Heart Failure Patients Registry
- Conditions
- Heart Failure
- Registration Number
- NCT04709263
- Lead Sponsor
- AstraZeneca
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19990
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of men and women 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) Baseline At baseline of this study
Mean NT-proBNP level (or BNP) 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 Baseline At baseline of this study
Proportion of patients with different types of HF based on LVEF Baseline At baseline of this study
Proportion of patients with T2DM comorbid with different types of HF based on LVEF Baseline At baseline of this study
Mean HbA1c (for patients with T2DM) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF); 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) 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) 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 Baseline At baseline of this study
Mean age 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 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 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 Baseline 1. \<90 mm Hg;
2. ≥90 mm Hg;
At baseline of this studyProportion 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 Baseline 1. \<30 mg/g;
2. 30-300 mg/g;
3. \>300 mg/g;
At baseline of this studyProportion of patients with negative lifestyle factors 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 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) 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 Baseline At baseline of this study
Mean Na+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) 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 Baseline At baseline of this study
Mean BMI (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) Baseline At baseline of this study
Mean heart rate (HR) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF); Baseline At baseline of this study
Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with SBP 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 studyProportion of patients with HFrEF with implantable devices 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 studyProportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different functional classes of HF according to SHOKS level 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) 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) 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 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 studyMean hemoglobin level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) 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 Baseline 1. \<130 ms;
2. 130-150 ms;
3. \>150 ms;
At baseline of this studyProportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with cardiac surgery and endovascular procedures Baseline * Revascularisation with PCI;
* Revascularisation with CABG;
* Valvular surgery;
* Heart transplantation;
At baseline of this studyProportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving dual disease-modifying therapy 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 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 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 studyMean LVEF (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) Baseline At baseline of this study
Mean K+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) Baseline At baseline of this study
Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different rhythm Baseline 1. Sinus rhythm;
2. AF / AFl;
3. Pacemaker rhythm;
At baseline of this studyProportion of patients receiving different classes of drugs for treatment of HF 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 studyProportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving triple disease-modifying therapy Baseline At baseline of this study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇷🇺Yoshkar-Ola, Russian Federation