The Effect of Combination of Dapagliflozin and Sildenafil in Treatment of Heart Failure Patients with Secondary Pulmonary Hypertension

Not Applicable

Recruiting

• Conditions: Heart Failure NYHA Class II
• Interventions: Drug: Dapagliflozin (DAPA); Drug: Sildenafil

• Registration Number: NCT06778330
• Lead Sponsor: Fayoum University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	Dapagliflozin (DAPA)	-
test group	Sildenafil	-
control group	Dapagliflozin (DAPA)	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fayoum University; 🇪🇬 Fayoum, Egypt