The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation
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|ClinicalTrials.gov Identifier: NCT03077763|
Recruitment Status : Unknown
Verified March 2017 by University of East Anglia.
Recruitment status was: Recruiting
First Posted : March 13, 2017
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Sodium Nitrite||Phase 1|
This is a healthy volunteer study.
Following entry into this cross-over trial, participants will be randomized to undergo experiments under either normoxic followed by hypoxic conditions, or hypoxic followed by normoxic conditions.
Subjects will donate whole blood as an autologous unit at a preselected NHSBT donation site. The unit will transported back to the NNUH blood bank after a minimum of 30 days (maximum 35 days) after donation.
Volunteers will be tested for baseline bloods. Volunteers will be randomised to normoxia or hypoxia. The will then undergo a nitrite infusion, followed by an autologous whole blood transfusion and a second nitrite infusion (which will co-infuse at the end of the transfusion). During the protocol, the participants will undergo repeated FBFR measurements using strain-gauge plethysmography.
After a minimum of 12 weeks rest period after their initial donation, participants will cross-over to the opposite oxygen condition (as per initial randomization) and the above protocol will be repeated. All interventions will be performed by fully trained and competent medical staff.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Free Haemoglobin NO-blockade on Nitrite Forearm Vessel Dilatation Under Normoxia and Hypoxia in Healthy Volunteers|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Active Comparator: Normoxia and Nitrite (3umol/min-1)
Sodium nitrite stock solution: 100umol/10ml, prepared to concentration according to oxygen sequence. Normoxia (3umol/min-1).
Drug: Sodium Nitrite
Active Comparator: Hypoxia and Nitrite (1umol/min-1)
This will be repeated as per the normoxia cohort, but at a reduced dose of sodium nitrite (1umol/min-1 for 30 minutes) and the volunteers will be asked to breathe 12% oxygen/88% nitrogen for 1-5 minutes before Plethysmography is performed (to get the volunteer to an oxygen saturation of 83-88% peripherally).
Drug: Sodium Nitrite
- Change in FBFR during intra-brachial nitrite and haemolysed blood co-infusion in normoxia vs hypoxia. [ Time Frame: Up to 18 months ]
- Change in FBFR during haemolysed blood infusion vs baseline [ Time Frame: Up to 18 months ]
- Change in FBFR during nitrite infusion in normoxia vs nitrite infusion in hypoxia [ Time Frame: Up to 18 months ]
- Change in FBFR during nitrite infusion in normoxia vs baseline [ Time Frame: Up to 18 months ]
- Change in FBFR during nitrite infusion in hypoxia vs baseline [ Time Frame: Up to 18 months ]
- Blood analysis (cell free haemoglobin, nitrate, nitrite and nitroso species levels) [ Time Frame: Up to 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077763
|Contact: Nicholas D Gollop, MRCP(UK)||01603 591790 ext firstname.lastname@example.org|
|University of East Anglia||Recruiting|
|Norwich, Norfolk, United Kingdom, NR4 7UQ|
|Contact: Nicholas D Gollop, MRCP 01603 591790 ext 1790 email@example.com|
|Principal Investigator:||Michael P Frenneaux, FRCP, FESC||Dean of Medicine, Norwich Medical School, The University of East Anglia, UK|