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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)
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| Measure | Description | Time Frame |
|---|---|---|
| Mean age | At baseline of this study | Baseline |
| Proportion of men and women | At baseline of this study | Baseline |
| Proportion of patients with negative lifestyle factors | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different etiology of CHF | At baseline of this study | Baseline |
| 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 | At baseline of this study | Baseline |
| Mean duration of comorbidities listed in previous paragraph (p. 5) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different chronic comorbidities | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with history of COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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This non-interventional multicenter observational study will include 20,000 adult outpatients with HF who are monitored and treated by cardiologists or internal medicine specialists. In the study, patients will be followed up for about 12 months after being included in approximately 150 clinical centers in Russia. This NIS does not imply any intervention in routine clinical practice, including choice of treatment modality or special methods of investigation. It is planned to include all patients with CHF, who gave their informed consent to participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Akhtubinsk | Astrakhan Oblast | Russia | |||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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At baseline of this study |
| Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with vaccination | At baseline of this study | Baseline |
| Proportion of patients with different types of HF based on LVEF | At baseline of this study | Baseline |
| Proportion of patients with T2DM comorbid with different types of HF based on LVEF | At baseline of this study | Baseline |
| Mean HbA1c (for patients with T2DM) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF); | At baseline of this study | Baseline |
| Proportions of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different levels of HbA1c (for patients with T2DM) | At baseline of this study | Baseline |
| Mean BMI (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different BMI levels | 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)) | Baseline |
| 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 | At baseline of this study | Baseline |
| Mean NT-proBNP level (or BNP) | NT-proBNP is measured in pg / mL. At baseline of this study | Baseline |
| Mean heart rate (HR) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF); | At baseline of this study | Baseline |
| 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 |
At baseline of this study. | Baseline |
| Mean SBP (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | SBP - Systolic blood pressure. At baseline of this study. | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with SBP |
At baseline of this study | Baseline |
| Mean Diastolic blood pressure (DBP) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with DBP |
At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with concomitant CKD of different stages | 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 | Baseline |
| 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 |
At baseline of this study | Baseline |
| 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) | At baseline of this study | Baseline |
| 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) | At baseline of this study | Baseline |
| Mean LVEF (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | At baseline of this study | Baseline |
| Mean K+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | At baseline of this study | Baseline |
| Mean Na+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | At baseline of this study | Baseline |
| Mean hemoglobin level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different rhythm |
At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different QRS duration |
At baseline of this study | Baseline |
| Proportion of patients receiving different classes of drugs for treatment of HF |
At baseline of this study | Baseline |
| Proportion of patients with HFrEF with implantable devices |
At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with cardiac surgery and endovascular procedures |
At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving dual disease-modifying therapy | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving triple disease-modifying therapy | At baseline of this study | Baseline |
| Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving quadruple disease-modifying therapy | At baseline of this study | Baseline |
| 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 |
At baseline of this study | Baseline |
| Stary Oskol |
| Belgorod Oblast |
| Russia |
| Research Site | Gurievsk | Kaliningrad Oblast | Russia |
| Research Site | Rodniki Settlement | Kaliningrad Oblast | Russia |
| Research Site | Korolyov | Moscow Oblast | Russia |
| Research Site | Lyubertsy | Moscow Oblast | Russia |
| Research Site | Pushchino | Moscow Oblast | Russia |
| Research Site | Bor | Nizhniy Novgorod Region | Russia |
| Research Site | Beslan | North Ossetia-Alania | Russia |
| Research Site | Zubova Polyana Settlement | Respublika Mordoviya | Russia |
| Research Site | Aramil | Sverdlovsk Oblast | Russia |
| Research Site | Arkhangelsk | Russia |
| Research Site | Astrakhan | Russia |
| Research Site | Barnaul | Russia |
| Research Site | Bataysk | Russia |
| Research Site | Belgorod | Russia |
| Research Site | Bryansk | Russia |
| Research Site | Cheboksary | Russia |
| Research Site | Chelyabinsk | Russia |
| Research Site | Irkutsk | Russia |
| Research Site | Izhevsk | Russia |
| Research Site | Kaluga | Russia |
| Research Site | Kazan' | Russia |
| Research Site | Kemerovo | Russia |
| Research Site | Khabarovsk | Russia |
| Research Site | Khanty-Mansiysk | Russia |
| Research Site | Kirov | Russia |
| Research Site | Kostroma | Russia |
| Research Site | Krasnodar | Russia |
| Research Site | Krasnoyarsk | Russia |
| Research Site | Kursk | Russia |
| Research Site | Lipetsk | Russia |
| Research Site | Makhachkala | Russia |
| Research Site | Moscow | Russia |
| Research Site | Nizhny Novgorod | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Omsk | Russia |
| Research Site | Orenburg | Russia |
| Research Site | Oryol | Russia |
| Research Site | Penza | Russia |
| Research Site | Perm | Russia |
| Research Site | Petrozavodsk | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Ryazan | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Samara | Russia |
| Research Site | Saratov | Russia |
| Research Site | Smolensk | Russia |
| Research Site | Stavropol | Russia |
| Research Site | Surgut | Russia |
| Research Site | Syktyvkar | Russia |
| Research Site | Tambov | Russia |
| Research Site | Tula | Russia |
| Research Site | Tver' | Russia |
| Research Site | Tyumen | Russia |
| Research Site | Ufa | Russia |
| Research Site | Ulan-Ude | Russia |
| Research Site | Ulyanovsk | Russia |
| Research Site | Vladimir | Russia |
| Research Site | Vladivostok | Russia |
| Research Site | Volgograd | Russia |
| Research Site | Voronezh | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Yekaterinburg | Russia |
| Research Site | Yoshkar-Ola | Russia |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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