Blood Flow and Vascular Function in Cystic Fibrosis (CF-FLOW)
23 april 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Georgia
-
Augusta, Georgia, Förenta staterna, 30912
- Augusta University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)
Andra namn:
Sugar pill designed to mimic the sildenafil treatment
|
|
Experimentell: 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)
Andra namn:
Sugar pill designed to mimic the sildenafil treatment
|
|
Experimentell: 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.
|
Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acute Study: Percentage Flow-Mediated Dilation (FMD)
Tidsram: pre-treatment Baseline and 1 hour post-treatment
|
FMD determined one hour after ingestion of 50 mg Sildenafil or placebo
|
pre-treatment Baseline and 1 hour post-treatment
|
|
Baseline Diameter
Tidsram: pre-treatment Baseline and following 4 weeks sub-chronic treatment
|
Brachial Artery Diameter during FMD (pre-occlusion or "baseline")
|
pre-treatment Baseline and following 4 weeks sub-chronic treatment
|
|
Peak Diameter
Tidsram: 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
|
|
Absolute Change in Diameter
Tidsram: pre-treatment Baseline and following 4 weeks sub-chronic treatment
|
Absolute change in brachial artery diameter taken from the FMD assessment
|
pre-treatment Baseline and following 4 weeks sub-chronic treatment
|
|
FEV1 (% Predicted)
Tidsram: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
Forced Expiratory Volume in the first second expressed as a percent predicted.
|
pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
|
VO2 Peak (Absolute)
Tidsram: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
absolute (L/min) peak oxygen consumption during maximal exercise test
|
pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
|
VO2 Peak (Relative)
Tidsram: 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
|
pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
|
VO2 Peak (Percent Predicted)
Tidsram: pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment
|
Maximal Oxygen consumption expressed as percent predicted taken from maximal exercise test.
|
pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment
|
|
VE Peak
Tidsram: 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
|
|
RER Peak
Tidsram: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
peak respiratory exchange ratio during maximal exercise test
|
pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ryan Harris, Ph.D., Augusta University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2014
Primärt slutförande (Faktisk)
1 juli 2018
Avslutad studie (Faktisk)
1 juli 2018
Studieregistreringsdatum
Först inskickad
4 februari 2014
Först inskickad som uppfyllde QC-kriterierna
6 februari 2014
Första postat (Uppskatta)
7 februari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 april 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 april 2020
Senast verifierad
1 april 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Luftvägssjukdomar
- Lungsjukdomar
- Spädbarn, nyfödda, sjukdomar
- Genetiska sjukdomar, medfödda
- Bukspottkörtelsjukdomar
- Fibros
- Cystisk fibros
- Molekylära mekanismer för farmakologisk verkan
- Vasodilaterande medel
- Urologiska medel
- Enzyminhibitorer
- Fosfodiesterashämmare
- Fosfodiesteras 5-hämmare
- Sildenafil Citrate
Andra studie-ID-nummer
- DK100783
- R21DK100783 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .