- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01847716
Transforming Growth Factor Beta Signalling in the Development of Muscle Weakness in Pulmonary Arterial Hypertension
24. september 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
33
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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London, Det Forenede Kongerige, SW36NP
- Royal Brompton Hospital
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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
14 år til 61 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Andet
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
30 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
30 months
|
|
Change in fibre type in muscle biopsy
Tidsramme: 30 months
|
30 months
|
|
|
GDF-15 levels in biopsy specimens
Tidsramme: 30 months
|
30 months
|
|
|
Correlation of plasma Growth and differentiation factor 15 levels with brain natriuretic protein levels
Tidsramme: 30 months
|
30 months
|
|
|
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
|
Quality of life will be measured by St. George's respiratory questionnaire
|
30 months
|
|
Correlation of plasma Growth and differentiation factor 15 levels with exercise tolerance
Tidsramme: 30 months
|
Exercise tolerance will be measured by six minute walk test
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30 months
|
|
Correlation of plasma Growth and differentiation factor levels 15 with physical activity levels
Tidsramme: 30 months
|
Physical activity will be measured by Sensewear armband
|
30 months
|
|
Correlation of plasma Growth and differentiation factor levels 15 with echocardiographic measures of severity of pulmonary hypertension
Tidsramme: 30 months
|
30 months
|
|
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Correlation of GDF-15 levels in biopsy specimens with muscle wasting and weakness
Tidsramme: 30 months
|
Wasting will be measured by quadriceps cross sectional area and weakness will be defined by quadriceps maximal volitional capacity
|
30 months
|
|
Determine the contribution of atrophy and autophagy to muscle wasting in PAH
Tidsramme: 30 months
|
Muscle biopsy specimens will be evaluated using microscopy and real time polymerase chain reaction
|
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
|
Phosphorylation of SMAD and non-SMAD signalling will be determined by western blot
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30 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Stephen J Wort, MBBS, Imperial College / Royal Brompton Hospital
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.
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
1. oktober 2013
Primær færdiggørelse (Faktiske)
1. august 2016
Studieafslutning (Faktiske)
1. august 2016
Datoer for studieregistrering
Først indsendt
19. april 2013
Først indsendt, der opfyldte QC-kriterier
2. maj 2013
Først opslået (Skøn)
7. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2018
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Lungesygdomme
- Neurologiske manifestationer
- Muskuloskeletale sygdomme
- Muskelsygdomme
- Neuromuskulære manifestationer
- Hypertension, lunge
- Forhøjet blodtryk
- Muskelsvaghed
- Pulmonal arteriel hypertension
- Familiær primær pulmonal hypertension
- Parese
- Asteni
Andre undersøgelses-id-numre
- 13IC0457
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
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