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

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masih Daneshvari Hospital

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.