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临床试验/NCT04709263
NCT04709263已完成不适用

Heart Failure Patients Registry A Prospective Observational Multicenter Registry of Patients With Chronic Heart Failure in the Population of the Russian Federation (PRIORITY-HF)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 19,990 人开始时间: 2020年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
19,990
试验地点
1
主要终点
Mean age

研究概览

简要总结

This study is a multicenter non-interventional observational prospective registry. This non-interventional study (NIS) does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation. The study will include only those patients who sign the informed consent form (ICF) after explanation of the study objectives and methods by the study physician.

Planned study population consists of 20 000 adult outpatients with HF. All patients with HF who signed an ICF will be included to this study. Planned number of study sites is 150 outpatient centers in about 50 regions (in order to describe characteristics of outpatients with HF in different regions in the most comprehensive way).

Expected inclusion period duration - 24 months OR reaching 20 000 patients, if this takes less than 24 months. Planned follow-up period duration for 1 patient is about 52 weeks (12 months), which includes 3 visits (visit 1 - inclusion; visit 2 - approximately 6 months after inclusion; visit 3 - approximately 12 months after inclusion)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years at the time of inclusion;
  • Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
  • Documented diagnosis of HF (according to Clinical Guidelines "Chronic Heart Failure", 2020, approved by MoH of RF) with typical symptoms/signs of HF consistent with I-IV functional classes of HF according to NYHA classification.

排除标准

  • The absence of signed ICF;
  • The participation in any randomised controlled trial within 3 months before the inclusion in this study or during the participation in this study.

结局指标

主要结局

Mean age

时间窗: Baseline

At baseline of this study

Proportion of men and women

时间窗: Baseline

At baseline of this study

Mean duration of comorbidities listed in previous paragraph (p. 5) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

At baseline of this study

Mean NT-proBNP level (or BNP)

时间窗: Baseline

NT-proBNP is measured in pg / mL. At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with vaccination

时间窗: Baseline

At baseline of this study

Proportion of patients with different types of HF based on LVEF

时间窗: Baseline

At baseline of this study

Proportion of patients with T2DM comorbid with different types of HF based on LVEF

时间窗: Baseline

At baseline of this study

Mean HbA1c (for patients with T2DM) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample, in subgroups of patients with HFrEF, HFmEF and HFpEF, in sub-subgroups of patients with CKD and without CKD) with concomitant hyperkalemia (K+ level >5,5 mmol/L)

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample, in subgroups of patients with HFrEF, HFmEF and HFpEF, in sub-subgroups of patients with CKD and without CKD) with concomitant hypokalemia (K+ level <3,5 mmol/L)

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different chronic comorbidities

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with a history of HF comorbidities and conditions of special interest

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different BMI levels

时间窗: Baseline

The BMI will be calculated using a formula based on the patient's anthropometric data collected at visit q (height measured in meters and body weight measured in kilograms). BMI (kg / m2) is calculated using the formula: BMI = weight (kg) / (height2 (m2))

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with DBP

时间窗: Baseline

1. \<90 mm Hg; 2. ≥90 mm Hg; At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with CKD and different levels of albumin-to-creatinine ratio in a spot urine sample

时间窗: Baseline

1. \<30 mg/g; 2. 30-300 mg/g; 3. \>300 mg/g; At baseline of this study

Proportion of patients with negative lifestyle factors

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different etiology of CHF

时间窗: Baseline

At baseline of this study

Proportions of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different levels of HbA1c (for patients with T2DM)

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different functional classes of CHF according to NYHA classification based on patient symptoms of HF

时间窗: Baseline

At baseline of this study

Mean Na+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with history of COVID-19

时间窗: Baseline

At baseline of this study

Mean BMI (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

At baseline of this study

Mean heart rate (HR) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with SBP

时间窗: Baseline

1. \<90 mm Hg; 2. 90-99 mm Hg; 3. 100-109 mm Hg; 4. 110-119 mm Hg; 5. 120-139 mm Hg; 6. 140-159 mm Hg; 7. ≥160 mm Hg; At baseline of this study

Proportion of patients with HFrEF with implantable devices

时间窗: Baseline

* Implantable cardioverter-defibrillator (ICD) (recommended; implanted); * Cardiac resynchronisation therapy (CRT) (recommended; implanted); * CRT with defibrillation (CRT-D) (recommended; implanted); * Left ventricular assist device (LVAD); At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different functional classes of HF according to SHOKS level

时间窗: Baseline

1. Functional Class I - ≤3 points; 2. Functional Class II - from 4 to 6 points; 3. Functional Class III - from 7 to 9 points; 4. Functional Class IV - more than 9 points; At baseline of this study.

Mean SBP (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

SBP - Systolic blood pressure. At baseline of this study.

Mean Diastolic blood pressure (DBP) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with concomitant CKD of different stages

时间窗: Baseline

eGFR = 141 x min(SCr/κ, 1)\^α x max(SCr/κ, 1)\^-1.209 x 0.993\^Age x 1.018 \[if female\] x 1.159 \[if Black\], where eGFR (estimated glomerular filtration rate) = mL/min/1.73 m\^2, SCr (standardized serum creatinine) = mg/dL, κ = 0.7 (females) or 0.9 (males), α = -0.329 (females) or -0.411 (males), min = indicates the minimum of SCr/κ or 1, max = indicates the maximum of SCr/κ or 1, age = years. At baseline of this study

Mean hemoglobin level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different QRS duration

时间窗: Baseline

1. \<130 ms; 2. 130-150 ms; 3. \>150 ms; At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with cardiac surgery and endovascular procedures

时间窗: Baseline

* Revascularisation with PCI; * Revascularisation with CABG; * Valvular surgery; * Heart transplantation; At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving dual disease-modifying therapy

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving quadruple disease-modifying therapy

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with CHF receiving different classes of glucose lowering drugs and their combinations for T2DM treatment

时间窗: Baseline

* Modification of diet and lifestyle only; * Metformin; * Sulfonylureas; * Inhibitors of dipeptidyl peptidase-4 (iDPP4); * iSGLT2; * Glucagon-like peptide-1 receptor agonists (GLP1 RA); * Acarbose; * Insulins. At baseline of this study

Mean LVEF (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

At baseline of this study

Mean K+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)

时间窗: Baseline

At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different rhythm

时间窗: Baseline

1. Sinus rhythm; 2. AF / AFl; 3. Pacemaker rhythm; At baseline of this study

Proportion of patients receiving different classes of drugs for treatment of HF

时间窗: Baseline

* ACE inhibitors (duration, dosage, proportion of patients receiving: \<50% of target dose, 50-100% of target dose, ≥100% of target dose); * B-blockers (duration, dosage, proportion of patients receiving: \<50% of target dose, 50-100% of target dose, ≥100% of target dose); * ARBs (duration, dosage, proportion of patients receiving: \<50% of target dose, 50 100% of target dose, ≥100% of target dose); * MRAs (duration, dosage, proportion of patients receiving: \<50% of target dose, 50 100% of target dose, ≥100% of target dose); * ARNI (duration, dosage, proportion of patients receiving: \<50% of target dose, 50 100% of target dose, ≥100% of target dose); At baseline of this study

Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving triple disease-modifying therapy

时间窗: Baseline

At baseline of this study

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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