Pulmonary Hypertension Associated With Connective Tissue DiseasePhase 4SIL-REACTNCT01889966
VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
A Phase 4 study testing Sildenafil in people with Pulmonary Hypertension Associated With Connective Tissue Disease, run by Kerckhoff Heart Center at 1 site in Germany.
Trial summary
Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary hypertension it is approved for treatment. The trial seeks to find out, whether the acute response to this treatment (= vasoreactivity testing) given intravenously is effective and allows prediction of therapy success during… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension Associated With Connective Tissue Disease
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Precapillary pulmonary hypertension associated with connective tissue disease
- resting mean pressure in the pulmonary artery of > 24 mmHg
- resting mean pulmonary capillary wedge pressure (PCWP) of < 16 mmHg
- age 18 to 80 years
- women of childbearing potential must have a negative pregnancy test (ß-HCG in urine) and must use effective methods of contraception
- women must not be breastfeeding
- ability to understand and sign the informed consent, correctly signed informed consent
Who cannot join
- pretreatment with Sildenafil
- contraindications for Sildenafil treatment:
- known intolerance to Sildenafil,
- optic neuropathy (NAION),
- known hereditary retina disease,
- need of nitrate therapy
Show all 9Show fewer
- advanced liver cirrhosis - CHILD C
- severely reduced renal function with GFR < 30 ml/min/1,73 m²
- stroke or myocardial infarction within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study)
Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary hypertension it is approved for treatment. The trial seeks to find out, whether the acute response to this treatment (= vasoreactivity testing) given intravenously is effective and allows prediction of therapy success during a following oral treatment.
- Being tested
- Sildenafil
- Keywords
- vasoreactivity testing, Sildenafil, precapillary pulmonary hypertension, connective tissue disease, mean pressure in the pulmonary artery 25 mmHg or more, mean pulmonary capillary wedge pressure below 16 mmHg
- Medical subject headings
- Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Revatio, CAS15 number 139755-83-2, EV Substance code SUB10517MIG
oral Sildenafil 3 x 20 mg for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | oral Sildenafil 20 mg three times a day for 90 days Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of Sildenafil I.V. for vasoreactivity testing
Right heart catheterisation with comprehensive hemodynamic measurements (pressures in RA, RV, PA, PCW position; cardiac index (CI) by thermodilution; oxygen saturation in the PA; the same under exercise conditions) is performed. In case of precapillary pulmonary hypertension, Sildenafil is given I.V. and acute tolerability, safety and efficacy on hemodynamic parameters are registrated. Successful vasoreactivity testing is defined by lowering the mean PA pressure by 10 mmHg or more, lowering it below 40 mmHg and maintaining / rising of the CI. Safety is mainly defined by lack of a substantial effect of the study drug on systemic blood pressure.
Measured: 1.5 hours
Secondary outcomes (1)
clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy
Complete hemodynamic and functional assessment after 90 days of oral Sildenafil therapy (same protocol as before except vasoreactivity testing). Hemodynamic parameters which characterize successful oral therapy are mainly mean PA-pressure (decrease), pulmonary vascular resistance (decrease) and cardiac index (increase) - at rest and exercise.
Functional improvement is further characterized by exercise capacity (cardiopulmonary exercise testing: improvement of V´O2 peak by ≥ 1 ml/min/kg), fall of NTproBNP, improvement of echocardiographic parameters of right ventricular function (TAPSE, S´, RV-FAC).
Evaluation, if positive initial vasoreactivity testing results in successful oral therapy as defined above.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Hypertension Associated With Connective Tissue DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerckhoff Heart Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dr. Andreas Rieth, Kerckhoff Heart Center
- Investigators
- Andreas J Rieth, MD, Principal investigator, Kerckhoff Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889966
- Sponsor's protocol ID
- WS2196851
- Acronym
- SIL-REACT
- Status last verified
- Apr 2015
- First submitted
- 9 Jun 2013
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rieth AJ, Richter MJ, Berkowitsch A, Frerix M, Tarner IH, Mitrovic V, Hamm CW. Intravenous sildenafil acutely improves hemodynamic response to exercise in patients with connective tissue disease. PLoS One. 2018 Sep 20;13(9):e0203947. doi: 10.1371/journal.pone.0203947. eCollection 2018.
PubMed 30235235
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study)
- ClinicalTrials.gov ID
- NCT01889966
- Acronym / sponsor ID
- SIL-REACT / WS2196851
- Keywords
- vasoreactivity testing, Sildenafil, precapillary pulmonary hypertension, connective tissue disease, mean pressure in the pulmonary artery 25 mmHg or more, mean pulmonary capillary wedge pressure below 16 mmHg
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kerckhoff Heart CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary hypertension it is approved for treatment. The trial seeks to find out, whether the acute response to this treatment (= vasoreactivity testing) given intravenously is effective and allows prediction of therapy success during a following oral treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: Sildenafiloral Sildenafil 20 mg three times a day for 90 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Precapillary pulmonary hypertension associated with connective tissue disease
- resting mean pressure in the pulmonary artery of > 24 mmHg
- resting mean pulmonary capillary wedge pressure (PCWP) of < 16 mmHg
- age 18 to 80 years
- women of childbearing potential must have a negative pregnancy test (ß-HCG in urine) and must use effective methods of contraception
Key exclusion criteria (9 listed)
- pretreatment with Sildenafil
- contraindications for Sildenafil treatment:
- advanced liver cirrhosis - CHILD C
- severely reduced renal function with GFR < 30 ml/min/1,73 m²
- stroke or myocardial infarction within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: Revatio, CAS15 number 139755-83-2, EV Substance code SUB10517MIGoral Sildenafil 3 x 20 mg for 90 days | Drug | Sildenafil |
Primary outcome
efficacy of Sildenafil I.V. for vasoreactivity testing
Time frame: 1.5 hours
Right heart catheterisation with comprehensive hemodynamic measurements (pressures in RA, RV, PA, PCW position; cardiac index (CI) by thermodilution; oxygen saturation in the PA; the same under exercise conditions) is performed. In case of precapillary pulmonary hypertension, Sildenafil is given I.V. and acute tolerability, safety and efficacy on hemodynamic parameters are registrated. Successful vasoreactivity testing is defined by lowering the mean PA pressure by 10 mmHg or more, lowering it below 40 mmHg and maintaining / rising of the CI. Safety is mainly defined by lack of a substantial effect of the study drug on systemic blood pressure.
1 secondary outcome
clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Derived from this study: PubMed 30235235Rieth AJ, Richter MJ, Berkowitsch A, Frerix M, Tarner IH, Mitrovic V, Hamm CW. Intravenous sildenafil acutely improves hemodynamic response to exercise in patients with connective tissue disease. PLoS One. 2018 Sep 20;13(9):e0203947. doi: 10.1371/journal.pone.0203947. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas J Rieth, MD principal investigator
Kerckhoff Heart Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil in people with Pulmonary Hypertension Associated With Connective Tissue Disease, run by Kerckhoff Heart Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of Sildenafil I.V. for vasoreactivity testing (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.