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

Primary Purpose

COPD, Pulmonary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sildenafil Citrate
Placebo Oral Tablet
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interventional group

Control group

Arm Description

Sildenafil Citrate, 20mg, tid for 12 weeks

placebo oral tablet, 12 weeks

Outcomes

Primary Outcome Measures

pulmonary artery pressure
pressure in mmHg
pulmonary vascular resistance
woods

Secondary Outcome Measures

Full Information

First Posted
June 11, 2017
Last Updated
June 11, 2017
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03185364
Brief Title
The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
Official Title
The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Sildenafil Citrate, 20mg, tid for 12 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
placebo oral tablet, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate
Intervention Description
sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
placebos treatment for 12 weeks
Primary Outcome Measure Information:
Title
pulmonary artery pressure
Description
pressure in mmHg
Time Frame
12 weeks
Title
pulmonary vascular resistance
Description
woods
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Hu, MD
Phone
13517277794
Email
guohuazhen@hotmail.com
Phone
13517277794
Email
guohuazhen@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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