Dapagliflozin on Volume Vascular Outcomes.

NCT ID: NCT04869124

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2024-10-28

Brief Summary

The purpose of the DAPA-VOLVO trial is to investigate the effects of Dapagliflozin on top of recommended standard therapy on volume status and vascular function in clinically stable de novo or chronic heart failure patients after hospitalization because of an acute decompensated heart failure event.

Detailed Description

Recent clinical trials found that Dapagliflozin can reduce the risk of cardiovascular events, hospitalization and death in heart failure (HF) patients with reduced left ventricular ejection fraction (HFrEF) in the presence of absence of diabetes. Additional trials are ongoing to investigate whether these results can be translated also to HF-patients with preserved ejection fraction (HFpEF). However, the underlying mechanisms leading to the improved clinical outcomes are not completely understood but the beneficial effects of Dapagliflozin on volume status and vascular function are discussed as potential key factors. This study is designed as a mechanistic study to investigate the impact of Dapagliflozin on volume status and vascular function in clinically stable de novo or chronic heart failure patients after hospitalization/ ambulatory care because of an acute decompensated heart failure (ADHF) event. After being informed about the study and potential risks all patients given written informed consent will be screened for the defined eligibility criteria and thereafter randomized in a double-blind manner (patients, investigators) 1:1 ratio to either receive the sodium-glucose co-transporter 2 inhibitor (SGLT2i) Dapagliflozin (10mg/day) or Placebo on top of recommended standard therapy for in total 12 weeks. The results of this study may provide new mechanistic insight into the beneficial effects of Dapagliflozin on volume regulation and vascular function and have great potential to contribute to change current clinical guidelines in the management of patients with heart failure.

Conditions

Heart Failure，Congestive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dapagliflozin

Dapagliflozin tablet (10mg/tablet), orally, once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin propanediol (FORXIGA) tablet: 10 mg once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.

Placebo

Placebo tablet, matching Dapglilflozin, orally, once daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet, matching Dapagliflozin, once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.

Interventions

Dapagliflozin

Dapagliflozin propanediol (FORXIGA) tablet: 10 mg once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.

Intervention Type: DRUG

Placebo

Placebo tablet, matching Dapagliflozin, once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Forxiga

Eligibility Criteria

Inclusion Criteria

1. Male or female, age of 18 or older;

2. Patients with documented diagnosis of chronic or de novo heart failure (NYHA II-IV) and clinically stabilized (considered for hospital discharge) after hospitalization/ ambulatory care because of an acute decompensated (congestive) heart failure (ADHF) event;

3. eGFR ≥ 30 mL/min/1.73 m2 (CKD-EPI formula) at enrolment;

4. Provision of signed informed consent prior to any study specific procedure;

Exclusion Criteria

1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;

2. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor;

3. Participation in another study with investigational drug within the 30 days preceding and during the present study;

4. Type 1 diabetes mellitus;

5. Symptomatic hypotension or systolic blood pressure <90 mmHg at 2 out of 3 measurements either at visit 1 or visit 2;

6. Coronary revascularization (percutaneous coronary intervention because of STEMI or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization;

7. Implantation of a CRT device within 12 weeks prior to enrolment or intent to implant a CRT device during 12 weeks of study observation period if indicated according to the actual guidelines [11];

8. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization;

9. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy or uncorrected primary valvular disease;

10. Symptomatic bradycardia or second or third degree heart block without a pacemaker;

11. Severe (eGFR <20 mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease;

12. Women who are pregnant or breast feeding;

13. Intention to become pregnant during the course of the study;

14. Known or suspected non-compliance, drug or alcohol abuse;

15. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant;

16. Patients with severely restricted liver function;

17. Patients with recurrent mycotic genital infections;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Frank Ruschitzka

OTHER

Sponsor Role: lead

Responsible Party

Frank Ruschitzka

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frank Ruschitzka, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cardiology, University Heart Center Zurich

Locations

University Heart Center Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Bitos K, Laptseva N, Haider T, Rossi VA, Nagele MP, Barthelmes J, Ruschitzka F, Sudano I, Flammer AJ. Effects of dapagliflozin on blood volume status and vascular outcomes in clinically stabilized heart failure patients after an acute decompensated heart failure event (DAPA-VOLVO study): Protocol of a double-blind randomized controlled clinical trial. PLoS One. 2025 Jul 2;20(7):e0325668. doi: 10.1371/journal.pone.0325668. eCollection 2025.

Reference Type: DERIVED

PMID: 40601599 (View on PubMed)

Other Identifiers

2020-004143-89

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ESR-20-20601

Identifier Type: -

Identifier Source: org_study_id