Condition category
Circulatory System
Date applied
13/05/2006
Date assigned
14/06/2006
Last edited
02/02/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hanna Mach

ORCID ID

Contact details

c/o Dr Riethmüller M/R/S
Mittelweg 27
Frankfurt
60318
Germany

Additional identifiers

EudraCT number

2005-004863-41

ClinicalTrials.gov number

NCT00180713

Protocol/serial number

SIPHT-001; EudraCT number: 2005-004863-41

Study information

Scientific title

Acronym

SiPHT

Study hypothesis

Simvastatin is significantly effective in lowering the mean pulmonary arterial pressure versus placebo after six months of therapy.

Ethics approval

Ethics approval received from the Justus-Liebig-Universität Giessen Ethikkommittee des FB Medizin on the 30th August 2006 (ref: 85/06).

Study design

Double-blind, randomised, prospective, placebo-controlled (first phase, 6 months), open-label (second phase, 6 months) trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pulmonary hypertension

Intervention

Please note that as of 02/05/2008 the anticipated start date was updated. The previous anticipated start date was 01/08/2006.

Interventions:
Effects of simvastatin or placebo on haemodynamics (cardiac catheterisation), electrocardiogram (ECG), echocardiogram, cardiac magnetic resonance, lung function test etc.

Intervention type

Drug

Phase

Not Specified

Drug names

Simvastatin

Primary outcome measures

Pulmonary arterial pressure

Secondary outcome measures

1. Pulmonary vascular resistance
2. Cardiac output
3. Right ventricle mass
4. Six-minute walk test
5. Left ventricular (LV) systolic eccentricity index
6. Tei index
7. Right atrial area
8. Levels of brain natriuretic peptide (BNP) and inflammatory markers
9. Urinary iPF2alpha-III levels
10. Adverse events
11. Concomitant medication

Overall trial start date

16/07/2007

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female and male patients of any racial origin with pulmonary hypertension (PH)
2. Having fulfilled his/her 18th birthday on day 1 of the study
3. Modified New York Heart Association (NYHA) class II or III
4. PH due to idiopathic pulmonary arterial hypertension or collagen vascular disease associated PH
5. Cardiac catheterisation within the last year consistent with PH, specifically pulmonary artery mean pressure (PAPM) greater than or equal to 25 mmHg (at rest), pulmonary capillary wedge pressure (PCWP) (or left ventricular [LV] end diastolic pressure) less than or equal to 15 mmHg, and peripheral vascular resistance (PVR) greater than 3 mmHg/l/min
6. Echocardiogram on day 1 consistent with PH, more specifically, evidence of right ventricular hypertrophy or dilation, evidence of normal left ventricular function, and absence of mitral valve stenosis
7. Six-minute walk test between 150 and 450 m
8. Patients receiving conventional PH therapy. Stable for one month.
9. Able to understand and willing to sign the informed consent form
10. Negative pregnancy test (β-human chorionic gonadotropin [HCG]) at the start of the trial and appropriate contraception throughout the study for women of child-bearing potential

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients

Participant exclusion criteria

1. Pregnancy and/or lactation
2. PH of any cause other than permitted in the entry criteria
3. Contraindication for cardiac magnetic resonance (CMR) scan or heart catheterisation
4. Any change in disease-targeted therapy within the last four weeks
5. Patients requiring prostanoid therapy at the start of the study
6. Patients already taking a statin
7. Any subject who has received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
8. Known intolerance to hydroxy-methylglutaryl coenzyme A (HMG-CoA)-inhibitors (statins) or any of the excipients
9. Active liver disease, porphyria or elevations of serums transaminases greater than three times upper limit of normal (ULN) or bilirubin greater than 1.5 x ULN
10. Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, human immunodeficiency virus [HIV] protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone, ciclosporin and danazole)
11. History or suspicion of inability to cooperate adequately

Recruitment start date

16/07/2007

Recruitment end date

31/07/2008

Locations

Countries of recruitment

Germany

Trial participating centre

c/o Dr Riethmüller M/R/S
Frankfurt
60318
Germany

Sponsor information

Organisation

University Hospital Giessen (Germany)

Sponsor details

University Hospital Giessen
Medical Clinic II
Department of Internal Medicine
Klinikstrasse 36
Giessen
35392
Germany
+49 (0)641 9942 421
ardeshir.ghofrani@innere.med.uni.giessen.de

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Hospital Giessen (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20110553

Publication citations

Additional files

Editorial Notes