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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
Sponsor:
Information provided by (Responsible Party):
babak sharif kashani, Masih Daneshvari Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2012
First Posted Date  ICMJE September 12, 2012
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01683981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
changes in mean pulmonary-artery pressure [ Time Frame: 2 weeks ]
changes in mean pulmonary-artery pressure from baseline to week 2.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 20, 2012)
change in the quality of life [ Time Frame: 2 weeks ]
change in the quality of life from baseline to week 2
Original Other Pre-specified Outcome Measures
 (submitted: September 11, 2012)
  • change in the quality of life [ Time Frame: 2 weeks ]
    change in the quality of life from baseline to week 2
  • the change in the frequency of admission [ Time Frame: 2 weeks ]
    the change in the frequency of admission from baseline to week 2.
 
Descriptive Information
Brief Title  ICMJE Exercise Capacity and Quality of Life in Patients With PPH Receiving Short Term Oral L-Citrulline Malate
Official Title  ICMJE Exercise Capacity and Quality of Life in Patients With Idiopathic Pulmonary Hypertension and Eisenmenger Syndrome Receiving Short Term Oral L-Citrulline Malate
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Idiopathic Pulmonary Arterial Hypertension
  • Eisenmenger Syndrome
Intervention  ICMJE Drug: L-Citrulline Malate
3 gr per day, oral, for 2 weeks
Other Name: Stimol
Study Arms  ICMJE Experimental: L-Citrulline, Exercise Capacity
L-Citrulline malate, 1gr, oral, divided 3 times a day,for 2 weeks
Intervention: Drug: L-Citrulline Malate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2012)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all patients less than 70 years old,
  • patients with a six-minute walking distance of more than 100 meters (m),
  • a mean pulmonary arterial pressure (PAP) ≥ 25 mmHg at rest as assessed by right heart catheterization(RHC) (11,12).

Exclusion Criteria:

  • all patients more than 70 years old,
  • patients with a six-minute walking distance of less than 100 meters (m), active pulmonary or extra pulmonary infection,
  • serious coronaropathy and/ or ventricular dysfunction,
  • significant renal illness and/or hepatitis,
  • detected immunosuppressive illnesses,
  • carrier of known neoplasias,
  • pregnancy,
  • lack of family support,
  • psychosocial problems,
  • drug or alcohol abuse, and
  • noncompliance with established medical protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01683981
Other Study ID Numbers  ICMJE f-91-138
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party babak sharif kashani, Masih Daneshvari Hospital
Study Sponsor  ICMJE Masih Daneshvari Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Masih Daneshvari Hospital
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP