Dapagliflozin on Volume Vascular Outcomes.

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04869124
Study type	Interventional
Source	University of Zurich
Contact	Thomas Haider, M.D.
Phone	+41(0)442552280
Email	thomas.haider@usz.ch
Status	Recruiting
Phase	Phase 4
Start date	February 15, 2021
Completion date	December 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03727646` - Nicotinamide Riboside in LVAD Recipients	Early Phase 1
Withdrawn	`NCT03519477` - Comprehensive Medication Monitoring on Heart Failure Patient Outcomes	N/A
Recruiting	`NCT05596760` - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers	N/A
Recruiting	`NCT05227872` - PVF in Decongestion of Heart Failure
Recruiting	`NCT05543720` - Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study	N/A
Completed	`NCT04572425` - Virtual Reality for Pain Management in Advanced Heart Failure	N/A
Recruiting	`NCT03202329` - Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery	N/A
Recruiting	`NCT03830957` - Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker	N/A
Recruiting	`NCT02672618` - Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology	N/A
Recruiting	`NCT04179643` - NAN-101 in Patients With Class III Heart Failure	Phase 1
Completed	`NCT04129658` - Heart Failure in Southern Sweden
Not yet recruiting	`NCT05591443` - Artificial Intelligence and Smart Wearable Technologies for Early Detection of Acute Heart Failure
Completed	`NCT03387813` - Hemodynamic-GUIDEd Management of Heart Failure	N/A
Completed	`NCT04628325` - Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)	Phase 3
Completed	`NCT03187470` - Left Ventricular Dyssynchrony in Multipole Pacing	N/A
Completed	`NCT03385837` - Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients
Completed	`NCT04281849` - Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program	N/A
Not yet recruiting	`NCT04403659` - Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study	N/A
Terminated	`NCT04142788` - RELieving Increasing oEdema Due to Heart Failure	Phase 4
Active, not recruiting	`NCT04283994` - Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Dapagliflozin on Volume Vascular Outcomes. — DAPA-VOLVO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms