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NCT Number: NCT04709263

Heart Failure Patients Registry

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Akhtubinsk, Astrakhan Oblast, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Mean age

    Time frame: Baseline

    At baseline of this study

  2. Proportion of men and women

    Time frame: Baseline

    At baseline of this study

  3. Proportion of patients with negative lifestyle factors

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

  5. 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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

  10. Proportion of patients with different types of HF based on LVEF

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: 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))

  16. 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

    Time frame: Baseline

    At baseline of this study

  17. Mean NT-proBNP level (or BNP)

    Time frame: Baseline

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

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

    Time frame: Baseline

    At baseline of this study

  19. 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

    Time frame: Baseline

    • Functional Class I - ≤3 points;
    • Functional Class II - from 4 to 6 points;
    • Functional Class III - from 7 to 9 points;
    • Functional Class IV - more than 9 points;

    At baseline of this study.

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

    Time frame: Baseline

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

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

    Time frame: Baseline

    • <90 mm Hg;
    • 90-99 mm Hg;
    • 100-109 mm Hg;
    • 110-119 mm Hg;
    • 120-139 mm Hg;
    • 140-159 mm Hg;
    • ≥160 mm Hg;

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    • <90 mm Hg;
    • ≥90 mm Hg;

    At baseline of this study

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

    Time frame: 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

  25. 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

    Time frame: Baseline

    • <30 mg/g;
    • 30-300 mg/g;
    • >300 mg/g;

    At baseline of this study

  26. 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)

    Time frame: Baseline

    At baseline of this study

  27. 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)

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    • Sinus rhythm;
    • AF / AFl;
    • Pacemaker rhythm;

    At baseline of this study

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

    Time frame: Baseline

    • <130 ms;
    • 130-150 ms;
    • >150 ms;

    At baseline of this study

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

    Time frame: 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

  35. Proportion of patients with HFrEF with implantable devices

    Time frame: 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

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

    Time frame: Baseline

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

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

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

    Time frame: Baseline

    At baseline of this study

  40. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: Priority-HF

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2021
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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