Dapagliflozin on Volume Vascular Outcomes.

NCT04869124 | Completed Phase 4 DMC

• 2 other identifiers: ESR-20-206012020-004143-89
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure，Congestive

Keywords

heart failure; congestive; hospitalization; blood volume; vascular function

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

• Change in blood volume (BV).

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

• Change in red blood cell volume (RBCV).

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

• Change in total hemoglobin mass (Hbmass).

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

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

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

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

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

Other Outcomes (9)

• First episode of worsening of heart failure (WHF).

  From baseline (0 weeks) to 12 weeks of treatment.

• Change in Kansas City cardiomyopathy questionnaire (KCCQ) score.

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

• Change in Pittsburgh sleep quality index (PSQI) score.

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

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

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

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dapagliflozin DRUG

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

Also known as: Forxiga

Dapagliflozin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Frank Ruschitzka: lead
• AstraZeneca: collaborator

Study Sites (1)

University Heart Center Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40601599 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Frank Ruschitzka, M.D.

  Cardiology, University Heart Center Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: A double-blind randomized placebo-controlled phase IV clinical trial.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: May 3, 2021
• Study Start: February 15, 2021
• Primary Completion: September 26, 2024
• Study Completion: October 28, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)