Exercise Capacity and Quality of Life in Patients With PPH Receiving Short Term Oral L-Citrulline Malate
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|ClinicalTrials.gov Identifier: NCT01683981|
Recruitment Status : Unknown
Verified September 2012 by babak sharif kashani, Masih Daneshvari Hospital.
Recruitment status was: Recruiting
First Posted : September 12, 2012
Last Update Posted : August 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Arterial Hypertension Eisenmenger Syndrome||Drug: L-Citrulline Malate||Early Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise Capacity and Quality of Life in Patients With Idiopathic Pulmonary Hypertension and Eisenmenger Syndrome Receiving Short Term Oral L-Citrulline Malate|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
Experimental: L-Citrulline, Exercise Capacity
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
Other Name: Stimol
- the change in exercise capacity [ Time Frame: 2 weeks ]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)
- changes in mean pulmonary-artery pressure [ Time Frame: 2 weeks ]changes in mean pulmonary-artery pressure from baseline to week 2.
- change in the quality of life [ Time Frame: 2 weeks ]change in the quality of life from baseline to week 2
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): NCT01683981
|Contact: babak sharif kashani, Cardiologistfirstname.lastname@example.org|
|Contact: paritash tahmasebpour, MDemail@example.com|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 021|
|Contact: babak sharif kashani, cardiologist 0098-02188883114 firstname.lastname@example.org|
|Contact: paritash tahmasebpour, MD 0098-09125037861 email@example.com|
|Principal Investigator: babak sharif kashani, cardiologist|
|Principal Investigator:||babak sharif kashani, cardiologist||Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Science, Tehran, Iran.|
|Principal Investigator:||Paritash Tahmaseb pour, MD||MD|