EUCTR2005-004972-20-GR进行中（未招募）不适用
A Phase II Study to assess the hemodynamic effects of ISTAROXIME, a novel lusinotropic agent, in patients hospitalized with worsening heart failure and a reduced left ventricular systolic function. - The Horizon-HF Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be enrolled in the study during the first 48 hours of hospitalisation (screening period).
- •Screening period inclusion criteria:
- •- Capability of understanding the nature of the trial and willingness to participate as documented by signing the written informed consent form.
- •- Male or female patients aged between 18 and 85 years.
- •- Negative pregnancy test at screening, for women of childbearing potential only.
- •- Body weight less than or equal to 100 kg.
- •- Blood pressure not more than SAP150 or DAP 90 mmHg.
- •- Heart rate in the range of 60-110 bpm.
- •- Adequate Echo window available.
- •- Hospital admission to a monitored bed with a primary diagnosis of worsening of heart failure and Left Ventricular Ejection Fraction less than or equal to 35% documented by 2D-Echocardiogram, or radionuclide angiography or LV angiogram within 6 months prior to screening or at hospitalisation.
- •- the clinical condition of the patient is stailized within 48 hours form hospitalization and does not require continuous iv drug treatments
- •- no need for additional new oral treatments or any intravenous treatment administration over the following 8 hours is foreseen
- •- a balloon-flotation pulmonary artery catherter insertion is feasible
- •Randomisation period inclusion criteria:
- •- Any residual sign of heart failure (e.g.: Jugular Venous Distension, and or Rales and /or Peripheral Oedema) associated with a Pulmonary Capillary Wedge Pressure (PCWP) greater than or equal to 20 mmHG.
- •- The last three consecutive determinations of PCWP, obtained during the stabilisation period, have to be in a maximum range of variability 0f 10%.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Ongoing treatment with oral or intravenous inotropes and/or inodilators (amrinone, digoxin, dopamine, dobutamine, enoximone, levosimendan, milrinone). Patient treated with digoxin within the last week, can be randomised if the plasma concentration of digoxin are tested before randomisation and its value will be less than 0.5 ng/ml.
- •- Intermittent inotropes administration within 2 weeks.
- •- Symptoms of Heart Failure at randomization e.g.: dyspnoea
- •- Systolic blood pressure < 90 mmHg.
- •- Atrial fibrillation within 2 weeks.
- •- Left Ventricular Bundle Branch Block
- •- Cardiogenic shock.
- •- Mechanical ventilation.
- •- Creatinine level > 3.0 mg/dl or requiring dialysis treatment.
- •- Left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy, uncorrected thyroid disease, known acute myocarditis, known amyloid cardiomyopathy.
- •- Artificial heart valve.
- •- Electrical device implanted (ICD, CRT)
- •- Evidence of acute coronary syndrome within 3 months.
- •- History of stroke or transient ischemic attack in the 6 months prior to screening.
- •- History of sustained ventricular tachycardia.
- •- Coronary by-pass grafting or PTCA within the last 30 days
- •- INR > 1.5.
- •- Status post successful cardiac resuscitation.
- •- Serum K < 3.5 mEq/l or > 5.3 mEq/l just prior to treatment.
- •- ALT, AST > 3 times the upper normal limit just prior to treatment.
- •- Hemoglobin < 10 g/dl (either gender) just prior to treatment.
- •- Other clinically significant laboratory or medical conditions, which in the opinion of the Investigator make the patient unsuitable for evaluation in the study.
- •- Anticipated survival of less than 2 months for concomitant diseases.
研究者
相似试验
招募中
不适用
Clinical study to evaluate hemodynamic change in exercise test with or without protective maskKCT0005235Chungbuk National University Hospital90
进行中（未招募）
不适用
Clinical investigation into efficacy, hemodynamics and tolerability of simvastatin vs placebo in patients with pulmonary arterial hypertension(Shorttitle: SIPHT)Double-blind, randomized, prospective Phase III-b study for 6 months with adjusting doses of simvastatin (40/80 mg daily) or placebo followed by an open-label period with a final dose of simvastatin 80 mg daily for another 6 months - SIPHTModified NYHA class II or III patients with Pulmonary Hypertension (PH), ICD: 416.9MedDRA version: 8.1Level: LLTClassification code 10020787Term: Hypertension pulmonaryEUCTR2005-004863-41-DEDept. of Internal Medicine II, University Hospital Giessen40
尚未招募
3 期
Assessment of variation in blood pressure and pulse rate when fomentation done with steam chamber.CTRI/2022/07/043996Sri Sri College of Ayurvedic Science and Research Hospital
已完成
不适用
Clinical investigation into efficacy, haemodynamics and tolerability of simvastatin versus placebo in patients with pulmonary arterial hypertensioPulmonary hypertensionCirculatory SystemOther pulmonary heart diseasesISRCTN27178415niversity Hospital Giessen (Germany)40
尚未招募
不适用
Evaluation of all haemodnamic changes occuring during total knee arthroplasty under regional aanesthesiaCTRI/2020/05/025111Department of anaesthesia