Pulmonary HypertensionPhase 4NCT02378649
PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension
A Phase 4 study testing Sildenafil in people with Pulmonary Hypertension and Mitral Valve Surgery, run by Dr. Robert Klempfner Heart Rehabilitation Institute at 1 site in Israel.
Trial summary
A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in patients with pre-operative Significant Pulmonary Hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Mitral Valve Surgery
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 22
- Undergoing mitral valve surgery (either repair or replacement) with or without coronary revascularization, aortic valve replacement (AVR) or repair; or tricuspid valve surgery.
- Pre-operative pulmonary arterial systolic pressure >50 mm Hg as determined by resting echocardiography and post-operative sPAP > 45 mmHg as obtained from invasive hemodynamics measurements.
- Willing and able to give written informed consent prior to the procedure
Who cannot join
- Hypersensitivity to study drug
- Women of child-bearing potential
- Expected need to administer nitrates that are clinically indicated peri-operatively
- Post-operative hypotension (systolic blood pressure (BP) <80) or evidence of shock (postoperative evidence of any kinds of shock)
- Cardiac or systemic amyloidosis
- Active malignancy other than BCC (basal cell carcinoma)
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- Stable kidney dysfunction with Creatine clearence (CrCl) <30 mL/min during the screening period or hepatic failure other than mild
- Significant anemia (hemoglobin <8 mg/dl) preoperative.
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
- Any illness other than cardiac which might reduce life expectancy to less than 1 year from screening
Trial locations and contacts
1 site in 1 country.
Israel1 site
Cardiac Surgical Department, Leviev Heart Center
Ramat Gan, Tel Hashomer, 52621
About this study
Official title: A Randomized, Placebo Controlled, Single Center Clinical Trial for Evaluation of Efficacy and Safety of Sildenafil Administration in the Cardiac ICU Following Mitral Valve Surgery in Patients With Pulmonary Hypertension
A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in patients with pre-operative Significant Pulmonary Hypertension.
- Conditions
- Pulmonary Hypertension, Mitral Valve Surgery
- Being tested
- Sildenafil, Placebo
- Keywords
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Revatio \ Viagra
Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care
PlaceboDrug
Placebo comparator concomitant with best practice usual care
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | PDEI or placebo will be administered in the surgical ICU 4-6 hours after arriving from the Operative Room. The initial Dose will be 20mg X 3 NG and can be increase to 40mg X 3, it will be administered PO if the patient extubated.
PDEI or placebo will continue up to 8 days or discharge. Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | PDEI or placebo will be administered in the surgical ICU 4-6 hours after arriving from the Operative Room. The initial Dose will be 20mg X 3 NG and can be increase to 40mg X 3, it will be administered PO if the patient extubated.
PDEI or placebo will continue up to 8 days or discharge. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate if sildenafil results in greater reduction in average mean pulmonary artery pressure (mPAP) compared to placebo. (Percent change in mPAP pressure at 48 hours as compared to the immediate post operative averages.)
Percent change in mPAP pressure at 48 hours as compared to the immediate post operative averages. Pulmonary pressures will be obtained through invasive hemodynamic measurements
Measured: 48 hours
Secondary outcomes (4)
Time on mechanical ventilation
Measured: 96 hours
Total surgical intensive care time
Duration of Surgical ICU stay
Measured: participants will be followed for the duration of ICU stay, an expected average of 4 days
Change in functional capacity post operation (Change in NYHA functional class (optional 6MWT pre-discharge)
Change in NYHA functional class (optional 6 minute walk test [6MWT] pre-discharge)
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Study treatment related serious adverse events
Absence of serious adverse events related to study drug (shock, organ hypoperfusion, significant arrythmia and any other major event as defined by GCP guidelines) during hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Robert Klempfner Heart Rehabilitation Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378649
- Sponsor's protocol ID
- 1839-14-SMC
- Status last verified
- Jun 2018
- First submitted
- 5 Feb 2015
- Last updated
- 26 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Single Center Clinical Trial for Evaluation of Efficacy and Safety of Sildenafil Administration in the Cardiac ICU Following Mitral Valve Surgery in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02378649
- Acronym / sponsor ID
- 1839-14-SMC
- Conditions
- Pulmonary Hypertension, Mitral Valve Surgery
- Keywords
- Pulmonary Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Robert Klempfner Heart Rehabilitation InstituteOther government
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 4 Mar 2015 (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.
A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in patients with pre-operative Significant Pulmonary Hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SildenafilPDEI or placebo will be administered in the surgical ICU 4-6 hours after arriving from the Operative Room. The initial Dose will be 20mg X 3 NG and can be increase to 40mg X 3, it will be administered PO if the patient extubated. PDEI or placebo will continue up to 8 days or discharge. |
| Placebo | Placebo comparator | Drug: PlaceboPDEI or placebo will be administered in the surgical ICU 4-6 hours after arriving from the Operative Room. The initial Dose will be 20mg X 3 NG and can be increase to 40mg X 3, it will be administered PO if the patient extubated. PDEI or placebo will continue up to 8 days or discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 22
- Undergoing mitral valve surgery (either repair or replacement) with or without coronary revascularization, aortic valve replacement (AVR) or repair; or tricuspid valve surgery.
- Pre-operative pulmonary arterial systolic pressure >50 mm Hg as determined by resting echocardiography and post-operative sPAP > 45 mmHg as obtained from invasive hemodynamics measurements.
- Willing and able to give written informed consent prior to the procedure
Key exclusion criteria (10 listed)
- Hypersensitivity to study drug
- Women of child-bearing potential
- Expected need to administer nitrates that are clinically indicated peri-operatively
- Post-operative hypotension (systolic blood pressure (BP) <80) or evidence of shock (postoperative evidence of any kinds of shock)
- Cardiac or systemic amyloidosis
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 \ ViagraSildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care | Drug | Sildenafil |
| PlaceboPlacebo comparator concomitant with best practice usual care | Drug | Placebo |
Primary outcome
To evaluate if sildenafil results in greater reduction in average mean pulmonary artery pressure (mPAP) compared to placebo. (Percent change in mPAP pressure at 48 hours as compared to the immediate post operative averages.)
Time frame: 48 hours
Percent change in mPAP pressure at 48 hours as compared to the immediate post operative averages. Pulmonary pressures will be obtained through invasive hemodynamic measurements
4 secondary outcomes
Time on mechanical ventilation
Time frame: 96 hours
Total surgical intensive care time
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Change in functional capacity post operation (Change in NYHA functional class (optional 6MWT pre-discharge)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Study treatment related serious adverse events
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 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 26 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Mitral Valve Surgery, run by Dr. Robert Klempfner Heart Rehabilitation Institute at 1 site in Israel.
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 4 inclusion and 10 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 26 Jun 2018. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
To evaluate if sildenafil results in greater reduction in average mean pulmonary artery pressure (mPAP) compared to placebo. (Percent change in mPAP pressure at 48 hours as compared to the immediate post operative averages.) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2018.