NCT00180713

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

August 21, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

September 12, 2005

Results QC Date

July 11, 2019

Last Update Submit

August 20, 2019

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertensionSimvastatinStatins

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change in 6-minute Walk Distance

    6 months

  • Change in LV Mass

    6 months

  • Circulating Levels of BNP

    6 months

  • Change in Quality of Life Score

    6 months

Study Arms (2)

Arm 1: Control

PLACEBO COMPARATOR

Placebo tablet once daily

Drug: Placebo

Arm 2: Experimental

EXPERIMENTAL

Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.

Drug: Simvastatin

Interventions

SimvastatinDRUG

Simvastatin 40mg od for 1 month, then 80mg od for 11 months

Also known as: Zocor
Arm 2: Experimental
PlaceboDRUG

Placebo tablet once daily.

Arm 1: Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • minute walk distance between 150m and 450m
  • Modified NYHA functional class II or III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Internal Medicine II, Klinikstrasse 36 D-35392

Giessen, Germany

Location

Royal Brompton Hospital, Sydney Street

London, SW3 6NP, United Kingdom

Location

Hammersmith Hospital, Du Cane Road

London, W12 0NN, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 20460548RESULT

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Professor Martin R Wilkins
Organization
Imperial College London
m.wilkins@imperial.ac.uk
+44 (0)20 8383 2049

Study Officials

  • Martin Wilkins, MD FRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2008

Study Completion

May 1, 2009

Last Updated

August 21, 2019

Results First Posted

August 21, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)GB(2)