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Completed

NCT Number: NCT06778330

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

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

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Key information

Conditions

Heart Failure NYHA Class II

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin (DAPA)

Drug

Control group: receive dapagliflozin in addition to standard therapy

Sildenafil

Drug

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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