Exercise Capacity and Quality of Life in Patients With PPH Receiving Short Term Oral L-Citrulline Malate

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01683981
• Date of registration: 01/09/2012
• Prospective Registration: No
• Primary sponsor: Masih Daneshvari Hospital
• Public title: Exercise Capacity and Quality of Life in Patients With PPH Receiving Short Term Oral L-Citrulline Malate
• Scientific title: Exercise Capacity and Quality of Life in Patients With Idiopathic Pulmonary Hypertension and Eisenmenger Syndrome Receiving Short Term Oral L-Citrulline Malate
• Date of first enrolment: August 2012
• Target sample size: 25
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01683981
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 0

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Paritash Tahmaseb pour, MD
• Affiliation: MD

• Name: babak sharif kashani, Cardiologist

• Name: babak sharif kashani, cardiologist

• Name: babak sharif kashani, cardiologist
• Affiliation: Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Science, Tehran, Iran.

Key inclusion & exclusion criteria

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.



Age minimum: 15 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Eisenmenger Syndrome

Idiopathic Pulmonary Arterial Hypertension

Intervention(s)

Drug: L-Citrulline Malate

Primary Outcome(s)

the change in exercise capacity [Time Frame: 2 weeks]

Secondary Outcome(s)

changes in mean pulmonary-artery pressure [Time Frame: 2 weeks]

Secondary ID(s)

f-91-138

Source(s) of Monetary Support

Please refer to primary and secondary sponsors