Phase 2 N=42 Randomized Quadruple-blind Treatment

Simvastatin as a Treatment for Pulmonary Hypertension

Pulmonary Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00180713 ↗

Enrolled (actual)

Serious AEs

2.4%

Results posted

Aug 2019

Primary outcome: Primary: Change in Right Ventricular Mass From Baseline — 3.9; -5.2 grams — p=0.028

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Simvastatin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Oct 2008

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

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.

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

View full record on ClinicalTrials.gov →

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.