Blood Flow and Vascular Function in Cystic Fibrosis (CF-FLOW)
23. april 2020 oppdatert av: Ryan Harris, Augusta University
Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis
Cystic fibrosis (CF) has many health consequences.
A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections.
However, the physiological mechanisms for this reduced exercise capacity are unknown.
The investigators laboratory recently published the first evidence of systemic vascular dysfunction in patients with CF.
Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF.
This study will look at how 1) blood flow and 2) artery function contribute to exercise capacity in CF.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The most disturbing aspect of Cystic Fibrosis (CF) is the associated premature death.
Low exercise capacity predicts death in patients with CF and is also associated with a steeper decline in lung function and more lung infections.
A critical barrier to improving exercise tolerance in patients with CF is the investigators lack of knowledge regarding the different physiological mechanisms which contribute to their lower exercise capacity.
We have compelling data to indicate that the blood vessels may contribute to the low exercise capacity in CF.
The impact of this proof of concept investigation will test Phosphodiesterase Type 5 inhibitors (PDE5) inhibitors as a potential therapy in CF and will explore blood flow and endothelial function as potential mechanisms which contribute to exercise intolerance in CF.
Improvements in exercise capacity will not only contribute to a better quality of live for patients with CF, it will also increase longevity in these patients.
Studietype
Intervensjonell
Registrering (Faktiske)
19
Fase
- Fase 2
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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Georgia
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Augusta, Georgia, Forente stater, 30912
- Augusta University
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria.
- Diagnosis of CF and healthy controls
- Men and women (greater than 18 yrs. old)
- Resting oxygen saturation (room air) greater than 90%
- Forced expiratory volume (FEV1) percent predicted greater than 30%
- Patients with or without CF related diabetes
- Traditional CF-treatment medications
- Ability to perform reliable/reproducible pulmonary function tests (PFT)
- Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status)
Exclusion Criteria.
- Children less than 17 years old
- Body mass less than 20 kg
- A diagnosis of pulmonary arterial hypertension (PAH)
- FEV1 less than 30% of predicted
- Resting oxygen saturation (SpO2) less than 90%
- Self-reported to be a smoker
- Current use of any vaso-active medications
- History of migraine headaches
- Pregnant or nursing at the time of the investigation
- A clinical diagnosis of cardiovascular disease, hypertension, or CF related diabetes
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: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Acute Study: Sildenafil first, then Placebo
In randomized order, on two separate days, endothelial function and exercise capacity will be determined 1 hour following a single dose of sildenafil (50 mg) or placebo.
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Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)
Andre navn:
Sugar pill designed to mimic the sildenafil treatment
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Eksperimentell: Acute Study: Placebo first, then Sildenafil
In randomized order, on two separate days, endothelial function and exercise capacity will be determined 1 hour following a single dose of sildenafil (50 mg) or placebo.
|
Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)
Andre navn:
Sugar pill designed to mimic the sildenafil treatment
|
|
Eksperimentell: Sub-Chronic Study Sildenafil
Following the acute study, patients will be instructed to take 20 mg of sildenafil, three times a day, for 4 weeks.
Endothelial function will be determined within 48 hours following the last dose.
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Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acute Study: Percentage Flow-Mediated Dilation (FMD)
Tidsramme: pre-treatment Baseline and 1 hour post-treatment
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FMD determined one hour after ingestion of 50 mg Sildenafil or placebo
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pre-treatment Baseline and 1 hour post-treatment
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Baseline Diameter
Tidsramme: pre-treatment Baseline and following 4 weeks sub-chronic treatment
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Brachial Artery Diameter during FMD (pre-occlusion or "baseline")
|
pre-treatment Baseline and following 4 weeks sub-chronic treatment
|
|
Peak Diameter
Tidsramme: pre-treatment Baseline and following 4 weeks sub-chronic treatment
|
Peak Brachial Artery Diameter during FMD (post-occlusion)
|
pre-treatment Baseline and following 4 weeks sub-chronic treatment
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Absolute Change in Diameter
Tidsramme: pre-treatment Baseline and following 4 weeks sub-chronic treatment
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Absolute change in brachial artery diameter taken from the FMD assessment
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pre-treatment Baseline and following 4 weeks sub-chronic treatment
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FEV1 (% Predicted)
Tidsramme: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
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Forced Expiratory Volume in the first second expressed as a percent predicted.
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pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
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VO2 Peak (Absolute)
Tidsramme: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
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absolute (L/min) peak oxygen consumption during maximal exercise test
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pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
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VO2 Peak (Relative)
Tidsramme: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
relative (mL/kg/min) peak oxygen consumption during maximal exercise test
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pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
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VO2 Peak (Percent Predicted)
Tidsramme: pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment
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Maximal Oxygen consumption expressed as percent predicted taken from maximal exercise test.
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pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment
|
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VE Peak
Tidsramme: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
peak ventilation (L/min) during maximal exercise test
|
pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
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RER Peak
Tidsramme: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
peak respiratory exchange ratio during maximal exercise test
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pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ryan Harris, Ph.D., Augusta University
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.
Hjelpsomme linker
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)
1. april 2014
Primær fullføring (Faktiske)
1. juli 2018
Studiet fullført (Faktiske)
1. juli 2018
Datoer for studieregistrering
Først innsendt
4. februar 2014
Først innsendt som oppfylte QC-kriteriene
6. februar 2014
Først lagt ut (Anslag)
7. februar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. april 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2020
Sist bekreftet
1. april 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Sykdommer i luftveiene
- Lungesykdommer
- Spedbarn, nyfødte, sykdommer
- Genetiske sykdommer, medfødte
- Pankreassykdommer
- Fibrose
- Cystisk fibrose
- Molekylære mekanismer for farmakologisk virkning
- Vasodilaterende midler
- Urologiske midler
- Enzymhemmere
- Fosfodiesterasehemmere
- Fosfodiesterase 5-hemmere
- Sildenafil Citrate
Andre studie-ID-numre
- DK100783
- R21DK100783 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
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. .