Blood Flow and Vascular Function in Cystic Fibrosis (CF-FLOW)
23 april 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
19
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Georgia
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Augusta, Georgia, Verenigde Staten, 30912
- Augusta University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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)
Andere namen:
Sugar pill designed to mimic the sildenafil treatment
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Experimenteel: 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.
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Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)
Andere namen:
Sugar pill designed to mimic the sildenafil treatment
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Experimenteel: 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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Acute Study: Percentage Flow-Mediated Dilation (FMD)
Tijdsspanne: 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
Tijdsspanne: pre-treatment Baseline and following 4 weeks sub-chronic treatment
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Brachial Artery Diameter during FMD (pre-occlusion or "baseline")
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pre-treatment Baseline and following 4 weeks sub-chronic treatment
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Peak Diameter
Tijdsspanne: pre-treatment Baseline and following 4 weeks sub-chronic treatment
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Peak Brachial Artery Diameter during FMD (post-occlusion)
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pre-treatment Baseline and following 4 weeks sub-chronic treatment
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Absolute Change in Diameter
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
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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)
Tijdsspanne: 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
Tijdsspanne: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
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peak ventilation (L/min) 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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RER Peak
Tijdsspanne: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
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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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ryan Harris, Ph.D., Augusta University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 april 2014
Primaire voltooiing (Werkelijk)
1 juli 2018
Studie voltooiing (Werkelijk)
1 juli 2018
Studieregistratiedata
Eerst ingediend
4 februari 2014
Eerst ingediend dat voldeed aan de QC-criteria
6 februari 2014
Eerst geplaatst (Schatting)
7 februari 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 april 2020
Laatste update ingediend die voldeed aan QC-criteria
23 april 2020
Laatst geverifieerd
1 april 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Pathologische processen
- Ziekten van de luchtwegen
- Longziekten
- Baby, pasgeborene, ziekten
- Genetische ziekten, aangeboren
- Alvleesklier Ziekten
- Fibrose
- Taaislijmziekte
- Moleculaire mechanismen van farmacologische werking
- Vaatverwijdende middelen
- Urologische middelen
- Enzymremmers
- Fosfodiësteraseremmers
- Fosfodiësterase 5-remmers
- Sildenafil Citraat
Andere studie-ID-nummers
- DK100783
- R21DK100783 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .