Heart FailurePhase 4PRESENT-HFNCT05487261
Pulmonary REsistance Modification Under Treatment With Sacubitril/valsartaN in paTients With Heart Failure With Reduced Ejection Fraction
A Phase 4 study testing Sacubitril-valsartan and Enalapril in people with Heart Failure, run by Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań at 5 sites in Poland.
Trial summary
MAIN OBJECTIVE. Demonstration that use of sacubitril/valsartan influences parameters of right heart catheterization, including pulmonary artery pressure, and provokes changes in pulmonary circulation resistance in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and post-capillary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sacubitril-valsartan and Enalapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 5 sitesPoland
- Study dates
- 13 Dec 2022to Nov 2025
- Phase
- Phase 4
- 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
- Age ≥18 years of age who are able to complete and sign the informed consent form.
- HF patients in NYHA functional class II-IV with a reduced left ventricular ejection fraction (LVEF) ≤40% -(HFrEF) (confirmed by an examination such as echocardiography or cardiac magnetic resonance within the last 6 months) in whom right heart catheterization (RHC) reveals post-capillary or mixed pulmonary hypertension (defined on the basis of the 2015 ESC (European Society of Cardiology) guidelines: mean pulmonary artery pressure (PAPm) ≥25 mmHg and pulmonary capillary wedge pressure (PCWP)>15mmHg) were found, both of the isolated extracapillary PH (Ipc-PH) (defined on the basis of the 2015 ESC guidelines: DPG < 7 mm Hg and / or PVR ≤ 3 WU) as well as complex extra-and pre-capillary PH (Cpc-PH) (defined on the basis of the 2015 ESC guidelines: DPG ≥ 7 mm Hg and / or PVR> 3 WU).
- Stable patients haemodynamics, which is defined as no change in diuretic use for at least 4 weeks prior to study entry.
- HF during optimal treatment with ACE-I (angiotensin converting enzyme) /ARB (angiotensin receptor blocker), beta blocker, MRA (Mineralocorticoid Receptor Antagonists), SGLT2-I except in cases where the above-mentioned treatment was contraindicated or not tolerated.
- Understanding and acceptance of the research assumptions and methods and signing the informed consent by the patient.
Who cannot join
- Current treatment with S/V.
- Cardiogenic shock.
- Current treatment with sildenafil.
- Patients ineligible or contraindicated for treatment with sacubitril-valsartan.
- Patients with a history of angioedema.
- Patients who have had a heart transplant or have had a circulatory support device.
Show all 33Show fewer
- Patient on the urgent list for heart transplant.
- Isolated right HF secondary to lung disease.
- Documented untreated significant ventricular arrhythmia with syncope within the previous 3 months.
- Symptomatic bradycardia or second or third degree atrioventricular block not protected by a pacemaker.
- Factors that prevent RHC testing (e.g. very serious condition of the patient that makes it impossible to lie down, cardiogenic shock, allergy to contrast agents, etc.).
- Pregnant or lactating women.
- Women of childbearing age, defined as the physiological possibility of becoming pregnant, unless using two methods of contraception.
- Acute coronary syndrome, including myocardial infarction (STEMI, NSTEMI), a condition with carotid revascularization or major cardiovascular surgery in the last 30 days.
- Stroke or transient cerebral ischemia (TIA) within the last 3 months.
- Previous CRT (Cardiac Resynchronization Therapy) implantation in the last 3 months or planning for CRT implantation.
- Life expectancy <6 months.
- Severe renal failure, eGFR (epidermal growth factor receptor) <30 ml / min / 1.73 m2(calculated according to the MDRD formula).
- Serum potassium> 5.2 mEq/L.
- Liver failure or elevated liver transaminases (total bilirubin> 3 mg / dL and/or ALT (Aspartate transaminase) and/or AST (Aspartate Aminotransferase) ≥3x ULN).
- A major surgery planned within 6 months of randomization.
- Planned coronary angioplasty or pacemaker / ICD (implantable cardioverter defibrillator) / CRT implantation within the next 6 months.
- Severe primary valve disease (NOT secondary mitral regurgitation) or obstructive hypertrophic cardiomyopathy.
- The presence of a malignant neoplasm of any organ system, ie clinical signs or no stable remission for at least 3 years after the end of the last treatment, with the exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical epithelial dysplasia.
- Diseases that significantly reduce physical performance:
- severe COPD (chronic obstructive pulmonary disease) putting off oxygen therapy,
- severe asthma,
- morbid obesity (BMI> 40 kg / m2),
- significant lower limb atherosclerosis with intense intermittent claudication.
- Uncontrolled hypertension (SBP> 170 mmHg and / or DBP> 100 mmHg).
- Symptomatic hypotension (SPB <90 mmHg)
- Any situation that may make it impossible to perform the research in accordance with the protocol or express written consent in the opinion of the researcher, including abuse of alcohol, drugs or other psychoactive substances.
- Participation in a study with a device or medicinal product within 3 months prior to randomization or 5 half-lives, whichever is longer, prior to the screening visit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites, 5 recruiting
- Not yet recruiting
Medical University of Bialystok Clinical Hospital
Bialystok, 15-276
Agnieszka Tycińska, Prof. MD
Agnieszka Tycińska, Prof. MD
- Not yet recruiting
University Clinical Centre in Gdańsk
Gdansk, 80-952
Marcin Gruchała, Prof. MD
Marcin Gruchała, Prof. MD
- Not yet recruiting
University Clinical Hospital in Opole
Opole, 45-401
Marek Gierlotka, Prof. MD
Marek Gierlotka, Prof. MD
- Recruiting
University Hospital in Poznan
Poznan, 61-848
Ewa Straburzyńska-Migaj, Prof. MD, ewa.straburzynska-migaj@skpp.edu.pl
Ewa Straburzyńska-Migaj, Prof. MD
- Not yet recruiting
Specialist Hospital in Zabrze
Zabrze, 41-800
Ewa Nowalany-Kozielska, Prof. MD
Ewa Nowalany-Kozielska, Prof. MD
About this study
Official title: Pulmonary REsistance Modification Under Treatment With Sacubitril/valsartaN in paTients With Heart Failure With Reduced Ejection Fraction - PRESENT HF Study
MAIN OBJECTIVE. Demonstration that use of sacubitril/valsartan influences parameters of right heart catheterization, including pulmonary artery pressure, and provokes changes in pulmonary circulation resistance in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and post-capillary pulmonary hypertension (PH): both isolated post-capillary (Ipc-PH) and combined post- and pre-capillary (Cpc-PH), which we predict could improve prognosis in this group of patients.
RESEARCH HYPOTHESIS. Sacubitril/valsartan used in patients with HFrEF accompanied by pulmonary hypertension due to HFrEF will reduce pulmonary artery pressure, pulmonary vascular resistance, and the incidence of secondary end-points as listed in the protocol.
STUDY OUTLINE. PRESENT-HF will show the effects of sacubitril/valsartan on pulmonary circulation pressure in patients with HFrEF and post-capillary pulmonary hypertension (PH): both isolated post-capillary (Ipc-PH) and combined post- and pre-capillary (Cpc-PH), which is expected to improve prognosis.
Read the detailed description
Non commercial, multicentre, randomised, double-blind, comparator-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention or comparator arm. Time of observation 13 months [1months active up titration phase + 12 months follow up].
- Conditions
- Heart Failure
- Being tested
- Sacubitril-valsartan, Enalapril, placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-valsartanDrug
level 1-24 / 26mg 2 times a day, level 2-49 / 51mg 2 times a day, level 3-97 / 103mg 2 times aday
EnalaprilDrug
level 1-2.5 mg twice a day, level 2-5 mg twice a day, level 3-10 mg twice a day
placeboDrug
placebo matching for 24 / 26mg, 49 / 51mg, 97 / 103mg 2 of sacubitril/valsartan
PlaceboDrug
placebo matching for 2.5 mg, 5 mg, 10 mg of enalapril
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril and valsartan combination | Experimental | Patient receive: 1 bottle with Sacubitril/Valsartan tablets and 2nd bottle with placebo to enalapril. Receives: Drug: Sacubitril-valsartan; Drug: Placebo |
| Enalapril | Active comparator | Patient receive: 1 bottle with placebo to Sacubitril/Valsartan and 2nd bottle with enalapril. Receives: Drug: Enalapril; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pulmonary artery pressure
change from baseline in mean pulmonary artery pressure (mPAP), measured invasively in Right Heart Catheterization (RHC)
Measured: 0-13 month
pulmonary vascular resistance
change from baseline in pulmonary vascular resistance (PVR), calculated from data measured invasively in Right Heart Catheterization (RHC)
Measured: 0-13 month
Secondary outcomes (14)
pulmonary wedge pressure
change from baseline in pulmonary wedge pressure (PWP), measured invasively in Right Heart Catheterization (RHC)
Measured: 0 -13 month
diastolic pressure gradient
change from baseline in the diastolic pressure gradient (DPG; where DPG = diastolic mPAP -mean PWP)
Measured: 0-13 month
6-minute walk test
change in the 6-minute walk test (6MWT) - analysis of changes from the baseline
Measured: 0-13 month
spiroergometric test (CPET, Cardio-Pulmonary Exercise Test)
evaluation of the parameters of the spiroergometric test - analysis of changes in relation to the baseline
Measured: 0-13 month
echocardiographic parameters
assessment of echocardiographic parameters - analysis of changes in echocardiographic parameters assessed in transthoracic echocardiographic examination (TTE)
Measured: 0-13 month
composite endpoint of MACCEs (major adverse cardiac and cerebrovascular events)
The incidence of the composite endpoint of MACCEs such as death from all causes, cardiac death, hospitalization due to worsening/ decompensation of heart failure (HF), stroke/ transient ischemic attack (TIA), acute coronary syndrome (ACS), the need for a heart transplant (HT), the need for a left ventricular assist device (LVAD) or biventricular(BVAD)
Measured: 0-13 month
hospitalization or an unplanned visit to the Emergency Department
hospitalization or an unplanned visit to the Emergency Department or an unplanned outpatient visit related to HF
Measured: 0-13 month
unplanned intravenous administration of diuretics and/or an unplanned hospitalization
the need for unplanned intravenous administration of diuretics and/or an unplanned hospitalization, outpatient visit due to the need to administer intravenous diuretics or requiring an increase in the dose of diuretics >50% from baseline
Measured: 0-13 month
quality of life measurements - Short Form 36 Health Survey (SF-36 questionnaire)
assessment of quality of life - SF-36 questionnaire - change from the baseline, the minimum and maximum values: 0-100, higher scores mean a less disability.
Measured: 0-13 month
quality of life measurements - Kansas City Cardiomyopathy Questionnaire (KCCQ)
assessment of quality of life - KCCQ, the minimum and maximum values: 0-100, higher scores mean higher quality of life.
Measured: 0-13 month
quality of life measurements - EuroQol-5 Dimensions-3 Level (EQ-5D-3L) questionnaire
assessment of quality of life - EQ-5D-3L questionnaire - change from the baseline, the minimum and maximum values: 0-100, higher scores mean higher quality of life.
Measured: 0-13 month
quality of life measurements - The World Health Organization Quality of Life (WHOQOL)
assessment of quality of life - WHOQOL - change from the baseline, the minimum and maximum values: 0-100, higher scores mean higher quality of life.
Measured: 0-13 month
the New York Heart Association functional classes
assessment of the New York Heart Association (NYHA) functional classes - change from the baseline, the minimum and maximum values: 1-4, higher scores mean a worse outcome.
Measured: 0-13 month
the World Health Organization functional classes
assessment of the World Health Organization (WHO) functional classes - change from the baseline, the minimum and maximum values: 1-4, higher scores mean a worse outcome.
Measured: 0-13 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start13 Dec 2022
- Primary completionFeb 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland, Medical University of Bialystok, University of Opole, Medical University of Gdansk, Medical University of Silesia
- Responsible party
- Sponsor
- Investigators
- Ewa Straburzyńska-Migaj, Prof. MD, Principal investigator, University Hospital in Poznan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487261
- Sponsor's protocol ID
- 2019/ABM/01/00078
- Acronym
- PRESENT-HF
- Status last verified
- Jun 2023
- First submitted
- 26 Jul 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary REsistance Modification Under Treatment With Sacubitril/valsartaN in paTients With Heart Failure With Reduced Ejection Fraction - PRESENT HF Study
- ClinicalTrials.gov ID
- NCT05487261
- Acronym / sponsor ID
- PRESENT-HF / 2019/ABM/01/00078
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in PoznańUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland, Medical University of Bialystok, University of Opole, Medical University of Gdansk, Medical University of Silesia
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MAIN OBJECTIVE. Demonstration that use of sacubitril/valsartan influences parameters of right heart catheterization, including pulmonary artery pressure, and provokes changes in pulmonary circulation resistance in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and post-capillary pulmonary hypertension (PH): both isolated post-capillary (Ipc-PH) and combined post- and pre-capillary (Cpc-PH), which we predict could improve prognosis in this group of patients.
RESEARCH HYPOTHESIS. Sacubitril/valsartan used in patients with HFrEF accompanied by pulmonary hypertension due to HFrEF will reduce pulmonary artery pressure, pulmonary vascular resistance, and the incidence of secondary end-points as listed in the protocol.
STUDY OUTLINE. PRESENT-HF will show the effects of sacubitril/valsartan on pulmonary circulation pressure in patients with HFrEF and post-capillary pulmonary hypertension (PH): both isolated post-capillary (Ipc-PH) and combined post- and pre-capillary (Cpc-PH), which is expected to improve prognosis.
Detailed description
Non commercial, multicentre, randomised, double-blind, comparator-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention or comparator arm. Time of observation 13 months [1months active up titration phase + 12 months follow up].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril and valsartan combination | Experimental | Drug: Sacubitril-valsartan, Drug: PlaceboPatient receive: 1 bottle with Sacubitril/Valsartan tablets and 2nd bottle with placebo to enalapril. |
| Enalapril | Active comparator | Drug: Enalapril, Drug: placeboPatient receive: 1 bottle with placebo to Sacubitril/Valsartan and 2nd bottle with enalapril. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years of age who are able to complete and sign the informed consent form.
- HF patients in NYHA functional class II-IV with a reduced left ventricular ejection fraction (LVEF) ≤40% -(HFrEF) (confirmed by an examination such as echocardiography or cardiac magnetic resonance within the last 6 months) in whom right heart catheterization (RHC) reveals post-capillary or mixed pulmonary hypertension (defined on the basis of the 2015 ESC (European Society of Cardiology) guidelines: mean pulmonary artery pressure (PAPm) ≥25 mmHg and pulmonary capillary wedge pressure (PCWP)>15mmHg) were found, both of the isolated extracapillary PH (Ipc-PH) (defined on the basis of the 2015 ESC guidelines: DPG < 7 mm Hg and / or PVR ≤ 3 WU) as well as complex extra-and pre-capillary PH (Cpc-PH) (defined on the basis of the 2015 ESC guidelines: DPG ≥ 7 mm Hg and / or PVR> 3 WU).
- Stable patients haemodynamics, which is defined as no change in diuretic use for at least 4 weeks prior to study entry.
- HF during optimal treatment with ACE-I (angiotensin converting enzyme) /ARB (angiotensin receptor blocker), beta blocker, MRA (Mineralocorticoid Receptor Antagonists), SGLT2-I except in cases where the above-mentioned treatment was contraindicated or not tolerated.
- Understanding and acceptance of the research assumptions and methods and signing the informed consent by the patient.
Key exclusion criteria (33 listed)
- Current treatment with S/V.
- Cardiogenic shock.
- Current treatment with sildenafil.
- Patients ineligible or contraindicated for treatment with sacubitril-valsartan.
- Patients with a history of angioedema.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril-valsartanlevel 1-24 / 26mg 2 times a day, level 2-49 / 51mg 2 times a day, level 3-97 / 103mg 2 times aday | Drug | Sacubitril and valsartan combination |
| Enalaprillevel 1-2.5 mg twice a day, level 2-5 mg twice a day, level 3-10 mg twice a day | Drug | Enalapril |
| placeboplacebo matching for 24 / 26mg, 49 / 51mg, 97 / 103mg 2 of sacubitril/valsartan | Drug | Enalapril |
| Placeboplacebo matching for 2.5 mg, 5 mg, 10 mg of enalapril | Drug | Sacubitril and valsartan combination |
Primary outcome
mean pulmonary artery pressure
Time frame: 0-13 month
change from baseline in mean pulmonary artery pressure (mPAP), measured invasively in Right Heart Catheterization (RHC)
pulmonary vascular resistance
Time frame: 0-13 month
change from baseline in pulmonary vascular resistance (PVR), calculated from data measured invasively in Right Heart Catheterization (RHC)
14 secondary outcomes
pulmonary wedge pressure
Time frame: 0 -13 month
diastolic pressure gradient
Time frame: 0-13 month
6-minute walk test
Time frame: 0-13 month
spiroergometric test (CPET, Cardio-Pulmonary Exercise Test)
Time frame: 0-13 month
echocardiographic parameters
Time frame: 0-13 month
composite endpoint of MACCEs (major adverse cardiac and cerebrovascular events)
Time frame: 0-13 month
hospitalization or an unplanned visit to the Emergency Department
Time frame: 0-13 month
unplanned intravenous administration of diuretics and/or an unplanned hospitalization
Time frame: 0-13 month
quality of life measurements - Short Form 36 Health Survey (SF-36 questionnaire)
Time frame: 0-13 month
quality of life measurements - Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 0-13 month
quality of life measurements - EuroQol-5 Dimensions-3 Level (EQ-5D-3L) questionnaire
Time frame: 0-13 month
quality of life measurements - The World Health Organization Quality of Life (WHOQOL)
Time frame: 0-13 month
the New York Heart Association functional classes
Time frame: 0-13 month
the World Health Organization functional classes
Time frame: 0-13 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Straburzyńska-Migaj, Prof. MD principal investigator
University Hospital in Poznan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril-valsartan and Enalapril in people with Heart Failure, run by Clinical Hospital Heliodor Swiecicki of the Medical University of Karol Marcinkowski in Poznań at 5 sites in Poland.
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 5 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Kałużna-Oleksy, MD, PhD (502 896 932 ext. 0048, marta.kaluzna@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean pulmonary artery pressure (time frame: 0-13 month). The study lists 2 primary outcomes in all. 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 18 Jun 2023.