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

NCT06778330 | Completed

• 1 other identifier: M 722
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure NYHA Class II

Outcome Measures

Primary Outcomes (2)

• change in ejection fraction

  Determine the influence of sildenafil as an add-on to dapagliflozin on Left ventricular ejection fraction using function using echocardiography

  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

  12 weeks after treatment

Study Arms (2)

test group

ACTIVE COMPARATOR

Drug: Dapagliflozin (DAPA); Drug: Sildenafil

control group

ACTIVE COMPARATOR

Drug: Dapagliflozin (DAPA)

Interventions

Dapagliflozin (DAPA) DRUG

Control group: receive dapagliflozin in addition to standard therapy

control group; test group

Sildenafil DRUG

Test group: receive combination therapy of dapagliflozin and a small dose of sildenafil(25mg/day) in addition to standard therapy

test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Interventions

dapagliflozin; Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 16, 2025
• Study Start: January 20, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

EG (1)