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Pulmonary Hypertension | Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease

Pulmonary Hypertension research study

What is the primary objective of this study?

Who is eligible to participate?

Inclusion Criteria: - Male and female U.S. Veteran patients 40-85 years old, with Gold Stage II COPD by pulmonary function testing (FEV1/FVC <0.70; performed within 6 months of recruitment. - Eligible subjects must have PH documented on transthoracic echocardiogram within 6 months of baseline visit demonstrating an RV systolic pressure >40mmHg. To confirm the presence of PH, a right-heart catheterization will be performed, with subjects randomized to treatment only if catheterization shows a: - mPAP >25 mm Hg - PVR >2.5 Wood units - pulmonary artery capillary wedge pressure 18 mm Hg or less at rest - PH belonging to the following subgroup of the updated Dana Point Clinical Classification: - Group 3 (PH associated with lung disease and/or hypoxemia) specifically, Group 3.1 (chronic obstructive pulmonary disease [COPD]) as the major criteria. Patients may also have minor clinical features associated with 3.2 (Interstitial disease) (such as mild fibrosis on high resolution chest CT, but total lung capacity>80% predicted) and 3.3 (sleep disordered breathing) (AHI <15 or 20/hour). - 6-minute walk distance between 50-450 meters at screening visit. Exclusion Criteria: - PH belonging to the following subgroups of the updated Dana Point Clinical Classification: Group 1 - Idiopathic - heritable - drug or toxin-induced - Associated Pulmonary Arterial Hypertension (APAH) with: - connective tissue disease - congenital heart disease - or HIV Group 2 - left atrial hypertension Group 4 - chronic thromboembolic PH - or other forms of PH not associated with primary lung disease Also - Patients with a history of systemic hypotension in the ambulatory setting (reproducible measurements of systolic blood pressure <89 mmHg) on chart review. - Patients with moderate or severe hepatic impairment (Child-Pugh B and C) - Patients with severe renal insufficiency (GFR <30 ml/min/1.73 m2) - Severe aortic stenosis (aortic valve area <1.0 cm2) - Patients with any acute or chronic impairment: - (other than dyspnea), limiting the ability to comply with the study requirements, including the 6-minute walk test and right heart catheterization. - Patients with a recent stroke - Patients with untreated hypoxemia (SaO2 <92%) at rest - Patients with untreated moderate or severe obstructive sleep apnea (AHI>15) - Patients with any coagulopathy - Patients requiring nitrate therapy for any clinical indication - Patients with an active prescription for pulmonary vasodilator medication other than oxygen - Patients with a history of nonarteritic anterior ischemic optic neuropathy - Contraindication to tadalafil use including allergy to: - any PDE-5 inhibitor - anatomical deformations of the penis - sickle cell anemia - multiple myeloma - leukemia - bleeding disorders - active peptic ulcer disease - retinitis pigmentosa or other retinal disorders.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pulmonary Hypertension

Chronic Obstructive Pulmonary Disease (COPD)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:TadalafilDaily use of study drug to treat pulmonary hypertension.

Drug:placeboDaily use in double blind study.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboPlacebo tablet

TadalafilDaily use of tadalafil (study drug) at 40 mg orally.

Study Status

Active, not recruiting

Start Date: October 1, 2013

Completed Date: August 31, 2019

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change in 6 minute walk test

Secondary Outcome: Maximum volume of oxygen extraction on exercise testing

Study sponsors, principal investigator, and references

Principal Investigator: Ronald Howard Goldstein, MD

Lead Sponsor: VA Office of Research and Development

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01862536

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