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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
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The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension.
Pulmonary arterial hypertension (PAH) is a disease that is characterised by progressive narrowing of the blood vessels of the lungs. This results in a pressure load on the heart and heart failure.
The narrowing is in part due to constriction but mostly due to structural changes in affected vessels. The structural changes affect all cell components of the vessel wall (the endothelial lining, the muscle layer and fibrous tissue) and can lead to local clot formation. In addition there is evidence of inflammation of the vessels and what is known as oxidative stress. The disease may occur with no obvious cause, when it is known as idiopathic, but it can also be associated with a variety of other diseases, including congenital heart disease, collagen vascular disease and HIV infection.
Current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above. Alternative or additional treatments are therefore required and an attrative approach is to use a statin (a 3-hydroxy-3-methylglutaryl-coenzymeA, or HMG-CoA, reductase inhibitor). Statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation, clot formation and oxidative stress - that might be beneficial in pulmonary hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Control | Placebo Comparator | Placebo tablet once daily |
|
| Arm 2: Experimental | Experimental | Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Simvastatin 40mg od for 1 month, then 80mg od for 11 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Right Ventricular Mass From Baseline | As measured by cardiac magnetic resonance (the study is powered to detect an 8.5g difference in RV mass between the two treatments, based on reproducibility measurements of RV mass in healthy volunteers and patients) | 6 months post study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute Walk Distance | Change in distance achieved in 6 minute walk test from baseline | 6 months |
| Change in LV Mass | Change in LV mass from baseline based on cardiac MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Wilkins, MD FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine II, Klinikstrasse 36 D-35392 | Giessen | Germany | ||||
| Royal Brompton Hospital, Sydney Street |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20460548 | Result | Wilkins MR, Ali O, Bradlow W, Wharton J, Taegtmeyer A, Rhodes CJ, Ghofrani HA, Howard L, Nihoyannopoulos P, Mohiaddin RH, Gibbs JS; Simvastatin Pulmonary Hypertension Trial (SiPHT) Study Group. Simvastatin as a treatment for pulmonary hypertension trial. Am J Respir Crit Care Med. 2010 May 15;181(10):1106-13. doi: 10.1164/rccm.2009111-699oc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Control | Placebo tablet once daily Placebo: Placebo tablet once daily. |
| FG001 | Arm 2: Experimental | Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months. Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Control | Placebo tablet once daily Placebo: Placebo tablet once daily. |
| BG001 | Arm 2: Experimental | Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months. Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Right Ventricular Mass From Baseline | As measured by cardiac magnetic resonance (the study is powered to detect an 8.5g difference in RV mass between the two treatments, based on reproducibility measurements of RV mass in healthy volunteers and patients) | Posted | Mean | Standard Deviation | grams | 6 months post study treatment |
|
Adverse events were collected from date of consent until the final study visit after a year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Control | Placebo tablet once daily Placebo: Placebo tablet once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Creatinine Kinase | Investigations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Martin R Wilkins | Imperial College London | +44 (0)20 8383 2049 | m.wilkins@imperial.ac.uk |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Placebo tablet once daily. |
|
| 6 months |
| Circulating Levels of BNP | Change in NT-proBNP levels compared to baseline | 6 months |
| Change in Quality of Life Score | Change in quality of life score from baseline as measured by Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) scored from 1-25, with higher scores indicating worse quality of life, the investigator reported the score change. | 6 months |
| London |
| SW3 6NP |
| United Kingdom |
| Hammersmith Hospital, Du Cane Road | London | W12 0NN | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in 6-minute Walk Distance | Change in distance achieved in 6 minute walk test from baseline | Posted | Mean | Standard Deviation | metres | 6 months |
|
|
|
|
| Secondary | Change in LV Mass | Change in LV mass from baseline based on cardiac MRI | Posted | Mean | Standard Deviation | grams | 6 months |
|
|
|
|
| Secondary | Circulating Levels of BNP | Change in NT-proBNP levels compared to baseline | Posted | Mean | Standard Deviation | fmol/ml | 6 months |
|
|
|
|
| Secondary | Change in Quality of Life Score | Change in quality of life score from baseline as measured by Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) scored from 1-25, with higher scores indicating worse quality of life, the investigator reported the score change. | Posted | Mean | Standard Deviation | change of score | 6 months |
|
|
|
|
| 1 |
| 23 |
| 0 |
| 23 |
| EG001 | Arm 2: Experimental | Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months. Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months | 0 | 19 | 2 | 19 |
Standard terms of model non-commercial agreement for UK clinical research apply.
| D002318 |
| Cardiovascular Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |