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Pulmonary REsistance modification under treatment with Sacubitil/valsartaN in paTients with HeartFailure with reduced ejection fraction
EU CTIS ID: 2024-517975-19-00
What this study is testing
Assessment of the effect of sacubitril/valsartan (S/V) therapy in comparsion to the group treated with ACE inhibitor - enalapril, on the parameters of right heart catheterization in terms of reduction of pulmonary artery pressure and changes in pulmonary circulation resistance in patients with developed pulmonary hypertension (PH) due to heart failure with reduced ejection fraction (HFrEF)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years of age who are able to complete and sign the informed consent form.
- HF patients in NYHA II-IV in whom right heart catheterization (RHC) reveals post-capillary pulmonary hypertension (defined on the basis of the 2022 ESC guidelines as PAPm >20 mmHg and PAWP > 15 mmHg); both isolated post-capillary PH (IpcPH) (defined on the basis of the 2022 ESC guidelines as PVR <= 2 WU) as well as combined post- and pre-capillary PH (CpcPH) (defined on the basis of the 2022 ESC guidelines as PVR > 2WU).
- Stable patients haemodynamics, which is defined as no change in diuretic use for at least 4 weeks prior to study entry
- Heart failure during optimal treatment with ACE-I / ARB, beta blocker, MRA, SGLT2i 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
You likely can't join if
- Current treatment with Sacubitryl/valsartan
- 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
See the full eligibility criteria
Who can join
- Age ≥18 years of age who are able to complete and sign the informed consent form.
- HF patients in NYHA II-IV in whom right heart catheterization (RHC) reveals post-capillary pulmonary hypertension (defined on the basis of the 2022 ESC guidelines as PAPm >20 mmHg and PAWP > 15 mmHg); both isolated post-capillary PH (IpcPH) (defined on the basis of the 2022 ESC guidelines as PVR <= 2 WU) as well as combined post- and pre-capillary PH (CpcPH) (defined on the basis of the 2022 ESC guidelines as PVR > 2WU).
- Stable patients haemodynamics, which is defined as no change in diuretic use for at least 4 weeks prior to study entry
- Heart failure during optimal treatment with ACE-I / ARB, beta blocker, MRA, SGLT2i 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
What rules you out
- Current treatment with Sacubitryl/valsartan
- 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 implantation in the last 3 months or planning for CRT implantation
- Life expectancy <6 months
- Severe renal failure, eGFR <30 ml / min / 1.73 m2 (calculated according to the MDRD formula)
- Serum potassium> 5.2 mEqL
- Severe heart Failure HF NYHA IV functional class and/or cardiogenic shock
- Liver failure or elevated liver transaminases (total bilirubin> 3 mg / dL and / or ALT and / or AST ≥3x ULN)
- A major surgery planned within 6 months of randomization
- Planned coronary angioplasty or pacemaker / ICD / 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 putting off oxygen therapy; - Severe asthma, - Morbid obesity (BMI> 40 kg / m2), - Significant lower limb atherosclerosis with intense intermittent claudication
- 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.
- Current treatment with sildenafil
- 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
- Patients ineligible or contraindicated for treatment with sacubitril/valsartan
- Patients with a history of angioedema associated with ACE I or ARB treatment
- Patients who have had a heart transplant or have had a circulatory support device
- Patient on the urgent list for heart transplant
- Isolated right heart failure secondary to lung disease
- Documented untreated significant ventricular arrhythmia with syncope within the previous 3 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.