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CLINICAL TRIALS

 

Pulmonary hypertension is an active area with respect to clinical trials of new pharmacological agents. Only the initial trial of intravenous epoprostenol has used survival as an outcome measure. Following this study surrogate markers of outcome especially six minute walk distance have been used. Most of the currently active trials involve combinations of the different disease targeted therapies or allow the possibility of combination therapy. The major exception to this are patients with Dana Point Group II - IV pulmonary hypertension (i.e. not pulmonary arterial hypertension) where monotherapy is not yet proven.

 

Randomised Controlled Trials of Disease Targeted Treatment in Progress in Adults

 

a) IPAH & APAH

 

Sponsor Trial Name Intervention Inclusion Criteria Other Disease Targeted Treatment Allowed Duration Target for Recruit- ment
Georgetown University Bosentan SSc with exercise induced PH

No

16 weeks

40

Actelion COMPASS 2 Bosentan added to Sildenafil IPAH, FPAH, APAH, on sildenafil for minimum of 12 weeks

No

16 weeks

250

Bayer PATENT 2 Riociguat IPAH

Yes

12 weeks + extension

462

United Therapeutics ATPAHSS Tadalafil and/or ambrisentan Systemic Sclerosis with pulmonary hypertension, WHO II or III

No

36 weeks

63

Novartis Pharma-ceuticals IMPRES Imatinib IPAH, WHO II to IV

Yes

24 weeks

200

Virginia Common-wealth University Carvedilol IPAH or assoc PAH, WHO II to IV

Yes

6 months

24

Pfizer Bosentan +/- sildenafil PAH

Yes

12 weeks

106

University of Heidelberg Still recruiting The influence of respiratory and exercise therapy on oxygen uptake, quality of life and right ventricular function PAH

Yes

15 weeks

90

University of Heidelberg Still recruiting The influence of respiratory and exercise therapy on 6 minute walk distance and quality of life PAH

Yes

16 weeks

34

Hospital de Clinicas de Porto Alegre Still recruiting Inspiratory muscle training PAH

Yes

8 weeks

34

University of Heidelberg Still recruiting Exercise training PAH

Yes

16 weeks

34

Hannover Medical School Still recruiting 3 week In-patient rehabilitation programme PAH

Yes

3 weeks

100

Seoul National University Still recruiting ULTIMATE Udenafil Mild Pulmonary Hypertension

Yes

12 weeks

40

Golden Jubilee National Hospital Still recruiting Apelin Infusion IPAH

Yes

1 day (exploratory study)

63

The Cleveland Clinic Ongoing but not recruiting Oral iron supplementation IPAH plus iron defficiency

Yes

12 weeks

25

Actelion Still recruiting GRIPHON Selexipag PAH

Yes

6 months plus extended study period; long term extension follows on

670

Hillel Yaffe Medical Centre Unknown Normatec? pump Right heart failure and leg oedema

Yes

5 days

20

University of Alberta Still recruiting First to Humans, Phase I study. Imperial College also particpating Dichloroacetate (DCA) IPAH, FPAH, APAH

Yes

16 weeks

40

Rabin Medical Centre Not yet recruiting Vardenafil PAH

Iloprost

14 weeks

20

Stanford University Unknown Tadalafil, Tyvaso; in combination or stand alone therapy IPAH

No

48 weeks

30

Stanford University Still recruiting Tacrolimus (effect on BMPRII signalling) IPAH, FPAH, CTDPAH, CHDPAH, APAH, porto pulmonary PH

Yes, but bosentan excluded

16 weeks

40

National Institutes of Health Clinical Centre Still recruiting Spironolactone (effect on inflammation and blood vessel function) PAH

Yes

24 weeks

70

GSK Still recruiting AMBITION Tadalafil, ambrisentan; in combination or stand alone therapy PAH

No

24 weeks plus extended timeline

545

University of Pennsylvania Still recruiting Anastrolzole (phase II, effect on TAPSE) PAH

Yes

12 weeks

18

Imperial College London Still recruiting Ferinject?(Iron injections) (phase II) IPAH

Yes

12 weeks

60

University of Heidelberg Still recruiting Exercise and Respiratory Therapy Connective Tissue related Pulmonary Hypertension

Yes

15 weeks

45

National Institute of Allergy and Infectious Diseases Still recruiting Rituximab (Phase II) Systemic sclerosis pulmonary hypertension

No

48 weeks

80

Medical University of Gratz Still recruiting Ambrisentan Porto-pulmonary Hypertnesion

No

24 weeks

24

Tufts Medical Centre Still recruiting Ambrisentan Porto-pulmonary Hypertnesion

No

24 weeks

30

University of Calafornia Still recruiting Iloprost Congenital Heart Disease PAH

Yes

12 weeks

16

 

 
  = SPVU is taking part.

 

 

b) Non-IPAH studies

 

Sponsor Trial Name Intervention Inclusion Criteria Other Disease Targeted Treatment Allowed Duration Target for Recruit- ment
Royal Brompton & Harefield NHS Foundation Trust B-PHIT Bosentan IPF or NSIP with pulmonary hypertension No 16 weeks + extension 48
The University of North Carolina Warfarin Sickle Cell Disease with pulmonary hypertension No 12 months 20
Capital Medical University Simvastatin CTEPH or PH secondary to congenital heart disease with PASP > 50mmHg
University Teaching Hospital Hall in Tirol BADDHY Bosentan Diastolic heart failure with pulmonary hypertension, PCWP > 15mmHg, NYHA II to III No 24 weeks 60
Hospital General Universitario Greorio Mara?on SIOVAC Sildenafil Previous heart valve intervention with pulmonary hypertension No 6 months 354
Bayer CHEST 2 Riociguat CTEPH 16 weeks + extension 270
University of Cincinnati BOSAPAH Bosentan Sarcoidosis with pulmonary hypertension, NYHA II to III No 48 weeks 60
University of Heidelberg Still recruiting The influence of respiratory and exercise therapy on 6 minute walk distance and quality of life CTEPH post endarte- rectomy

Yes

15 weeks

35

Italian Association of Hospital Pneumonologists Still recruiting SPHERIC-1 Sildenafil COPD with pulmonary hypertension

No

16 weeks

32

Italian Association of Hospital Pneumonologists Still recruiting TAPIT-1 Inhaled Treprostinil COPD with pulmonary hypertension

No

16 weeks

32

National Institutes of Health Clinical Centre Still recruiting Education plus an exercise programme PAH associated with ILD

Yes

10 weeks

175

University Hospital, Bordeaux Still recruiting DHEA-HTAP Dehydroepian-drosterone (DHEA) COPD with pulmonary hypertension

No

52 weeks

60

University of North Carolina Unknown SAPH Tadalafil (open label) Sarcoidosis associated PAH

No

20 weeks

20

Medical Research Network GmbH Active, not recruiting CTREPH Sub cutaneous treprostinil (Open label) Inoperable CTEPH

Yes

24 weeks

unknown

 

 
  = SPVU is taking part.

 

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