The effect of empagliflozin on peripheral microvascular dysfunction in heart failure with preserved ejection fraction

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Maastricht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

13 Feb 2023 → 1 Dec 2024

Decision date (initial)

2022-11-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of this study is to evaluate the effect of treatment with the SGLT-2 inhibitor empagliflozin after 3 months on peripheral microvascular function, defined as the cutaneous vascular conductance (CVC) in the forearm skin, measured by laser speckle contrast analysis (LASCA) during iontophoresis of achetylcholin, insulin and nitroprusside, in HFpEF patients

Secondary objectives 4

1. To evaluate the effect of the SGLT-2 inhibitor empagliflozin on additional parameters of peripheral microvascular function measured by LASCA in the forearm skin in HFpEF patients.
2. To evaluate clinical correlates for worse CVC in HFpEF, defined as diminished perfusion in the forearm skin measured with LASCA, and thus identify patients that could possibly benefit most from empagliflozin treatment.
3. To evaluate if elevation of serum ketones is a mediator for improved microvascular function by empagliflozin in HFpEF.
4. To evaluate if quality of life as measured by the EQ5D-5L questionnaire is correlated to the CVC as measured by LASCA in HFpEF patients.

Conditions and MedDRA coding

Heart failure with preserved ejection fraction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. HFpEF diagnosis according to the ESC 2021 Guidelines for the diagnosis and treatment of acute and chronic heart failure
2. Ability to understand and speak the Dutch language
3. Treatment with empagliflozin 10mg once daily is planned to be started by the treating physician
4. Signed informed consent

Exclusion criteria 8

1. Unable or unwilling to sign informed consent
2. Under 18 years of age
3. Contra-indication to the use of empagliflozin
4. Use of empagliflozin or other SGLT-2 inhibitor at baseline
5. Insulin dependent patients (Fasting conditions cause a risk of ketoacidosis in these patients)
6. Subjects currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study
7. Any condition that interferes with the correct execution of the LASCA measurements (patient is unable to keep arms motionless during the measurements, any condition that does not allow disposables to be attached to the forearm skin)
8. Any other reason that makes it undesirable for patient to use empagliflozin according to the researcher / treating physician

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cutaneous vascular conductance (CVC) (Skin blood flow divided by the mean arterial pressure) as measured by LASCA

Secondary endpoints 4

1. Baseline bloodflow and area under the curve as measured by LASCA
2. Cutaneous vascular conductance (CVC)
3. Serum ketone levels in mmol/L
4. EQ5D-5L questionnaire score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Maastricht

Sponsor organisation

University Hospital Maastricht

Address

P. O. Box 5800

City

Maastricht

Postcode

6202 AZ

Country

Netherlands

Scientific contact point

Organisation

University Hospital Maastricht

Contact name

Principal Investigator

Public contact point

Organisation

University Hospital Maastricht

Contact name

Principal Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications