Heart Failure NYHA Class IINCT06778330
The Effect of Combination of Dapagliflozin and Sildenafil in Treatment of Heart Failure Patients With Secondary Pulmonary Hypertension
A study testing Dapagliflozin (DAPA) and Sildenafil in people with Heart Failure NYHA Class II, run by Fayoum University at 1 site in Egypt.
Trial summary
This study aims to determine the efficacy of sildenafil (improve PAH) as an add-on therapy to dapagliflozin in the treatment of heart failure patients with secondary pulmonary arterial hypertension and compare the result with monotherapy dapagliflozin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class II
- What is being tested?
- Dapagliflozin (DAPA) and Sildenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to 1 Aug 2025
- Phase
- Interventional
- 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
- patients with established heart failure with secondary pulmonary hypertension seen by a primary care provider to diagnose a heart disease, the patient's symptoms which may experience:
- Dizziness or fainting
- Heart palpitations, which may feel like your heart fluttering or skipping beats
- Shortness of breath
Who cannot join
- Patients with a history of severe allergic reactions or hypersensitivity to sildenafil, dapagliflozin, or related medications.
- Individuals with contraindications to the use of sildenafil or dapagliflozin.
- Patients with pulmonary arterial hypertension (PAH) due to conditions other than heart failure (e.g., idiopathic PAH).
- severe hepatic impairment
- aged less than 18 years.
- valvular heart disease .
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- Patients with a known or suspected history of non-compliance with medical treatment or inability to adhere to study procedures.
- life expectancy of less than 6 months .
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the efficacy of sildenafil (improve PAH) as an add-on therapy to dapagliflozin in the treatment of heart failure patients with secondary pulmonary arterial hypertension and compare the result with monotherapy dapagliflozin
- Conditions
- Heart Failure NYHA Class II
- Being tested
- Dapagliflozin (DAPA), Sildenafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (DAPA)Drug
Control group: receive dapagliflozin in addition to standard therapy
SildenafilDrug
Test group: receive combination therapy of dapagliflozin and a small dose of sildenafil(25mg/day) in addition to standard therapy
| Study group | Role | What they receive |
|---|---|---|
| test group | Active comparator | Not described Receives: Drug: Dapagliflozin (DAPA); Drug: Sildenafil |
| control group | Active comparator | Not described Receives: Drug: Dapagliflozin (DAPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ejection fraction
Determine the influence of sildenafil as an add-on to dapagliflozin on Left ventricular ejection fraction using function using echocardiography
Measured: 12 weeks after treatment
change in systolic pulmonary artery pressure
Determine the influence of sildenafil as an add-on to dapagliflozin on systolic pulmonary artery pressure using echocardiography
- Evaluate the impact of sildenafil as an adjunct therapy to dapagliflozin on pulmonary arterial hypertension
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start20 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- More trials run by Fayoum 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Abdallah, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778330
- Sponsor's protocol ID
- M 722
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination of Dapagliflozin and Sildenafil in Treatment of Heart Failure Patients With Secondary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06778330
- Acronym / sponsor ID
- M 722
- Conditions
- Heart Failure NYHA Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 16 Jan 2025 (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.
This study aims to determine the efficacy of sildenafil (improve PAH) as an add-on therapy to dapagliflozin in the treatment of heart failure patients with secondary pulmonary arterial hypertension and compare the result with monotherapy dapagliflozin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Active comparator | Drug: Dapagliflozin (DAPA), Drug: Sildenafil |
| control group | Active comparator | Drug: Dapagliflozin (DAPA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with established heart failure with secondary pulmonary hypertension seen by a primary care provider to diagnose a heart disease, the patient's symptoms which may experience:
- Dizziness or fainting
- Heart palpitations, which may feel like your heart fluttering or skipping beats
- Shortness of breath
Key exclusion criteria (9 listed)
- Patients with a history of severe allergic reactions or hypersensitivity to sildenafil, dapagliflozin, or related medications.
- Individuals with contraindications to the use of sildenafil or dapagliflozin.
- Patients with pulmonary arterial hypertension (PAH) due to conditions other than heart failure (e.g., idiopathic PAH).
- severe hepatic impairment
- aged less than 18 years.
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 |
|---|---|---|
| Dapagliflozin (DAPA)Control group: receive dapagliflozin in addition to standard therapy | Drug | control group, test group |
| SildenafilTest group: receive combination therapy of dapagliflozin and a small dose of sildenafil(25mg/day) in addition to standard therapy | Drug | test group |
Primary outcome
change in ejection fraction
Time frame: 12 weeks after treatment
Determine the influence of sildenafil as an add-on to dapagliflozin on Left ventricular ejection fraction using function using echocardiography
change in systolic pulmonary artery pressure
Time frame: 12 weeks after treatment
Determine the influence of sildenafil as an add-on to dapagliflozin on systolic pulmonary artery pressure using echocardiography * Evaluate the impact of sildenafil as an adjunct therapy to dapagliflozin on pulmonary arterial hypertension
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 3 Sep 2025.
- 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.
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 study testing Dapagliflozin (DAPA) and Sildenafil in people with Heart Failure NYHA Class II, run by Fayoum 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 4 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 3 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
change in ejection fraction (time frame: 12 weeks after treatment). The study lists 2 primary outcomes in all. 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 3 Sep 2025.