AzTrials
AzTrials

PASPPhase 1NCT07814482

Effect of Sacubitril-Valsartan on Estimated Pulmonary Artery Systolic Pressure in Patients With Heart Failure With Reduced Ejection Fraction Heart Failure

A Phase 1 study testing SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) in people with PASP, run by Aswan University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Evaluate effect of Sacubitril-Valsartan on estimated pulmonary artery systolic pressure in patient with reduced ejection fraction heart failure Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PASP
What is being tested?
SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteEgypt
Study dates
5 Jul 2025to 12 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged more than 18 years .
  • Diagnosed with HFrEF defined as those with an EF ≤40% .

Who cannot join

  • Patients < 18 years old
  • Patients with severe renal disease (i.e., estimated glomerular filtration rate according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation ≤30 mL/min/1.73 m2),
  • Patients with moderate-severe liver disease (i.e., a Child-Pugh score ≥7),
  • Patients with severe chronic obstructive pulmonary disease (i.e., Global Initiative for ---Chronic Obstructive Lung Disease class ≥3), History of acute pulmonary embolism
  • History of prior heart surgery with pericardial incision.
  • Pregnancy and lactation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of medicine- Aswan university

    Aswān

Other trials in Egypt

About this study

Official title: Effect of (Sacubitril-Valsartan) Drug on Estimated Pulmonary Artery Systolic Pressure

Evaluate effect of Sacubitril-Valsartan on estimated pulmonary artery systolic pressure in patient with reduced ejection fraction heart failure

Read the detailed description

Worldwide, the burden of heart failure has increased to an estimated 23 million people, and approximately 50% of cases are heart failure with reduced ejection fraction (HFrEF). Heart failure is a clinical syndrome characterized by dyspnea or exertional limitation due to impairment of ventricular filling or ejection of blood or both.

Heart failure with reduced ejection fraction HFrEF occurs when the left ventricular ejection fraction (LVEF) is 40% or less and is accompanied by progressive left ventricular dilatation and adverse cardiac remodeling. Assessment for heart failure begins with obtaining a medical history and physical examination. Also central to diagnosis are elevated natriuretic peptides above age- and context-specific thresholds and identification of left ventricular systolic dysfunction with LVEF of 40% or less as measured by echocardiography. Treatment strategies include the use of diuretics to relieve symptoms and application of an expanding armamentarium of disease-modifying drug and device therapies.

The Pulmonary hypertension definition has been changed recently to include mean Pulmonary artery pressure, 20 mm Hg, and Pulmonary vascular resistance, 2.0 WU, for distinguishing each of the hemodynamic Pulmonary hypertension subgroups: isolated precapillary, combined precapillary/postcapillary, and isolated postcapillary Pulmonary hypertension.

The goals of therapy of heart failure with reduced ejection fraction are to reduce morbidity (ie, reduce symptoms, improve health-related quality of life and functional status, and decrease the rate of hospitalization), and to reduce mortality.

Attempts to treat PH in HFpEF-PH have resulted in a succession of failures, despite approaching this problem from different pathobiological angles. The endothelin receptor antagonist bosentan, which is effective in pulmonary arterial hypertension, has failed in HFpEF-PH.3 The potent phosphodiesterase type 5 inhibitor sildenafil increases cyclic guanosine monophosphate (cGMP) levels, causing endogenous nitric oxide-mediated vasodilatation in both systemic and pulmonary vasculature. Despite the initial positive trial in the field reported by Guazzi et al., other attempts have failed to show a reduction in pulmonary artery pressure (PAP) or improvement in other haemodynamic parameters in HFpEF-PH. Increased cGMP levels by oral soluble guanylate cyclase stimulators also increase cGMP levels but do not affect PAP, pulmonary vascular resistance, or transpulmonary pressure gradient. Lastly, direct NO donors were examined in the INDIE-HFpEF (Inorganic Nitrite Delivery to Improve Exercise Capacity in Heart Failure with Preserved Ejection Fraction) trial but resulted in no benefit in terms of exercise capacity, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, New York Heart Association (NYHA) functional class, diastolic function, or N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

Management of heart failure with reduced ejection fraction HFrEF includes management of the cause of heart failure and associated conditions, monitoring, preventative care, care coordination, education and support for heart failure self-management (including lifestyle modification and daily monitoring), pharmacologic therapy, cardiac rehabilitation, palliative care, device therapy (including cardiac resynchronization therapy, implantable cardioverter defibrillator, and mechanical circulatory support [eg, LV assist device]) and cardiac transplantation .

The angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan (Sac/Val) is a particulate guanylyl cyclase activator that increases natriuretic peptides, which signal through cGMP and exert potent antimitogenic and vasodilatory effects.

Sacubitril/valsartan is the latest "disease-modifying drug" approved for the management of patients with heart failure with reduced ejection fraction (HFrEF) In addition to a reduction in the rate of mortality and hospitalization, both randomized clinical trials and real-life studies have shown that sacubitril/valsartan induced the "reverse remodeling" of the left ventricle (LV), with a reduction in the ventricular volumes, an increase in the ejection fraction (EF) [4,5], an improvement in the diastolic function and a reduction in the degree of functional mitral regurgitation.

In 2022 paper was published on the effect of Sacubitril/valsartan on pulmonary artery pressure in patients with heart failure with preserved function and shows these results Sacubitril/valsartan significantly reduced mean pulmonary artery pressure in patients with heart failure with preserved ejection fraction "HFpEF", independent of loop diuretic management, together with improvement in functional capacity, lung congestion, and quality of life. Sacubitril/valsartan may be a therapeutic alternative in HFpEF-PH .

In this study will be conducted to estimate the effect of (valsartan-sacubitril) on pulmonary artery systolic pressure in patient with HFrEF We will assume a research question which will be to what extent the use of (valsartan-sacubitril) does started from (50 mg bid to 200 mg bid) will cause reducing in pulmonary artery systolic pressure.

Conditions
PASP
Being tested
SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®)Drug

    sacubitril-Valsartan is ARNI that is one of the pillars of heart failure treatment, here we study its effect on estimated pulmonary artery systolic pressure and studying its effect on relieving elevated pulmonary pressure symptoms.

Study groups in NCT07814482
Study groupRoleWhat they receive
HFrEF patients on Sacubitril-Valsartan dose 24/26Active comparatorNumber of cases were 29 patients with reduced ejection fraction heart failure although being on 4 pillars of heart failure treatment " beta blockers, MRA, SGLT2 inhibitors and ACE inhibitor", replacement of ACEI with Sacubitril-Valsartan with dose 24mg/26mg was done with continuation on the same other anti-failure treatments
Receives: Drug: SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®)
HFrEF patients on Sacubitril-Valsartan dose 49/51Active comparatorNumber of cases were 30 patients with reduced ejection fraction heart failure although being on 4 pillars of heart failure treatment " beta blockers, MRA, SGLT2 inhibitors and ACE inhibitor", replacement of ACEI with Sacubitril-Valsartan with dose 49mg/51mg was done with continuation on the same other anti-failure treatments
Receives: Drug: SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of Sacubitril-Valsartan on ePASP on patients with HFrEF

    patients has been followed up by assessing echocardiography assessment of estimated PASP

    Measured: 1 year

Secondary outcomes (1)
  1. comparison of effect of doses of sacubitril valsartan on ePASP

    compare of the effect of different doses of Sacubitril Valsartan 24/26 and 46/51 on estimated pulmonary artery systolic pressur

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study start5 Jul 2025
  3. Primary completion5 Jul 2026
  4. Study completion12 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07814482
Sponsor's protocol ID
Sacubitril valsartan un PASP
Status last verified
Jul 2026
First submitted
12 Jul 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) in people with PASP, run by Aswan University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Sacubitril-Valsartan on ePASP on patients with HFrEF (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in