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Influence of RYANodyne receptor 1 mutations On Pulmonary arterial Pressure And ventilation During isocapnic hypoxia.


- candidate number9130
- NTR NumberNTR2784
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2011
- Secondary IDsP11.013 / NL35083.058.11; METC LUMC / CCMO
- Public TitleInfluence of RYANodyne receptor 1 mutations On Pulmonary arterial Pressure And ventilation During isocapnic hypoxia.
- Scientific TitleInfluence of RYANodyne receptor 1 mutations On Pulmonary arterial Pressure And ventilation During isocapnic hypoxia.
- ACRONYMRyan op pad
- hypothesis1. What are the normoxic ventilation parameters and systolic PAP in MH patients?
2. What is the influence of hypoxia on the systolic PAP on MH patients?
- Healt Condition(s) or Problem(s) studiedHypoxia, Malignant hyperthermia, Hypoxic ventilatory response, Hypoxic pulmonary vasoconstriction
- Inclusion criteriaHealthy Malignant Hyperthermia patients with a phenotypic high susceptibility and a proven causative mutation. The major inclusion criteria are that the subject has echo evidence of tricuspid regurgitation during systole, which is not clinically relevant but in fact can be demonstrated in most normal individuals.
- Exclusion criteria1. Obesity (BMI > 30);
2. Presence of medical disease: heart-, lung-, liver-, kidney- and lung disease; diabetes;
3. Presence of psychiatric disease:
A. History of chronic alcohol or drug use;
B. Possibility of pregnancy;
C. Lactation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate1-mei-2013
- Target number of participants24
- InterventionsOne hypoxic period of 1 hour.
- Primary outcome1. Systolic PAP;
2. HVR.
- Secondary outcome1. Systolic and diastolic cardiac functions;
2. Vital and ventilatory parameters.
- Timepoints1 hour.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. Rob Lindeman
- CONTACT for SCIENTIFIC QUERIESMD. Rob Lindeman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThe ryanodine receptor plays a crucial role in the development of the so called hypoxic pulmonary vasoconstriction. Malignant hyperthermia patients have a mutated ryanodine receptor. In this study we want to investigate the influence of the ryanodine receptor on the human response to hypoxia.
- Main changes (audit trail)
- RECORD17-feb-2011 - 11-mrt-2011


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