Efficacy of Verciguat in TR and RV Failure (VERT-HF)
23. juni 2026 oppdatert av: Jung Sun Cho, Daejeon St. Mary's hospital
Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled Trial
The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function. It will also examine the effects of the drug on tricuspid regurgitation (TR) and overall clinical outcomes.
The main questions it aims to answer are:
Does vericiguat improve right ventricular (RV) function and reduce tricuspid regurgitation (TR)? Does vericiguat reduce the risk of major adverse cardiovascular events (MACE), such as heart failure hospitalizations and cardiovascular death? Does vericiguat improve participants' exercise capacity, quality of life, and renal function?
Researchers have previously seen the benefits of vericiguat in the large-scale VICTORIA trial for worsening heart failure, and it is hypothesized that improvements in right heart function play a key role. This study aims to confirm these specific benefits.
Participants will:
Take vericiguat as prescribed during the study period. Undergo echocardiograms at enrollment and at 9 months to assess right heart function.
Complete questionnaires (KCCQ-12) and walking tests (6MWT) to evaluate quality of life and exercise capacity.
Provide blood samples to monitor NTproBNP levels and renal function (creatinine).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Principal Investigator
- Telefonnummer: +82-42-220-9943
- E-post: tworugi@daum.net
Studiesteder
-
-
-
Daejeon, Sør -Korea, 34943
- Daejeon St.Mary's Hospital
-
Ta kontakt med:
- Principle Investigator
- Telefonnummer: +82-42-220-9943
- E-post: tworugi@daum.net
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age more than 19 years old
- right ventricular malfunction confirmed with EKG data or cardiac MRI
- chronic heart failure with LVEF<45%
- Patients Who administrated standard treatment of Heart Failur for over the 4 weeks
- NTproBNP >1000, NTproBNP >1600 with atrial fibrillation or The patient who recently experienced worsening heart failure(Recent hospitalization for worsening heart failure or outpatient administration of intravenous diuretics)
- Tricuspid regurgitation of greater than moderate severity was confirmed by echocardiogram
- Subject who provided voluntary informed consent to participate in the study
- Patients who have not been administered vericiguat within the last 6 months
Exclusion Criteria:
- Patients with a systolic blood pressure (SBP) < 100 mmHg
- Patients currently treated with other sGC stimulators (including vericiguat) or phosphodiesterase-5 (PDE5) inhibitors
- Moderate-to-severe right ventricular (RV) failure requiring surgical intervention
- Patients who are currently pregnant or of childbearing potential
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm with administered with Vericiguat
Subjects assigned to the experimental arm will initiate vericiguat at a daily dose of 2.5 mg, concurrently with their baseline heart failure therapy including standard of care (loop diuretics, MRAs, and SGLT2i).
The dose will be targeted to double every 2 weeks, titrating up to a maximum dose of 10 mg.
|
Participants will start vericiguat at 2.5 mg once daily, and the dose will be gradually uptitration every 2 weeks to a target dose of 10 mg once daily, depending on tolerability.
|
|
Ingen inngripen: Arm with standard of care
This arm is classified as the standard of care control group, where participants receive baseline heart failure therapies including loop diuretics, MRAs, and SGLT2i.
During the study period, if a participant in this arm exhibits no symptomatic improvement or demonstrates clinical worsening despite baseline therapy, the investigator will re-evaluate the doses of the existing standard medications and titrate them up to the maximum recommended doses within a permissible range, or adjust the medication combination to prioritize patient safety.
Additionally, in cases of accompanied fluid overload, further pharmacological interventions, including the adjustment of diuretics, may be administered.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
NTproBNP
Tidsramme: NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.
|
NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.
|
|
|
Echocardiographic RV function parameters
Tidsramme: From enrollment to the end of treatment at baseline and 9 months
|
RVSP, RV volume, TAPSE, RV strain/PAP, TR grade
|
From enrollment to the end of treatment at baseline and 9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite endpoint of Major Adverse Cardiovascular Events (MACE)
Tidsramme: From enrollment to the end of treatment at 9 months
|
Composite endpoint of Major Adverse Cardiovascular Events (MACE), including hospitalization for heart failure (requiring a minimum of 24 hours of hospitalization and intravenous diuretic therapy) and cardiovascular death.
|
From enrollment to the end of treatment at 9 months
|
|
Exercise capacity and quality of life
Tidsramme: From enrollment to the end of treatment at baseline and 9 months
|
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
|
From enrollment to the end of treatment at baseline and 9 months
|
|
6-Minute Walk Test (6MWT distance)
Tidsramme: From enrollment to the end of treatment at baseline and 9 months
|
6-Minute Walk Test (6MWT distance)
|
From enrollment to the end of treatment at baseline and 9 months
|
|
Renal Function
Tidsramme: from enrollment to the end of treatment at baseline, 3 and 9 months.
|
Renal function: Serum creatinine (Cr)
|
from enrollment to the end of treatment at baseline, 3 and 9 months.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
- Metra M, Tomasoni D, Adamo M, Bayes-Genis A, Filippatos G, Abdelhamid M, Adamopoulos S, Anker SD, Antohi L, Bohm M, Braunschweig F, Gal TB, Butler J, Cleland JGF, Cohen-Solal A, Damman K, Gustafsson F, Hill L, Jankowska EA, Lainscak M, Lund LH, McDonagh T, Mebazaa A, Moura B, Mullens W, Piepoli M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Tocchetti CG, Yilmaz MB, Vitale C, Volterrani M, von Haehling S, Chioncel O, Coats AJS, Rosano G. Worsening of chronic heart failure: definition, epidemiology, management and prevention. A clinical consensus statement by the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2023 Jun;25(6):776-791. doi: 10.1002/ejhf.2874. Epub 2023 May 19.
- Hashimoto T, Yoshitake T, Suenaga T, Yamamoto S, Fujino T, Shinohara K, Matsushima S, Ide T, Kinugawa S, Abe K. Effectiveness of Vericiguat on right ventricle to pulmonary artery uncoupling associated with heart failure with reduced ejection fraction. Int J Cardiol. 2024 Nov 15;415:132441. doi: 10.1016/j.ijcard.2024.132441. Epub 2024 Aug 10.
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 (Antatt)
1. juli 2026
Primær fullføring (Antatt)
31. mai 2028
Studiet fullført (Antatt)
31. mai 2028
Datoer for studieregistrering
Først innsendt
8. juni 2026
Først innsendt som oppfylte QC-kriteriene
23. juni 2026
Først lagt ut (Faktiske)
25. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DC26MIDI0013
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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. .