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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Ⅰor Ⅱ respiratory failure.

- Patients with contraindication for sildenafil.

- Patients in pregnancy or breastfeeding

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03185364
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chinese Academy of Medical Sciences, Fuwai Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	COPD, Pulmonary Hypertension

Arms & Interventions

Arms

Experimental: Interventional group

Sildenafil Citrate, 20mg, tid for 12 weeks

Placebo Comparator: Control group

placebo oral tablet, 12 weeks

Interventions

Drug: - Sildenafil Citrate

sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events

Drug: - Placebo Oral Tablet

placebos treatment for 12 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.