  3. Pasient med New York Heart Association (NYHA) klasse IV ved screening eller randomisering.
  4. Pasienten har planlagt hjerteintervensjon (angiogram uten angioplastikk er akseptabelt) eller annen planlagt operasjon etter screeningsperioden.
  5. Pasienten har alvorlig hjerteklaffsykdom.
  6. Pasienten har systolisk blodtrykk < 90 mmHg eller > 180 mmHg, diastolisk blodtrykk < 50 mmHg eller > 110 mmHg, og/eller hjertefrekvens < 50 eller > 100 slag/minutt ved screening eller randomisering.
  7. Pasient med estimert glomerulær filtrasjonshastighet < 30 ml/min/1,73 m2 eller på dialyse.
  8. Pasient med leverinsuffisiens klassifisert som Child-Pugh B eller C.
  9. Pasienten har sykehistorie med sykdom(er) som påvirker blod-hjerne-barrieren, for eksempel hjerneslag innen 6 måneder eller multippel sklerose.
  10. Pasienten har sykehistorie med blødningsforstyrrelser eller har trombocytopeni (blodplater < 100 000/μL).
  11. Pasienten har dårlig kontrollert diabetes som bestemt av etterforskeren.
  12. Pasienten har en historie eller tilstedeværelse av noen av følgende hjertetilstander: kjente strukturelle hjerteabnormaliteter utover HF, familiehistorie med langt QT-syndrom, hjertesynkope eller tilbakevendende, idiopatisk synkope.
  13. Eventuelle klinisk signifikante abnormiteter, etter etterforskerens skjønn, i rytme, ledning eller morfologi av hvile-EKG som utgjør en ekstra sikkerhetsrisiko for pasienter.
  14. Pasient med aktiv "alvorlig akutt respiratorisk syndrom coronavirus 2 (SARS-CoV-2)"-infeksjon bekreftet i henhold til lokale testretningslinjer ved screening.
  15. Pasienter skal ikke delta i studien hvis de mottok forbudt behandling innen 3 måneder etter screening.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CDR132L 5 mg
CDR132L 5 mg/kg kroppsvekt intravenøst ​​i enkeltdose på dag 1, dag 29 og dag 57
Legemiddel: CDR132L
CDR132L er et syntetisk antisense-oligonukleotid (ASO) og en selektiv hemmer av mikroRNA-132-3p (miR-132). miR-132 i kardiomyocytter er en sentral bryter som påvirker ekspresjonen av gener som er avgjørende involvert i maladaptiv hjerteremodellering, transformasjon og patologisk hjertevekst (hypertrofi), og bidrar til uønsket hjerteremodellering og hjertesvikt (HF).1-5 Avvikende uttrykk for miR-132 i hjerteceller er kausalt assosiert med hjerteremodellering og HF-progresjon.
Eksperimentell: CDR132L 10 mg
CDR132L 10 mg/kg kroppsvekt intravenøst ​​i enkeltdose på dag 1, dag 29 og dag 57
Legemiddel: CDR132L
CDR132L er et syntetisk antisense-oligonukleotid (ASO) og en selektiv hemmer av mikroRNA-132-3p (miR-132). miR-132 i kardiomyocytter er en sentral bryter som påvirker ekspresjonen av gener som er avgjørende involvert i maladaptiv hjerteremodellering, transformasjon og patologisk hjertevekst (hypertrofi), og bidrar til uønsket hjerteremodellering og hjertesvikt (HF).1-5 Avvikende uttrykk for miR-132 i hjerteceller er kausalt assosiert med hjerteremodellering og HF-progresjon.
Placebo komparator: Placebo
Placebo intravenøst ​​i enkeltdose på dag 1, dag 29 og dag 57
Legemiddel: Placebo til CDR132L
Placebo til CDR132L

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cardior Pharmaceuticals GmbH

Etterforskere

  • Hovedetterforsker: Johann Bauersachs, Prof. Dr., Hannover Medical School

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. juli 2022

Primær fullføring (Faktiske)

26. september 2024

Studiet fullført (Faktiske)

17. mars 2025

Datoer for studieregistrering

Først innsendt

20. april 2022

Først innsendt som oppfylte QC-kriteriene

27. april 2022

Først lagt ut (Faktiske)

28. april 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere