Project description
Hypertension treatment with SGLT2 inhibitors
Hypertension (HTN) affects over 80 million EU citizens, contributing to 1 million deaths annually due to cardiovascular disease (CVD) and chronic kidney disease (CKD). It costs nearly EUR 300 billion each year in the EU, with patients facing risks from inadequate blood pressure control and ongoing organ damage. SGLT2 inhibitors (SGLT2i), which are effective in treating type-2 diabetes and heart failure, may also reduce BP and improve HTN outcomes. However, confirmation of their clinical benefit for HTN is needed. In this context, the EU-funded SGLT2-HYPE project tests the effects of dapagliflozin in people aged 65+ with inadequately controlled HTN. With 5 792 participants, the trial aims to reduce CVD and CKD morbidity and mortality and inform future treatment guidelines.
Objective
Hypertension (HTN) is a leading cause of cardiovascular disease (CVD), affecting >80 million EU citizens and >50% of people aged >65 years, resulting in 1 million deaths per year, predominantly from CVD and chronic kidney disease (CKD). The damage done by CVD costs almost €300 billion annually in the EU alone. Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. SGLT2 inhibitors (SGLT2i) are recommended for both type-2 diabetes and heart failure to reduce morbidity and mortality. SGLT2i reduce BP and might also improve outcomes for HTN by reducing end-organ damage through diverse other actions. However, confirmation that SGLT2i are clinically useful for the management of HTN is required to change guidelines and clinical practice. Therefore, we designed a multicentre, double-blind, randomised, placebo-controlled trial (SGLT2-HYPE), comparing the effects of dapagliflozin to placebo in people with inadequately controlled HTN, aged ≥65 years and with at least one other CVD or risk factor. The primary endpoint is a composite of CVD and CKD morbidity and mortality; a key secondary endpoint assesses quality of life. With 5,792 participants, assuming an annual placebo event rate of 2.5% compared to 2% with SGLT2i, a 3-year recruitment period and a minimum follow-up period of 4 years (7 years in total), the trial has 80% power for p<0.05 (two-sided). This guideline-relevant trial will inform guidelines and practice and may introduce a new therapeutic class for HTN, enhancing the current standard of care for an extremely common, treatable cause of CVD/CKD to reduce or prevent morbidity, disability and death. By engaging with key stakeholders, the trial aims to not only revolutionize care and wellbeing but also to achieve substantial healthcare cost savings (~€10 billion annually across the EU) and prevent >250,000 deaths globally each year.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- social sciences sociology demography mortality
- medical and health sciences clinical medicine cardiology cardiovascular diseases
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Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.3 - Non-Communicable and Rare Diseases
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-RIA - HORIZON Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-HLTH-2024-DISEASE-03-two-stage
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
23562 Lübeck
Germany
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Participants (17)
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23562 Lubeck
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6020 Innsbruck
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12808 Praha 2
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80333 Munchen
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40237 Düsseldorf
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
60323 FRANKFURT AM MAIN
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
67063 LUDWIGSHAFEN
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
28040 Madrid
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75654 Paris
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
40138 Bologna
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
LT-08406 VILNIUS
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9713 GH GRONINGEN
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
04 628 Warszawa
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4099-002 Porto
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1000 Ljubljana
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01601 Kyiv
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G12 8QQ Glasgow
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