Clinical trial NCT04709263: Heart Failure Patients Registry
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 19990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Mean age
timeFrame: Baseline
measure: Proportion of men and women
timeFrame: Baseline
measure: Proportion of patients with negative lifestyle factors
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different etiology of CHF
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Mean duration of comorbidities listed in previous paragraph (p. 5) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different chronic comorbidities
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with history of COVID-19
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with vaccination
timeFrame: Baseline
measure: Proportion of patients with different types of HF based on LVEF
timeFrame: Baseline
measure: Proportion of patients with T2DM comorbid with different types of HF based on LVEF
timeFrame: Baseline
measure: Mean HbA1c (for patients with T2DM) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);
timeFrame: Baseline
measure: Proportions of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different levels of HbA1c (for patients with T2DM)
timeFrame: Baseline
measure: Mean BMI (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different BMI levels
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Mean NT-proBNP level (or BNP)
timeFrame: Baseline
measure: Mean heart rate (HR) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Mean SBP (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with SBP
timeFrame: Baseline
measure: Mean Diastolic blood pressure (DBP) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with DBP
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with concomitant CKD of different stages
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: Baseline
measure: Mean LVEF (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Mean K+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Mean Na+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Mean hemoglobin level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different rhythm
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different QRS duration
timeFrame: Baseline
measure: Proportion of patients receiving different classes of drugs for treatment of HF
timeFrame: Baseline
measure: Proportion of patients with HFrEF with implantable devices
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with cardiac surgery and endovascular procedures
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving dual disease-modifying therapy
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving triple disease-modifying therapy
timeFrame: Baseline
measure: Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) receiving quadruple disease-modifying therapy
timeFrame: Baseline
measure: 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
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Akhtubinsk
country: Russian Federation
facility: Research Site
state: Astrakhan Region
city: Stary Oskol
country: Russian Federation
facility: Research Site
state: Belgorod Region
city: Gurievsk
country: Russian Federation
facility: Research Site
state: Kaliningrad Region
city: Rodniki Settlement
country: Russian Federation
facility: Research Site
state: Kaliningrad Region
city: Korolev
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Lyubertsy
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Pushchino
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Bor
country: Russian Federation
facility: Research Site
state: Nizhniy Novgorod Region
city: Beslan
country: Russian Federation
facility: Research Site
state: North Ossetia
city: Zubova Polyana Settlement
country: Russian Federation
facility: Research Site
state: Republic Of Mordovia
city: Aramil
country: Russian Federation
facility: Research Site
state: Sverdlovsk Region
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Astrakhan
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Bataysk
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Bryansk
country: Russian Federation
facility: Research Site
city: Cheboksary
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khabarovsk
country: Russian Federation
facility: Research Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Kostroma
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Makhachkala
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orel
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Surgut
country: Russian Federation
facility: Research Site
city: Syktyvkar
country: Russian Federation
facility: Research Site
city: Tambov
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Tyumen
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Ulan-Ude
country: Russian Federation
facility: Research Site
city: Ulyanovsk
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yoshkar-Ola
country: Russian Federation
facility: Research Site
Study officials:
References: