Heart Failure Patients Registry

Heart Failure Clinical Trial

— Priority-HF  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04709263
• Other study ID #: D1843R00323
• Status: Active, not recruiting
• Start date: December 23, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20514
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Russian Federation	Research Site	Akhtubinsk	Astrakhan Region
Russian Federation	Research Site	Aramil	Sverdlovsk Region
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Astrakhan
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Bataysk
Russian Federation	Research Site	Belgorod
Russian Federation	Research Site	Beslan	North Ossetia
Russian Federation	Research Site	Bor	Nizhniy Novgorod Region
Russian Federation	Research Site	Bryansk
Russian Federation	Research Site	Cheboksary
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Gurievsk	Kaliningrad Region
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Kaluga
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Khabarovsk
Russian Federation	Research Site	Khanty-Mansiysk
Russian Federation	Research Site	Kirov
Russian Federation	Research Site	Korolev	Moscow Region
Russian Federation	Research Site	Kostroma
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Kursk
Russian Federation	Research Site	Lipetsk
Russian Federation	Research Site	Lyubertsy	Moscow Region
Russian Federation	Research Site	Makhachkala
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Orel
Russian Federation	Research Site	Orenburg
Russian Federation	Research Site	Penza
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Petrozavodsk
Russian Federation	Research Site	Pushchino	Moscow Region
Russian Federation	Research Site	Rodniki Settlement	Kaliningrad Region
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Smolensk
Russian Federation	Research Site	Stary Oskol	Belgorod Region
Russian Federation	Research Site	Stavropol
Russian Federation	Research Site	Surgut
Russian Federation	Research Site	Syktyvkar
Russian Federation	Research Site	Tambov
Russian Federation	Research Site	Tula
Russian Federation	Research Site	Tver
Russian Federation	Research Site	Tyumen
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Ulan-Ude
Russian Federation	Research Site	Ulyanovsk
Russian Federation	Research Site	Vladimir
Russian Federation	Research Site	Vladivostok
Russian Federation	Research Site	Volgograd
Russian Federation	Research Site	Voronezh
Russian Federation	Research Site	Yaroslavl
Russian Federation	Research Site	Yoshkar-Ola
Russian Federation	Research Site	Zubova Polyana Settlement	Republic Of Mordovia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean age	At baseline of this study	Baseline
Primary	Proportion of men and women	At baseline of this study	Baseline
Primary	Proportion of patients with negative lifestyle factors	At baseline of this study	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with vaccination	At baseline of this study	Baseline
Primary	Proportion of patients with different types of HF based on LVEF	At baseline of this study	Baseline
Primary	Proportion of patients with T2DM comorbid with different types of HF based on LVEF	At baseline of this study	Baseline
Primary	Mean HbA1c (for patients with T2DM) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);	At baseline of this study	Baseline
Primary	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
Primary	Mean BMI (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)	At baseline of this study	Baseline
Primary	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
Primary	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
Primary	Mean NT-proBNP level (or BNP)	NT-proBNP is measured in pg / mL. At baseline of this study	Baseline
Primary	Mean heart rate (HR) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);	At baseline of this study	Baseline
Primary	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	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.	Baseline
Primary	Mean SBP (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)	SBP - Systolic blood pressure. At baseline of this study.	Baseline
Primary	Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with SBP	<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	Baseline
Primary	Mean Diastolic blood pressure (DBP) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)	At baseline of this study	Baseline
Primary	Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with DBP	<90 mm Hg; =90 mm Hg; At baseline of this study	Baseline
Primary	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/?, 1)^a x max(SCr/?, 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, ? = 0.7 (females) or 0.9 (males), a = -0.329 (females) or -0.411 (males), min = indicates the minimum of SCr/? or 1, max = indicates the maximum of SCr/? or 1, age = years.; At baseline of this study	Baseline
Primary	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	<30 mg/g; 30-300 mg/g; >300 mg/g; At baseline of this study	Baseline
Primary	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
Primary	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
Primary	Mean LVEF (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)	At baseline of this study	Baseline
Primary	Mean K+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)	At baseline of this study	Baseline
Primary	Mean Na+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)	At baseline of this study	Baseline
Primary	Mean hemoglobin level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)	At baseline of this study	Baseline
Primary	Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different rhythm	Sinus rhythm; AF / AFl; Pacemaker rhythm; At baseline of this study	Baseline
Primary	Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different QRS duration	<130 ms; 130-150 ms; >150 ms; At baseline of this study	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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