Priority-HF: Heart Failure Patients Registry

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04709263
Collaborator
(none)
20,000
Enrollment
2
Locations
36.2
Anticipated Duration (Months)
10000
Patients Per Site
276
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official 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)
    Actual Study Start Date :
    Dec 23, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Mean age [Baseline]

      At baseline of this study

    2. Proportion of men and women [Baseline]

      At baseline of this study

    3. Proportion of patients with negative lifestyle factors [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 [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 [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) [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 [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 [Baseline]

      At baseline of this study

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

      At baseline of this study

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

      At baseline of this study

    11. Proportion of patients with T2DM comorbid with different types of HF based on LVEF [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); [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) [Baseline]

      At baseline of this study

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

      At baseline of this study

    17. Mean NT-proBNP level (or BNP) [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); [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 [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) [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 [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) [Baseline]

      At baseline of this study

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

      At baseline of this study

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

      At baseline of this study

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

      At baseline of this study

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

      At baseline of this study

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. Age ≥ 18 years at the time of inclusion;

    2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;

    3. 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:
    1. The absence of signed ICF;

    2. The participation in any randomised controlled trial within 3 months before the inclusion in this study or during the participation in this study.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Municipal Autonomous Institution "Central City Hospital No. 20"EkaterinburgRussian Federation
    2City policlinic NO 11 of KrasnodarKrasnodarRussian Federation

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04709263
    Other Study ID Numbers:
    • D1843R00323
    First Posted:
    Jan 14, 2021
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by AstraZeneca
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2022