UnknownEarly Phase 1

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

Iran25 participantsStarted 2012-08

Plain-language 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.

Who can participate

Age range

15 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the change in exercise capacity

Timeframe: 2 weeks

Trial details

NCT IDNCT01683981

SponsorMasih Daneshvari Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

Contact for this trial

babak sharif kashani, Cardiologist

0098-02188883114 sharifk@nritld.ac.ir

View on ClinicalTrials.gov More Idiopathic Pulmonary Arterial Hypertension trials