Heart Failure Patients Registry

NCT04709263 | Completed

• 1 other identifier: D1843R00323
• Study Type: observational
• Target: 19,990
• Locations: 1 country
• Sites: 65

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)

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (40)

• 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

  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

  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.

  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

  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

  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

  1. \<90 mm Hg; 2. ≥90 mm Hg; 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

  1. \<30 mg/g; 2. 30-300 mg/g; 3. \>300 mg/g; 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

  1. Sinus rhythm; 2. AF / AFl; 3. Pacemaker 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

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

  Baseline

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

  * 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

  Baseline

• Proportion of patients with HFrEF with implantable devices

  * 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

  Baseline

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

  * Revascularisation with PCI; * Revascularisation with CABG; * Valvular surgery; * Heart transplantation; 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

  * 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

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• The absence of signed ICF;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (65)

Research Site

Akhtubinsk, Astrakhan Oblast, Russia

Location

Research Site

Stary Oskol, Belgorod Oblast, Russia

Location

Research Site

Gurievsk, Kaliningrad Oblast, Russia

Location

Research Site

Rodniki Settlement, Kaliningrad Oblast, Russia

Location

Research Site

Korolyov, Moscow Oblast, Russia

Location

Research Site

Lyubertsy, Moscow Oblast, Russia

Location

Research Site

Pushchino, Moscow Oblast, Russia

Location

Research Site

Bor, Nizhniy Novgorod Region, Russia

Location

Research Site

Beslan, North Ossetia-Alania, Russia

Location

Research Site

Zubova Polyana Settlement, Respublika Mordoviya, Russia

Location

Research Site

Aramil, Sverdlovsk Oblast, Russia

Location

Research Site

Arkhangelsk, Russia

Location

Research Site

Astrakhan, Russia

Location

Research Site

Barnaul, Russia

Location

Research Site

Bataysk, Russia

Location

Research Site

Belgorod, Russia

Location

Research Site

Bryansk, Russia

Location

Research Site

Cheboksary, Russia

Location

Research Site

Chelyabinsk, Russia

Location

Research Site

Irkutsk, Russia

Location

Research Site

Izhevsk, Russia

Location

Research Site

Kaluga, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Kemerovo, Russia

Location

Research Site

Khabarovsk, Russia

Location

Research Site

Khanty-Mansiysk, Russia

Location

Research Site

Kirov, Russia

Location

Research Site

Kostroma, Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Krasnoyarsk, Russia

Location

Research Site

Kursk, Russia

Location

Research Site

Lipetsk, Russia

Location

Research Site

Makhachkala, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Omsk, Russia

Location

Research Site

Orenburg, Russia

Location

Research Site

Oryol, Russia

Location

Research Site

Penza, Russia

Location

Research Site

Perm, Russia

Location

Research Site

Petrozavodsk, Russia

Location

Research Site

Rostov-on-Don, Russia

Location

Research Site

Ryazan, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Saratov, Russia

Location

Research Site

Smolensk, Russia

Location

Research Site

Stavropol, Russia

Location

Research Site

Surgut, Russia

Location

Research Site

Syktyvkar, Russia

Location

Research Site

Tambov, Russia

Location

Research Site

Tula, Russia

Location

Research Site

Tver', Russia

Location

Research Site

Tyumen, Russia

Location

Research Site

Ufa, Russia

Location

Research Site

Ulan-Ude, Russia

Location

Research Site

Ulyanovsk, Russia

Location

Research Site

Vladimir, Russia

Location

Research Site

Vladivostok, Russia

Location

Research Site

Volgograd, Russia

Location

Research Site

Voronezh, Russia

Location

Research Site

Yaroslavl, Russia

Location

Research Site

Yekaterinburg, Russia

Location

Research Site

Yoshkar-Ola, Russia

Location

Related Links

• Redacted CSR Synopsis

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 14, 2021
• Study Start: December 21, 2020
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

RU (65)