Condition category
Circulatory System
Date applied
26/12/2006
Date assigned
26/01/2007
Last edited
15/04/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hanna Mach

ORCID ID

Contact details

Mittelweg 27
Frankfurt
60318
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STOP-PAH-001

Study information

Scientific title

Acronym

STOP-PAH

Study hypothesis

Six minute walk distance will be significantly enhanced in the atorvastatin patient group compared to the placebo patient group.

Ethics approval

Added 15/04/2009: This trial was never initiated and therefore no ethics approval was sought.

Study design

Randomised, prospective, double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pulmonary hypertension

Intervention

The treatment will be 40, 80 mg atorvastatin orally versus placebo, three months of treatment per patient.

Intervention type

Drug

Phase

Phase III

Drug names

Atorvastatin

Primary outcome measures

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 trial start date

01/04/2007

Overall trial end date

01/04/2009

Reason abandoned

Objectives no longer viable

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients

Participant 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

Recruitment start date

01/04/2007

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Austria, Germany, Netherlands, Switzerland

Trial participating centre

Mittelweg 27
Frankfurt
60318
Germany

Sponsor information

Organisation

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Sponsor details

c/o PD Dr. Ekkehard Grünig
Innere Medizin III
Neuenheimer Feld 410
INF 410
Heidelberg
69120
Germany
+49 (0)62 215 689 06
ekkehard.gruenig@med.uni-heidelberg.de

Sponsor type

Hospital/treatment centre

Website

http://www.klinikum.uni-heidelberg.de/

Funders

Funder type

Government

Funder name

European Union (EU) - Project "Pulmotension": this is an investigator initiated trial

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

Publication citations

Additional files

Editorial Notes