The Effect of Combination of Dapagliflozin and Sildenafil... | NCT06778330

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

NCT06778330

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Sep 3, 2025Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Heart Failure NYHA Class II

Interventions

Dapagliflozin (DAPA)
Sildenafil

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2025Actual

Primary Completion Date

Aug 1, 2025Actual

Completion Date

Aug 1, 2025Actual

First Submitted Date

Jan 9, 2025

First Submission Date that Met QC Criteria

Jan 14, 2025

First Posted Date

Jan 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2025

Last Update Posted Date

Sep 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
test group	Active Comparator		Drug: Dapagliflozin (DAPA) Drug: Sildenafil
control group	Active Comparator		Drug: Dapagliflozin (DAPA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin (DAPA)	Drug	Control group: receive dapagliflozin in addition to standard therapy	control group test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C529054	dapagliflozin
D000068677	Sildenafil Citrate

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

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