Heart Failure NYHA Class II
Conditions
Brief 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
Interventions
Control group: receive dapagliflozin in addition to standard therapy
DRUGSildenafil
Test group: receive combination therapy of dapagliflozin and a small dose of sildenafil(25mg/day) in addition to standard therapy
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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 . * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in ejection fraction | 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 | 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 |
Countries
Egypt
Outcome results
None listed