Atorvastatin in Pulmonary Arterial Hypertension - Full Text View

Sponsored by:	Cardiovascular Institute & Fuwai Hospital
Information provided by:	Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:	NCT00615823

Purpose

Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Arterial Hypertension: double-blinded, randomised, prospective phase II study for 6 months with adjusted doses of Atorvastatin

Condition	Intervention	Phase
Hypertension, Pulmonary	Drug: atorvastatin Drug: placebo	Phase II

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Effect and Tolerability of Atorvastatin Versus Placebo in Patients With Pulmonary Arterial Hypertension: Double-Blinded, Randomised, Prospective Phase II Study for 6 Months With Adjusted Doses of Atorvastatin

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:

Distance walked in six minutes [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mean pulmonary arterial pressure [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]
cardiac index [ Time Frame: measured at 6 monthes ] [ Designated as safety issue: No ]
heart rate [ Time Frame: measured at 6 monthes ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: measured at 6 monthes ] [ Designated as safety issue: No ]
Borg scale [ Time Frame: measured at 6 monthes ] [ Designated as safety issue: No ]
Time to clinical events [ Time Frame: measured at 6 monthes ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator atorvastatin	Drug: atorvastatin atorvastatin prescribed orally at a starting dose of 10 mg, once a day for 1 months, and increased to 20 mg, once a day for 5 months
2: Placebo Comparator Placebo	Drug: placebo Placebo, taken orally, once a day for 6 months

Detailed Description:

PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. Several research have proved that inflammation may participate in the pathogenesis of PAH. As atorvastatin inhibits inflammation and has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, atorvastatin may similarly benefit patients with PAH. Experimental data suggest that statins attenuates pulmonary hypertension in animal experiments. In addition, non-controlled clinical studies suggest that atorvastatin is effective and safe in patients with pulmonary hypertension.

Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets or daily atorvastatin in a double-blind fashion. The study will compare the safety and efficacy of placebo and atorvastatin.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Able to understand and willing to sign the informed consent form
<=65 and >=18years old
Diagnosis of pulmonary arterial hypertension (Mean pulmonary artery pressure greater than 25 mm Hg at rest with a pulmonary capillary wedge pressure less than 15 mm Hg )that is a) idiopathic, b) familial, or c) associated with connective-tissue disease, d)congenital systemic-to-pulmonary shunt occurring after surgical/interventional repair that had been performed at least five years previously or in the absence of indications for surgery/intervention treatment e) chronic thromboembolism PAH in the absence of indications for surgery
Clinical diagnosis of pulmonary arterial hypertension in New York Heart Association (NYHA) or WHO functional class II to III
Vasodilator Testing nonresponders
Base-line six-minute walking distance between 100 and 450 m

Exclusion Criteria:

PAH related to other etiologies
Most recent pulmonary function tests showing FEV1/FVC ratio less than 50%, or total lung capacity less than 60% predicted
Low density lipoprotein-cholesterol (LDL-C)<70mg/dl
History or suspicion of inability to cooperate adequately
Current treatment (less than 3 months) with statins, prostanoids, endothelin antagonist, L-arginine, and phosphodiesterase inhibitors therapy
Unable to perform six-minute walk testing because of limitations in musculoskeletal function or abnormalities of other organs (except of heart and lung disease)
History of bleeding diathesis, gastrointestinal bleeding within 6 months, intracranial bleeding , trauma or other disease that has high risk of bleeding.
Serum transaminase greater than 3 times the upper limit of normal or Creatine phosphokinase (CPK) greater than 5 times the upper limit of normal at screening
Other heart disease including: serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction within 6 months, or New York Heart Association (NYHA) functional class Ⅳ
History of transient ischemia attach or stroke within 3 months
>65 or <18years old
Known hypersensitive or intolerance to atorvastatin
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615823

Contacts

Contact: Yinghua Guo, PHD	8601088398931	guoyinghuasmile@163.com
Contact: Jianguo He, MD	8601088398060	jianguohepumc@163.com

Locations

China
Cardiovascular Institute and Fu Wai Hospital	Recruiting
Beijing, China, 100037
Contact: Jianguo He, MD 86 01088398060 jianguohepumc@163.com
Principal Investigator: Jianguo He, MD

Sponsors and Collaborators

Cardiovascular Institute & Fuwai Hospital

Investigators

Study Chair:

Jianguo He, MD

Cardiovascular Institute & Fuwai Hospital

More Information

Responsible Party:	Cardiovascular Institute & Fuwai Hospital ( Jianguo He / Chief of Pulmonary Circulation Department )
Study ID Numbers:	2006-1152, 2006BAI01A07
Study First Received:	February 4, 2008
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00615823
Health Authority:	China: Ministry of Health

Keywords provided by Cardiovascular Institute & Fuwai Hospital:

Pulmonary Arterial Hypertension

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Atorvastatin
Hypertension

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009