Phase 2
Completed N=42
Simvastatin as a Treatment for Pulmonary Hypertension
Source: ClinicalTrials.gov NCT00180713 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Aug 2019
Primary outcomePrimary: Change in Right Ventricular Mass From Baseline — 3.9; -5.2 grams — p=0.028
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Right Ventricular Mass From Baseline |
3.9; -5.2 | 0.028 sig |
| SECONDARY Change in 6-minute Walk Distance |
1; 3.1 | 0.86 |
| SECONDARY Change in LV Mass |
-1.3; 1.7 | 0.4 |
| SECONDARY Circulating Levels of BNP |
49; -75 | 0.041 sig |
| SECONDARY Change in Quality of Life Score |
0; -1.6 | 0.26 |
Eligibility Criteria
Inclusion Criteria
- Patients with idiopathic PAH or PAH related to collagen vascular disease
- Age 18 years or over
- Receiving conventional therapy with diuretics, digoxin, warfarin, sildenafil and bosentan. Stable for 1 month
- 6 minute walk distance between 150m and 450m
- Modified NYHA functional class II or III
Exclusion Criteria
- PAH from a cause other than permitted by entry criteria
- Change in PAH treatment in past 4 weeks
- Patients requiring prostanoid therapy
- Patients already taking a statin
- Clinically significant disturbance of liver function - AST or ALT >3xULM; bilirubin >1.5xULM
- Contraindication for a magnetic resonance scan
Data sourced from ClinicalTrials.gov (NCT00180713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.