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Heart Failure，CongestivePhase 4DAPA-VOLVONCT04869124

Dapagliflozin on Volume Vascular Outcomes.

A Phase 4 study testing Dapagliflozin in people with Heart Failure，Congestive, run by Frank Ruschitzka at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure，Congestive
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteSwitzerland
Study dates
15 Feb 2021to 28 Oct 2024
Phase
Phase 4
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

Who may be able to join

  • Male or female, age of 18 or older;
  • 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;
  • eGFR ≥ 30 mL/min/1.73 m2 (CKD-EPI formula) at enrolment;
  • Provision of signed informed consent prior to any study specific procedure;

Who cannot join

  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
  • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor;
  • Participation in another study with investigational drug within the 30 days preceding and during the present study;
  • Type 1 diabetes mellitus;
  • Symptomatic hypotension or systolic blood pressure <90 mmHg at 2 out of 3 measurements either at visit 1 or visit 2;
  • 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;
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  • 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];
  • Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization;
  • HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy or uncorrected primary valvular disease;
  • Symptomatic bradycardia or second or third degree heart block without a pacemaker;
  • Severe (eGFR <20 mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease;
  • Women who are pregnant or breast feeding;
  • Intention to become pregnant during the course of the study;
  • Known or suspected non-compliance, drug or alcohol abuse;
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant;
  • Patients with severely restricted liver function;
  • Patients with recurrent mycotic genital infections;

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Heart Center Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Effects of Dapagliflozin on Blood Volume Status and Vascular Function in Clinically Compensated Heart Failure Patients After an Acute Heart Failure Event.

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.

Read the 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.

Being tested
Dapagliflozin, Placebo
Keywords
heart failure, congestive, hospitalization, blood volume, vascular function
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Forxiga

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

  • PlaceboDrug

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

Study groups in NCT04869124
Study groupRoleWhat they receive
DapagliflozinActive comparatorDapagliflozin tablet (10mg/tablet), orally, once daily for 12 weeks.
Receives: Drug: Dapagliflozin
PlaceboPlacebo comparatorPlacebo tablet, matching Dapglilflozin, orally, once daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in relative plasma volume status (PVS).

    Change in relative plasma volume status (PVS) from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The plasma volume (PV) will be measured via optimized CO-rebreathing technique.

    Measured: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment.

Secondary outcomes (11)

  1. Change in blood volume (BV).

    Change in BV from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The BV will be measured via optimized CO-rebreathing technique.

    Measured: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment.

  2. Change in red blood cell volume (RBCV).

    Change in RBCV from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The RBCV will be measured via optimized CO-rebreathing technique.

    Measured: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment.

  3. Change in total hemoglobin mass (Hbmass).

    Change in Hbmass from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The Hbmass will be measured via optimized CO-rebreathing technique.

    Measured: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment.

  4. Change in extracellular to total body water ratio (ECW/TBW).

    Change in ECW/TBW ratio from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The ECW/TBW ratio will be measured via direct segmental multi-frequency bioelectrical impedance analaysis (DSM-BIA).

    Measured: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment.

  5. Change in intracellular to total body water ratio (ICW/TBW).

    Change in ICW/TBW ratio from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The ICW/TBW ratio will be measured via direct segmental multi-frequency bioelectrical impedance analaysis (DSM-BIA).

    Measured: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment.

  6. Change in flicker-light induced retinal arteriolar dilatation (FIDa).

    Change in FIDa from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The FIDa will be measured via dynamic retinal vessel analysis (DVA).

    Measured: Change between baseline (0 weeks) and after 12 weeks of treatment.

  7. Change in flicker-light induced retinal venular dilatation (FIDv).

    Change in FIDv from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The FIDv will be measured via dynamic retinal vessel analysis (DVA).

    Measured: Change between baseline (0 weeks) and after 12 weeks of treatment.

  8. Change in retinal arterial to venous ratio (AVR).

    Change in AVR from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The AVR will be measured via static retinal vessel analysis (SVA).

    Measured: Change between baseline (0 weeks) and after 12 weeks of treatment.

  9. Change in pulse wave velocity (PWV).

    Change in PWV from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The PWV as measure of arterial stiffness (AS) will be assessed via planar tonometry pulse wave analysis (PWA).

    Measured: Change between baseline (0 weeks) and after 12 weeks of treatment.

  10. Change in flow-mediated dilatation (FMD) of the brachial artery.

    Change in FMD from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The FMD as measure of endothelial function will be assessed via arm sonography and short-term cuff-mediated arm ischemia.

    Measured: Change between baseline (0 weeks) and after 12 weeks of treatment.

  11. Change in glyceryl-trinitrate-(GTN) induced dilatation of the brachial artery.

    Change in GTN-induced dilatation of the brachial artery from baseline to 12 weeks of dapagliflozin treatment in comparison to placebo will be assessed. The GTN-induced dilatation of the brachial artery will be measured via arm sonography and sublingual GTN-puff.

    Measured: Change between baseline (0 weeks) and after 12 weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start15 Feb 2021
  3. Primary completion26 Sep 2024
  4. Study completion28 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blind randomized placebo-controlled phase IV clinical trial.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869124
Sponsor's protocol ID
ESR-20-20601
Other IDs
2020-004143-89
Acronym
DAPA-VOLVO
Status last verified
Nov 2024
First submitted
4 Jan 2021
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40601599

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Heart Failure，Congestive, run by Frank Ruschitzka at 1 site in Switzerland.

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 4 inclusion and 17 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in relative plasma volume status (PVS). (time frame: Change between baseline (0 weeks) and after 2, 6 and 12 weeks of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04869124, which also lists 1 linked publication.

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 12 Nov 2024.

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