NCT07907757Not yet recruitingPhase 2
Colchicine in Pulmonary Artery Hypertension Patients
The Efficacy and Safety of Colchicine in Pulmonary Artery Hypertension Patients
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
This study evaluates the efficacy of colchicine in improving cardiopulmonary function for patients diagnosed with Pulmonary Arterial Hypertension (PAH), a condition characterized by elevated pulmonary pressure that impairs right ventricular performance. While current therapeutic interventions target pulmonary vasculature, right ventricular decline remains a clinical challenge. Colchicine, an anti-inflammatory agent typically indicated for gout and cardiovascular conditions, has demonstrated potential in preclinical models to mitigate mechanisms contributing to right heart failure. We are currently enrolling 60 adult PAH patients in a 12-week trial. Participants will be randomized into two cohorts: one receiving standard PAH therapy supplemented with a low daily dose of colchicine, and a control group receiving standard care exclusively. The primary objectives are to assess improvements in the 6-minute walk test, echocardiographic heart function, and circulating stress biomarkers, as well as the mitigation of disease progression. Furthermore, we will rigorously monitor patient safety and tolerability throughout the study duration.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- Ain Shams University
- NCT number
- NCT07907757
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 31 Oct 2026 to the primary completion date, 30 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 1\. Diagnosis of PH group 2, 3,4, or 5. 2. Known allergy to colchicine. 3. Unstable PAH requiring treatment escalation or hospitalization. 4. Listed for lung transplantation at the time of screening 5. Planned initiation of IV prostacyclin therapy or current dose escalation planned.
- 6\. Treatment with colchicine before recruitment. 7. Impaired renal function with an eGFR \< 30 mL/min/m2 within four weeks of screening.
- 8\. Severe liver dysfunction (Child-Pugh class C). 9. Patients with blood dyscrasias. 10. Concomitant strong CYP3A4 inhibitors. 11. Concomitant P-glycoprotein inhibitors. 12. Pregnancy or breastfeeding.
Who the study is looking for
- 1\. A diagnosis of PAH group 1 in any of the following subtypes:
- Idiopathic
- Heritable
- Associated with drugs and toxins
- Associated with
- Connective tissue disease
- Portal hypertension
- Congenital heart disease 2. Symptomatic PAH in WHO functional class II-III. 3. Clinically stable. Clinical stability is defined as the absence of symptom exacerbation, as determined by the treating physician, and no need for unplanned hospitalization due to worsening pulmonary hypertension within three months before the study.) 4. Fertile women (under 50 years of age) must use reliable contraception (such as intrauterine devices or hormonal contraceptives) throughout the study and must maintain a negative pregnancy test.
- 5\. Age ≥ 18 years. 6. Ability to perform cardio-pulmonary exercise test.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.