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

NCT ID: NCT06778330

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2025-08-01

Brief Summary

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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

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Conditions

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Heart Failure NYHA Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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test group

Group Type ACTIVE_COMPARATOR

Dapagliflozin (DAPA)

Intervention Type DRUG

Control group: receive dapagliflozin in addition to standard therapy

Sildenafil

Intervention Type DRUG

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

control group

Group Type ACTIVE_COMPARATOR

Dapagliflozin (DAPA)

Intervention Type DRUG

Control group: receive dapagliflozin in addition to standard therapy

Interventions

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Dapagliflozin (DAPA)

Control group: receive dapagliflozin in addition to standard therapy

Intervention Type DRUG

Sildenafil

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Mohamed Abdallah

teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fayoum University

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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M 722

Identifier Type: -

Identifier Source: org_study_id

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