- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01847716
Transforming Growth Factor Beta Signalling in the Development of Muscle Weakness in Pulmonary Arterial Hypertension
24. september 2018 oppdatert av: Imperial College London
Pulmonary arterial hypertension (PAH) is a disease that causes raised blood pressure in blood vessels that pick up oxygen from the lungs.
It has a life expectancy similar to some cancers.
There is treatment available but there is no cure.
We now know that PAH is associated with weakness in the muscles in the legs, which contributes to the symptoms patients' experience.
Researchers believe that certain proteins found in high levels in the blood of patients with other chronic diseases can affect muscle function and growth.
One of these proteins is called growth differentiating factor (GDF) 8, high levels of which are associated with muscle weakness in chronic obstructive pulmonary disease(COPD) and heart failure (HF).
Interestingly there are drugs available which block the actions of GDF-8 on muscle cells which has been shown in animals to result in increased muscle size.
A related protein called GDF-15 is found in elevated levels in patients PAH, and is linked to prognosis.
Our preliminary data suggests that GDF-15 can also directly influence muscle size in a number of situations.
We aim to investigate the role of GDF-15 and related molecules in the development of muscle weakness in patients with PAH.
We will do this by measuring certain markers of muscle weakness and taking blood and muscle samples in patients and controls.
We will then compare the levels of GDF-15 in these tissues in those with and without muscle wasting.
We hope this work will lead to a greater understanding of the role of GDF-15 in the development of muscle weakness in patients with PAH.
GDF-15 levels may be important in allowing us to define which patients have muscle weakness.
In the future we aim to perform a clinical trial of drugs which block the actions of GDF-15.
Studieoversikt
Status
Avsluttet
Studietype
Observasjonsmessig
Registrering (Faktiske)
33
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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London, Storbritannia, SW36NP
- Royal Brompton Hospital
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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
14 år til 61 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Clinics at Royal Brompton and Hammersmith hospital
Beskrivelse
Inclusion Criteria:
- Patients with pulmonary arterial hypertension with New York Heart Association stage II - III disease will be eligible for recruitment in the patient portion of the trial. Interested healthy age matched volunteers will also be recruited.
Exclusion Criteria:
- Patients and volunteers will be excluded if they have significant co-morbidities including other cardiorespiratory disease, metabolic abnormalities including diabetes or thyroid disorders. They will be excluded if they cannot safely exercise and perform a six minute walk test or if they are wheelchair bound.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Annen
Kohorter og intervensjoner
Gruppe / Kohort |
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PH with wasting
This group of patients with idiopathic pulmonary arterial hypertension exhibit quadriceps wasting
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PH no wasting
This groups of patients with idiopathic pulmonary arterial hypertension exhibit no evidence of muscle wasting
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Controls
This group of volunteers does not have pulmonary arterial hypertension and would not be expected to have muscle wasting
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Plasma growth and differentiation factor 15 levels in participants with and without muscle wasting
Tidsramme: 30 months
|
Muscle wasting will be defined by quadriceps cross sectional area measured by ultrasound
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30 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation of plasma Growth and differentiation factor 15 levels with muscle strength
Tidsramme: 30 months
|
Muscle strength will be measured by quadriceps maximal volitional capacity percent predicted
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30 months
|
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Change in fibre type in muscle biopsy
Tidsramme: 30 months
|
30 months
|
|
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GDF-15 levels in biopsy specimens
Tidsramme: 30 months
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30 months
|
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Correlation of plasma Growth and differentiation factor 15 levels with brain natriuretic protein levels
Tidsramme: 30 months
|
30 months
|
|
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Correlation of plasma Growth and differentiation factor 15 levels with fat free mass index
Tidsramme: 30 months
|
Fat free mass index will be measured by bioelectrical impedence
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30 months
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Correlation of plasma Growth and differentiation factor 15 levels with quality of life
Tidsramme: 30 months
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Quality of life will be measured by St. George's respiratory questionnaire
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30 months
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Correlation of plasma Growth and differentiation factor 15 levels with exercise tolerance
Tidsramme: 30 months
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Exercise tolerance will be measured by six minute walk test
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30 months
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Correlation of plasma Growth and differentiation factor levels 15 with physical activity levels
Tidsramme: 30 months
|
Physical activity will be measured by Sensewear armband
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30 months
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Correlation of plasma Growth and differentiation factor levels 15 with echocardiographic measures of severity of pulmonary hypertension
Tidsramme: 30 months
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30 months
|
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Correlation of GDF-15 levels in biopsy specimens with muscle wasting and weakness
Tidsramme: 30 months
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Wasting will be measured by quadriceps cross sectional area and weakness will be defined by quadriceps maximal volitional capacity
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30 months
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Determine the contribution of atrophy and autophagy to muscle wasting in PAH
Tidsramme: 30 months
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Muscle biopsy specimens will be evaluated using microscopy and real time polymerase chain reaction
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30 months
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Determine the contribution of SMAD and non-SMAD signalling pathways to the development of muscle weakness and wasting in PAH
Tidsramme: 30 months
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Phosphorylation of SMAD and non-SMAD signalling will be determined by western blot
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30 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Stephen J Wort, MBBS, Imperial College / Royal Brompton Hospital
Publikasjoner og nyttige lenker
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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
1. oktober 2013
Primær fullføring (Faktiske)
1. august 2016
Studiet fullført (Faktiske)
1. august 2016
Datoer for studieregistrering
Først innsendt
19. april 2013
Først innsendt som oppfylte QC-kriteriene
2. mai 2013
Først lagt ut (Anslag)
7. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. september 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. september 2018
Sist bekreftet
1. september 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Lungesykdommer
- Nevrologiske manifestasjoner
- Muskel- og skjelettsykdommer
- Muskelsykdommer
- Nevromuskulære manifestasjoner
- Hypertensjon, lunge
- Hypertensjon
- Muskel svakhet
- Pulmonal arteriell hypertensjon
- Familiær primær pulmonal hypertensjon
- Parese
- Asteni
Andre studie-ID-numre
- 13IC0457
Plan for individuelle deltakerdata (IPD)
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Ubestemt
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