NCT06046612

Empagliflozin for Peripheral Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

The Effect of Empagliflozin on Peripheral Microvascular Dysfunction in Heart Failure With

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this low-intervention clinical trial is to learn about the effect of the drug Empagliflozin in patients with heart failure with preserved ejection fraction. The main questions it aims to answer are: * What is the effect of treatment with Empagliflozin after 3 months on peripheral microvascular function * Do clinical correlates for worse microvascular function exist, and thus identify patients that could possibly benefit most from empagliflozin treatment Patients will use Empagliflozin, prescribed by their treating physician. Before the start of treatment and after 3 months they will be asked to * Fill out a quality of life questionnaire * Draw 4 tubes of blood * Undergo non-invasive measurement of the blood flow of the microvasculature in the forearm (using laser speckle contrast analysis)

Detailed description

Heart failure (HF) with preserved ejection fraction (HFpEF), is an important public health problem with a poor prognosis and many people are affected by it. Microvascular dysfunction (MVD) is thought to play an important role in this complex syndrome. MVD may lead to disease progression in HFpEF. For the past years the main focus of HFpEF treatment has been on symptom relieve and diagnosing and treating co-occurring disease, such as hypertension or diabetes. Recently, the sodium-glucose co-transporter 2 (SGLT-2) inhibitor Empagliflozin was suggested to be added to this list of treatments. This drug was proven to reduce the combined risk of cardiovascular death or HF hospitalization in HFpEF patients in the EMPEROR-PRESERVED trial. Preclinical studies have proposed an important role for microvascular function in the mechanism of action of empagliflozin in HFpEF. The microvasculature may also play an important role in the etiology of HFpEF. The microcirculation in the skin is accessible and suitable for analysis of microvascular function. Laser speckle contrast analysis (LASCA) is a relatively new and non-invasive analysis that measures the blood flow in the skin microvasculature using several stimuli. In HFpEF patients no clinical research has been conducted to evaluate the effect of Empagliflozin on MVD, despite its seemingly important role in the HFpEF etiology. We hypothesize that empagliflozin improves microvascular function in HFpEF patients. Understanding of the effects of this important drug in the treatment of HFpEF is essential to optimize its use in this growing population. Key clinical determinants may exist that improve our ability to determine which patients at what disease stage can specifically benefit from this intervention. The patients with the strongest improvement in MVD during treatment with Empagliflozin might benefit most regarding cardiac function or wellbeing.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Microvascular Dysfunction

Interventions

Type	Name	Description
DRUG	Participants receive 10mg Empaglifozin once daily on prescription from their treating physician. This is not an intervention in this trial, but part of their normal HFpEF treatment	The investigational medicinal product investigated in this trial (empagliflozin) is authorised for use in the European Union by the European Medicines Agency and will be used in accordance with the terms of the marketing authorization. The treating physician (cardiologist) will determine the indication for empagliflozin use, discuss the benefits and risks with the patient, prescribe the drug, and provide follow up after starting the drug, according to normal clinical practice. The study participants are not assigned to a particular therapeutic strategy decided by the clinical trial protocol.

Timeline

• Start date: 2023-02-13
• Primary completion: 2024-08-13
• Completion: 2025-02-13
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Netherlands