The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD

COPD Clinical Trial

Official title:

The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03185364
• Other study ID #: 2016YFC1304401B
• Status: Recruiting
• Phase: N/A
• First received: June 11, 2017
• Last updated: June 11, 2017
• Start date: June 15, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by COPD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Stable for over 1 month

• mean pulmonary artery pressure =35mmHg, pulmonary wedge pressure= 15mmHg

• never received target therapy before

Exclusion Criteria:

• Patients with other serious respiratory diseases

• Patients with pulmonary hypertension other than group 3

• Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases

• Patients with limited life expectancy

• Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months

• Psychopath or addict

• Nonstable patients with type ?or ? respiratory failure

• Patients with contraindication for sildenafil

• Patients in pregnancy or breastfeeding

Related Conditions & MeSH terms

• COPD
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Sildenafil Citrate
sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events
• Placebo Oral Tablet
placebos treatment for 12 weeks

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary artery pressure	pressure in mmHg	12 weeks
Primary	pulmonary vascular resistance	woods	12 weeks