An Early Phase 1 interventional study of L-Citrulline Malate in Idiopathic Pulmonary Arterial Hypertension and Eisenmenger Syndrome, sponsored by Masih Daneshvari Hospital. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Masih Daneshvari Hospital · Early Phase 1 and Interventional
Due to vasodilatory properties of the NO, one of the therapeutic approaches for IPAH is oral use of nitric oxide precursors (10). Efficacy of L-arginine is well-documented in the current literature but there is paucity of data with regard to L-citrulline- malate. Hence, this study will evaluate therapeutic efficacy of L-citrulline- malate in two categories of patients with pulmonary hypertension (IPAH, and Eisenmeger syndrome). This randomized clinical trial utilizes 6-minute walk, pro BNP levels and the echocardiographic indexes an indicator of functional improvement of the patients.
Pulmonary vascular tone is maintained by the action of vasoprotective compounds including nitric oxide (NO)(1).NO can be synthesized endogenously in the body via L-arginine and NOS-independent mechanism from the anion nitrite (NO2-)(2,3).Nitric oxide (NO) causes cyclic guanosine monophosphate-mediated vasodilatation of the pulmonary vasculature. Endogenous NO is also produced from the metabolism of citrulline; an amino acid generated by the urea cycle (4). NO is critical for normal development of the pulmonary vasculature and loss of this vasodilator factor and subsequent endothelial dysfunction is proposed as one of the possible explanations for development of pulmonary hypertension (1).
From a clinical standpoint, pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD).Its presence is associated with shorter survival and worse clinical outcome. In a setting of COPD, pulmonary hypertension tends to be of moderate severity and progresses slowly. Recent investigations have demonstrated endothelial dysfunction and changes in the expression of endothelial-derived mediators that regulate vascular tone and cell growth in the pulmonary arteries of patients with mild disease(5). Pulmonary vascular involvement from congenital heart disease like Eisenmeger syndrome is another important category of patients with PAH. In this congenital disease pulmonary vascular involvement follows a period in which pulmonary resistance is low and pulmonary blood flow is high (6, 7, 8). Finally, Idiopathic pulmonary hypertension (IPAH) is the third category of these patients. IPAH has unknown etiology and is characterized by progressive obliteration of small and medium size pulmonary arteries; elevation in pulmonary arterial pressure, and an increase in pulmonary vascular resistance. Presence of these pathologies eventually leads to right heart failure and death (9).
23 studies on the registry are indexed under Eisenmenger Complex; 5 are open to participants now.
This study's planned enrollment of 25 is below the median of 40 across 15 interventional studies indexed under Eisenmenger Complex.
Browse Eisenmenger Complex studies →Masih Daneshvari Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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L-Citrulline malate, 1gr, oral, divided 3 times a day,for 2 weeks
Drug: L-Citrulline Malate
3 gr per day, oral, for 2 weeks
Also known as: Stimol
the change in exercise capacity
The primary measure of efficacy was the change in exercise capacity, as measured by the total distance walked in six minutes, from baseline to week 2. (15)
Time frame: 2 weeks
changes in mean pulmonary-artery pressure
changes in mean pulmonary-artery pressure from baseline to week 2.
Time frame: 2 weeks
change in the quality of life
change in the quality of life from baseline to week 2
Time frame: 2 weeks
The record gives a start of Aug 2012, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Citrulline malate
Masih Daneshvari Hospital