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

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ClinicalTrials.gov Identifier: NCT03185364
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Pulmonary Hypertension Drug: Sildenafil Citrate Drug: Placebo Oral Tablet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional group
Sildenafil Citrate, 20mg, tid for 12 weeks
Drug: Sildenafil Citrate
sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events

Placebo Comparator: Control group
placebo oral tablet, 12 weeks
Drug: Placebo Oral Tablet
placebos treatment for 12 weeks




Primary Outcome Measures :
  1. pulmonary artery pressure [ Time Frame: 12 weeks ]
    pressure in mmHg

  2. pulmonary vascular resistance [ Time Frame: 12 weeks ]
    woods



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185364


Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Guohua Hu, MD    13517277794    guohuazhen@hotmail.com   
Contact    13517277794    guohuazhen@hotmail.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital

Responsible Party: Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03185364     History of Changes
Other Study ID Numbers: 2016YFC1304401B
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Citric Acid
Sildenafil Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents