Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Arterial Hypertension: double-blinded, randomised, prospective phase III-b study for 12 weeks with adjusted doses of atorvastatin (40 - 80 mg daily)
| ISRCTN | ISRCTN63558875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63558875 |
| Secondary identifying numbers | STOP-PAH-001 |
- Submission date
- 26/12/2006
- Registration date
- 26/01/2007
- Last edited
- 15/04/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hanna Mach
Scientific
Scientific
Mittelweg 27
Frankfurt
60318
Germany
Study information
| Study design | Randomised, prospective, double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | STOP-PAH |
| Study objectives | Six minute walk distance will be significantly enhanced in the atorvastatin patient group compared to the placebo patient group. |
| Ethics approval(s) | Added 15/04/2009: This trial was never initiated and therefore no ethics approval was sought. |
| Health condition(s) or problem(s) studied | Pulmonary hypertension |
| Intervention | The treatment will be 40, 80 mg atorvastatin orally versus placebo, three months of treatment per patient. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure | Six minute walk test after 12 weeks of treatment compared to baseline. |
| Secondary outcome measures | 1. Short Form health survey (SF-36) 2. Borg scale 3. Modified NYHA class 4. Laboratory parameters 5. Adverse events 6. Concomitant medication |
| Overall study start date | 01/04/2007 |
| Completion date | 01/04/2009 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 patients |
| Key inclusion criteria | 1. Female and male patients of any racial origin with pulmonary arterial hypertension (PAH) 2. Having fulfilled his/her 18th birthday on day one of the study 3. Modified New York Heart Association (NYHA) functional class II and III 4. Unencouraged six minute walking distance at baseline less than 500 m 5. Symptomatic PAH due to idiopathic or familial PAH or associated with corrected congenital systemic-to-pulmonary shunts, drugs, toxins and collagen tissue disease (scleroderma, mixed collagenosis) 6. PAH diagnosed by right heart catheter showing: 6.1. Mean pulmonary arterial pressure (mPAP) more than 25 mmHg 6.2. Pulmonary capillary wedge pressure (PCWP) less than 15 mmHg 6.3. Pulmonary vascular resistance (PVR) at baseline of more than 320 dyne*sec/cm^5 7. Patient stable for at least eight weeks before enrolment 8. Able to understand and willing to sign the informed consent form 9. Negative pregnancy test at the start of the trial and highly effective contraception (oral or injectable contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomised partner) throughout the study for women with child-bearing potential |
| Key exclusion criteria | 1. Pregnancy and/or lactation 2. Women of child-bearing potential not using appropriate contraceptive measures 3. PAH of any cause other than permitted in the entry criteria 4. Suspected pulmonary veno-occlusive disease based on pulmonary oedema during a previous vasoreactivity test or on abnormal findings compatible with that diagnosis (septal lines or pulmonary oedema at high resolution computer tomography) 5. Myopathy 6. Any change in disease-targeted therapy and calcium-channel-blockers within the last four weeks 7. Patients already taking a statin or fibrates 8. Any subject who had received any investigational medication within one month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study 9. Known hypersensitivity to hydroxymethylglutaryl-coenzyme A (HMG-CoA)-inhibitors (statins) or any of the excipients 10. Active liver disease or unexplained persistent elevations of serums transaminases, gamma-glutamyl transpeptidase (gGT), alkaline phosphatase (AP) more than three x upper limit of normal (ULN) and elevations of creatine kinase (CK) more than two x ULN 11. History or suspicion of inability to cooperate adequately 12. Systolic blood pressure less than 85 mmHg 13. Body weight less than 40 kg |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Austria
- Germany
- Netherlands
- Switzerland
Study participating centre
Mittelweg 27
Frankfurt
60318
Germany
60318
Germany
Sponsor information
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o PD Dr. Ekkehard Grünig
Innere Medizin III
Neuenheimer Feld 410, INF 410
Heidelberg
69120
Germany
| Phone | +49 (0)62 215 689 06 |
|---|---|
| ekkehard.gruenig@med.uni-heidelberg.de | |
| Website | http://www.klinikum.uni-heidelberg.de/ |
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
Government
European Union (EU) - Project "Pulmotension": this is an investigator initiated trial
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 |
