2024-517975-19-00招募中4 期
Pulmonary REsistance modification under treatment with Sacubitil/valsartaN in paTients with HeartFailure with reduced ejection fraction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 7
- 主要终点
- Change from baseline in mean pulmonary artery pressure (mPAP).
研究概览
简要总结
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)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in mean pulmonary artery pressure (mPAP).
Change from baseline in mean pulmonary artery pressure (mPAP).
Change from baseline in pulmonary vascular resistance (PVR).
Change from baseline in pulmonary vascular resistance (PVR).
次要结局
- Change from baseline in pulmonary wedge pressure (PWP).
- Change from baseline in the diastolic pressure gradient (DPG; where DPG = diastolic mPAP – mean PWP ).
- Change in the 6-minute walk test (6MWT) - analysis of changes from the baseline.
- Evaluation of the parameters of the spiroergometric test (CPET, Cardio-Pulmonary Exercise Test) analysis of changes in relation to the baseline.
- Assessment of echocardiographic parameters - analysis of changes in relation to the baseline
- The incidence of the composite endpoint of MACCEs such as death from all causes, cardiac death, hospitalization due to worsening / decompensation of 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 , an unplanned hospitalization or an outpatient visit due to the need to administer intravenous diuretics or requiring an increase in the dose of diuretics >50% base
- Hospitalization or an unplanned visit to the Emergency Department or an unplanned outpatient visit related to HF
- The need for unplanned intravenous administration of diuretics.
- Assessment of quality of life will be conducted between 0-52 weeks (QoL indicators - Kansas City Cardiomyopathy Questionnaire (KCCQ-12), WHO (WHOQOL-BREF), SF-36 questionnaire, EQ-5D-3L questionnaire) - change from the baseline
- Assessment of the New York Heart Association (NYHA) and the World Health Organization (WHO) functional classes - change from the baseline
研究者
Lead Principal Investigator
Scientific
Uniwersytecki Szpital Kliniczny W Poznaniu
研究点 (7)
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