- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04732039
Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices (Act-VAD)
Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
In patients with terminal HF the gold standard for treatment is heart transplantation, though the Worldwide shortage of donor organs has led to increased use of implantable mechanical circulatory support devices. The treatment with implantable pumps in the form of a Continuous Flow Left Ventricular Assist Device (CF-LVAD, or simply LVAD) is extremely effective for a selected patient groups leading to significant improvement in survival and quality of life.
The device is a battery-powered flow pump that carries the blood from the left ventricle to the main artery, via a cannula, and thus relieves the failing left ventricle with up to 10 liters of blood per minute. An LVAD can be used both as lifelong support therapy (Destination Therapy, DT) or until transplantation can take place (Bridge therapy).
As patients today live for more than 10 years with the device as DT, the focus has shifted from mere survival to quality of life and physical ability.
In recent years, our research group showed that the pump speed and the patient's baseline heart rhythm (sinus rhythm vs atrial fibrillation) and reduced ability to regulate the intrinsic rhythm after implantation (chronotropic incompetence) are significant contributors to the reduced exercise capacity seen in this patient group.
Until now, studies have elucidated the work capacity of this patient group using a 6-minute walk test or bicycle test - none of these reflect how well the patient actually functions in his everyday life.
In this study, we will describe oxygen uptake related to specific daily activities (ADL-VO2) and compare these with the well-known maximum work capacity (percentage of expected oxygen uptake / pVO2) in this patient group.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kiran K Mirza, MD
- Telefonnummer: +4535451442
- E-post: KMIR0003@regionh.dk
Studer Kontakt Backup
- Navn: Finn Gustafsson, MD, PhD, DMSci
- Telefonnummer: 004535459743
- E-post: finn.gustafsson@regionh.dk
Studiesteder
-
-
DK
-
Copenhagen, DK, Danmark, 2100
- Rekruttering
- Rigshospitalet
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
LVADs:
Inclusion Criteria:
- Implanted durable left ventricular assist device
- Age>18yrs
- Signed informed consent
Exclusion Criteria:
- No consent
- Not able to complete VO2 test (physicians decision)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: LVAD recipients
Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients
|
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
|
|
Eksperimentell: Healthy controls
Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls.
|
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
VO2
Tidsramme: Stable LVAD recipients on average 2 years after the implantation
|
Oxygen uptake
|
Stable LVAD recipients on average 2 years after the implantation
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Finn Gustafsson, MD,PhD,DMSci, Rigshospitalet, Denmark
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- H-20049568
Legemiddel- og utstyrsinformasjon, studiedokumenter
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