Heart FailurePriority-HFNCT04709263
Heart Failure Patients Registry
An observational study of Heart Failure, run by AstraZeneca at 65 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 19,990 participants
- Where
- 65 sitesRussia
- Study dates
- 21 Dec 2020to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
Russia65 sites
Research Site
Akhtubinsk, Astrakhan Oblast
Research Site
Aramil, Sverdlovsk Oblast
Research Site
Arkhangelsk
Research Site
Astrakhan
Research Site
Barnaul
Research Site
Bataysk
Research Site
Belgorod
Research Site
Beslan, North Ossetia-Alania
Research Site
Bor, Nizhniy Novgorod Region
Research Site
Bryansk
Research Site
Cheboksary
Research Site
Chelyabinsk
Research Site
Gurievsk, Kaliningrad Oblast
Research Site
Irkutsk
Research Site
Izhevsk
Research Site
Kaluga
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Khabarovsk
Research Site
Khanty-Mansiysk
Research Site
Kirov
Research Site
Korolyov, Moscow Oblast
Research Site
Kostroma
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Kursk
Research Site
Lipetsk
Research Site
Lyubertsy, Moscow Oblast
Research Site
Makhachkala
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Orenburg
Research Site
Oryol
Research Site
Penza
Research Site
Perm
Research Site
Petrozavodsk
Research Site
Pushchino, Moscow Oblast
Research Site
Rodniki Settlement, Kaliningrad Oblast
Research Site
Rostov-on-Don
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Saratov
Research Site
Smolensk
Research Site
Stary Oskol, Belgorod Oblast
Research Site
Stavropol
Research Site
Surgut
Research Site
Syktyvkar
Research Site
Tambov
Research Site
Tula
Research Site
Tver'
Research Site
Tyumen
Research Site
Ufa
Research Site
Ulan-Ude
Research Site
Ulyanovsk
Research Site
Vladimir
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Voronezh
Research Site
Yaroslavl
Research Site
Yekaterinburg
Research Site
Yoshkar-Ola
Research Site
Zubova Polyana Settlement, Respublika Mordoviya
About this study
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)
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
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean age
At baseline of this study
Measured: Baseline
Proportion of men and women
At baseline of this study
Measured: Baseline
Proportion of patients with negative lifestyle factors
At baseline of this study
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with vaccination
At baseline of this study
Measured: Baseline
Proportion of patients with different types of HF based on LVEF
At baseline of this study
Measured: Baseline
Proportion of patients with T2DM comorbid with different types of HF based on LVEF
At baseline of this study
Measured: Baseline
Mean HbA1c (for patients with T2DM) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);
At baseline of this study
Measured: 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
Measured: Baseline
Mean BMI (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
At baseline of this study
Measured: 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))
Measured: 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
Measured: Baseline
Mean NT-proBNP level (or BNP)
NT-proBNP is measured in pg / mL. At baseline of this study
Measured: Baseline
Mean heart rate (HR) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);
At baseline of this study
Measured: 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
- 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.
Measured: Baseline
Mean SBP (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
SBP - Systolic blood pressure. At baseline of this study.
Measured: Baseline
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
Measured: Baseline
Mean Diastolic blood pressure (DBP) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
At baseline of this study
Measured: Baseline
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
Measured: 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
Measured: 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
- <30 mg/g;
- 30-300 mg/g;
- >300 mg/g;
At baseline of this study
Measured: 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
Measured: 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
Measured: Baseline
Mean LVEF (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
At baseline of this study
Measured: Baseline
Mean K+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
At baseline of this study
Measured: Baseline
Mean Na+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
At baseline of this study
Measured: Baseline
Mean hemoglobin level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
At baseline of this study
Measured: Baseline
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
Measured: Baseline
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start21 Dec 2020
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19,990 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709263
- Sponsor's protocol ID
- D1843R00323
- Acronym
- Priority-HF
- Status last verified
- May 2025
- First submitted
- 22 Dec 2020
- Last updated
- 15 May 2025
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04709263
- Acronym / sponsor ID
- Priority-HF / D1843R00323
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,990 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean age
Time frame: Baseline
At baseline of this study
Proportion of men and women
Time frame: Baseline
At baseline of this study
Proportion of patients with negative lifestyle factors
Time frame: Baseline
At baseline of this study
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
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
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
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
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
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
Proportion of patients with different types of HF based on LVEF
Time frame: Baseline
At baseline of this study
Proportion of patients with T2DM comorbid with different types of HF based on LVEF
Time frame: Baseline
At baseline of this study
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
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
Mean BMI (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
Time frame: Baseline
At baseline of this study
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))
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
Mean NT-proBNP level (or BNP)
Time frame: Baseline
NT-proBNP is measured in pg / mL. At baseline of this study
Mean heart rate (HR) (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF);
Time frame: Baseline
At baseline of this study
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
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.
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.
Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with SBP
Time frame: Baseline
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
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
Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with DBP
Time frame: Baseline
1. <90 mm Hg; 2. ≥90 mm Hg; At baseline of this study
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
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
1. <30 mg/g; 2. 30-300 mg/g; 3. >300 mg/g; At baseline of this study
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
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
Mean LVEF (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
Time frame: Baseline
At baseline of this study
Mean K+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
Time frame: Baseline
At baseline of this study
Mean Na+ level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
Time frame: Baseline
At baseline of this study
Mean hemoglobin level (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF)
Time frame: Baseline
At baseline of this study
Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different rhythm
Time frame: Baseline
1. Sinus rhythm; 2. AF / AFl; 3. Pacemaker rhythm; At baseline of this study
Proportion of patients (in total sample and subgroups of patients with HFrEF, HFmEF and HFpEF) with different QRS duration
Time frame: Baseline
1. <130 ms; 2. 130-150 ms; 3. >150 ms; At baseline of this study
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
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Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by AstraZeneca at 65 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean age (time frame: Baseline). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.