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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Hypertension; COPD
• Intervention / Treatment: Drug: Sildenafil Citrate; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
      • Contact: Guohua Hu, MD; Phone Number: 13517277794; Email: guohuazhen@hotmail.com
      • Contact: Phone Number: 13517277794; Email: guohuazhen@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary artery pressure	pressure in mmHg	12 weeks
pulmonary vascular resistance	woods	12 weeks

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 11, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 11, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: 2016YFC1304401B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No