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

NCT03185364 | Unknown DMC

• 1 other identifier: 2016YFC1304401B
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• pulmonary artery pressure

  pressure in mmHg

  12 weeks

• pulmonary vascular resistance

  woods

  12 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

Sildenafil Citrate, 20mg, tid for 12 weeks

Drug: Sildenafil Citrate

Control group

PLACEBO COMPARATOR

placebo oral tablet, 12 weeks

Drug: Placebo Oral Tablet

Interventions

Sildenafil Citrate DRUG

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

Interventional group

Placebo Oral Tablet DRUG

placebos treatment for 12 weeks

Control group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable for over 1 month
• mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg
• never received target therapy before

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pulmonary Vascular Disease Center

Model Details: 23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 14, 2017
• Study Start: June 15, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

CN (1)