Clinical investigation into efficacy, haemodynamics and tolerability of simvastatin versus placebo in patients with pulmonary arterial hypertension
| ISRCTN | ISRCTN27178415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27178415 |
| EudraCT/CTIS number | 2005-004863-41 |
| ClinicalTrials.gov number | NCT00180713 |
| Secondary identifying numbers | SIPHT-001; EudraCT number: 2005-004863-41 |
- Submission date
- 13/05/2006
- Registration date
- 14/06/2006
- Last edited
- 02/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hanna Mach
Scientific
Scientific
c/o Dr Riethmüller M/R/S
Mittelweg 27
Frankfurt
60318
Germany
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SiPHT |
| Study objectives | Simvastatin is significantly effective in lowering the mean pulmonary arterial pressure versus placebo after six months of therapy. |
| Ethics approval(s) | Ethics approval received from the Justus-Liebig-Universität Giessen Ethikkommittee des FB Medizin on the 30th August 2006 (ref: 85/06). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Simvastatin |
| Primary outcome measure | 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 study start date | 16/07/2007 |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/07/2007 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
c/o Dr Riethmüller M/R/S
Frankfurt
60318
Germany
60318
Germany
Sponsor information
University Hospital Giessen (Germany)
University/education
University/education
University Hospital Giessen
Medical Clinic II
Department of Internal Medicine
Klinikstrasse 36
Giessen
35392
Germany
| Phone | +49 (0)641 9942 421 |
|---|---|
| ardeshir.ghofrani@innere.med.uni.giessen.de | |
"ROR" |
https://ror.org/032nzv584 |
Funders
Funder type
University/education
University Hospital Giessen (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/05/2010 | Yes | No |
