Pulmonary HypertensionPhase 2/3NCT03763045
Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
A Phase 2/3 study testing Sildenafil in people with Pulmonary Hypertension and Hemodialysis Complication, run by Ain Shams University at 1 site in Egypt.
Trial summary
Sildenafil is a phosphodiesterase inhibitor that can exert a nitric oxide-mediated vasodilation effect, so it's considered one of the preferred agents especially in hypoxia induced pulmonary hypertension, can achieve pulmonary vasodilation by enhancing sustained levels of cyclic guanosine monophosphate (cGMP) and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, Hemodialysis Complication
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2018to 28 Feb 2019
- Phase
- Phase 2/3
- 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
- Age from 18-80 years old.
- Patients on maintenance hemodialysis for more than six months receiving 3 sessions / week using bicarbonate dialysate with a low flux filter and heparin as anticoagulant.
- Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography
- Urea reduction ratio (URR) will be ≥ 60% for all patients.
- Dry weight will be targeted in each case to achieve edema-free state.
- Informed consent in accordance with the Declaration of Helsinki.
Who cannot join
- 1. Current treatment of pulmonary hypertension (prostacyclin analogues, endothelin receptor antagonists or phosphodiesterase inhibitors).
- 2-Heart diseases (congestive heart failure, ischemic heart disease, congenital heart disease).
- 3- Lung diseases (chronic obstructive pulmonary disease, pulmonary thromboemboli or tumor, interstitial lung diseases, sleep apnea, pulmonary fibrosis, Sarcoidosis).
- 4-Systemic diseases (scleroderma, systemic lupus erythematosus, portal hypertension).
- 5-Human immunodeficiency virus (HIV) infection. 6-History of hypersensitivity to sildenafil. 7-Treatment with any drugs that may interact with sildenafil (Erythromycin , Azoles, Saquinavir-CYP3A4 inhibitors- , Bosentan - CYP3A4 inducer-Nitrates ) 8- Uncontrolled hypertension 9- Anemia with hemoglobin level <10 g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
Sildenafil is a phosphodiesterase inhibitor that can exert a nitric oxide-mediated vasodilation effect, so it's considered one of the preferred agents especially in hypoxia induced pulmonary hypertension, can achieve pulmonary vasodilation by enhancing sustained levels of cyclic guanosine monophosphate (cGMP) and nitric oxide.
Despite the potential burden of pulmonary hypertension in hemodialysis patients, such agent like sildenafil has limited studies about optimum dose, safety and long term efficacy in End stage renal disease patients on hemodialysis with pulmonary hypertension
Read the detailed description
1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular function in hemodialysis patients with pulmonary hypertension.
- Primary outcome: ● Reduction in estimated Pulmonary Artery pressure value (ePAP) in mmHg via transthoracic Doppler Echocardiography.
- Secondary outcomes:
- Detection of safety of sildenafil in hemodialysis patients.
- Finding out sildenafil's optimum dose for hemodialysis patients with pulmonary hypertension.
- Conditions
- Pulmonary Hypertension, Hemodialysis Complication
- Being tested
- Sildenafil, Placebo
- 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
Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily
SildenafilDrug
Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily
PlaceboOther
Placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil 25 | Experimental | Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months. Receives: Drug: Sildenafil |
| Sildenafil 50 | Experimental | Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months. Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Twenty hemodialysis patients will receive a placebo tablet daily for 3 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Pulmonary Artery Pressure
Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)
Measured: 3 months
Secondary outcomes (1)
Transthoracic echocardiography
Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start2 Dec 2018
- Primary completion16 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sildenafil 25: Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months. Sildenafil 50: Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months. Placebo: Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ali Elbraky, Ain Shams University
- Investigators
- Tamer W Elsaid, MD, Study director, Associate Professor of Internal Medicine and Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763045
- Sponsor's protocol ID
- Med135
- Status last verified
- Jan 2019
- First submitted
- 7 Nov 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03763045
- Acronym / sponsor ID
- Med135
- Conditions
- Pulmonary Hypertension, Hemodialysis Complication
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 16 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 4 Dec 2018 (actual)
- 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 phosphodiesterase inhibitor that can exert a nitric oxide-mediated vasodilation effect, so it's considered one of the preferred agents especially in hypoxia induced pulmonary hypertension, can achieve pulmonary vasodilation by enhancing sustained levels of cyclic guanosine monophosphate (cGMP) and nitric oxide.
Despite the potential burden of pulmonary hypertension in hemodialysis patients, such agent like sildenafil has limited studies about optimum dose, safety and long term efficacy in End stage renal disease patients on hemodialysis with pulmonary hypertension
Detailed description
1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular function in hemodialysis patients with pulmonary hypertension.
- Primary outcome: ● Reduction in estimated Pulmonary Artery pressure value (ePAP) in mmHg via transthoracic Doppler Echocardiography.
- Secondary outcomes:
- Detection of safety of sildenafil in hemodialysis patients.
- Finding out sildenafil's optimum dose for hemodialysis patients with pulmonary hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Sildenafil 25: Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months. Sildenafil 50: Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months. Placebo: Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Sildenafil 25 | Experimental | Drug: SildenafilTwenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months. |
| Sildenafil 50 | Experimental | Drug: SildenafilTwenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months. |
| Placebo | Placebo comparator | Other: PlaceboTwenty hemodialysis patients will receive a placebo tablet daily for 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18-80 years old.
- Patients on maintenance hemodialysis for more than six months receiving 3 sessions / week using bicarbonate dialysate with a low flux filter and heparin as anticoagulant.
- Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography
- Urea reduction ratio (URR) will be ≥ 60% for all patients.
- Dry weight will be targeted in each case to achieve edema-free state.
Key exclusion criteria (5 listed)
- 1. Current treatment of pulmonary hypertension (prostacyclin analogues, endothelin receptor antagonists or phosphodiesterase inhibitors).
- 2-Heart diseases (congestive heart failure, ischemic heart disease, congenital heart disease).
- 3- Lung diseases (chronic obstructive pulmonary disease, pulmonary thromboemboli or tumor, interstitial lung diseases, sleep apnea, pulmonary fibrosis, Sarcoidosis).
- 4-Systemic diseases (scleroderma, systemic lupus erythematosus, portal hypertension).
- 5-Human immunodeficiency virus (HIV) infection. 6-History of hypersensitivity to sildenafil. 7-Treatment with any drugs that may interact with sildenafil (Erythromycin , Azoles, Saquinavir-CYP3A4 inhibitors- , Bosentan - CYP3A4 inducer-Nitrates ) 8- Uncontrolled hypertension 9- Anemia with hemoglobin level <10 g/dl
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 |
|---|---|---|
| SildenafilSildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily | Drug | Sildenafil 25 |
| SildenafilSildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily | Drug | Sildenafil 50 |
| PlaceboPlacebo tablet. | Other | Placebo |
Primary outcome
Decrease in Pulmonary Artery Pressure
Time frame: 3 months
Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)
1 secondary outcome
Transthoracic echocardiography
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Tamer W Elsaid, MD study director
Associate Professor of Internal Medicine and Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sildenafil in people with Pulmonary Hypertension and Hemodialysis Complication, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Jan 2019. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Decrease in Pulmonary Artery Pressure (time frame: 3 months). 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 9 Jan 2019.