Exercise Capacity and Quality of Life in Patients With PPH Receiving Short Term Oral L-Citrulline Malate
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Aug 2012
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 12, 2013
September 1, 2012
1 year
September 1, 2012
August 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
2 weeks
Secondary Outcomes (1)
changes in mean pulmonary-artery pressure
2 weeks
Other Outcomes (1)
change in the quality of life
2 weeks
Study Arms (1)
L-Citrulline, Exercise Capacity
EXPERIMENTALL-Citrulline malate, 1gr, oral, divided 3 times a day,for 2 weeks
Interventions
3 gr per day, oral, for 2 weeks
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MasihDH
Tehran, 021, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiology Department of NRITLD, Associate Professor
Study Record Dates
First Submitted
September 1, 2012
First Posted
September 12, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
August 12, 2013
Record last verified: 2012-09