Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03200860
Other study ID # 2017-001679-22
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 18, 2017
Est. completion date September 18, 2019

Study information

Verified date April 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes, This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.


Description:

This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo. Treatment will be continued until 30 days after index event, and primary efficacy measurements will be carried out during hospitalization and safety events until 60 days after index hospitalisation.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 18, 2019
Est. primary completion date September 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female >18 years of age; Women of non-child-bearing potential must have a documentation of surgical sterilization (hysterectomy and/or bilateral oophorectomy) OR must have experienced menopause (no menses for >12 months). Women of child bearing potential must have a negative pregnancy test, AND must use highly effective methods of contraception during treatment with IP plus 5 days after the end of study drug administration. - Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening: 1. Dyspnea at rest or with minimal exertion 2. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph 3. BNP =350 pg/mL or NT-proBNP =1,400 pg/mL (for patients with AF: BNP=500 pg/mL or NT-proBNP =2,000 pg/mL) 4. Treated with loop diuretics at screening - Able to be randomized within 24 hours from presentation to the hospital - Able and willing to provide freely given written informed consent - eGFR (CKD-EPI) =30 ml/min/1.73m2 between presentation and randomization Exclusion Criteria: - Diabetes Mellitus Type I - Dyspnea primarily due to non-cardiac causes - Cardiogenic shock - Acute coronary syndrome within 30 days prior to randomization - Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization - Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L) - Pregnant or nursing (lactating) women - Current participation in any interventional study - Inability to follow instructions or comply with follow-up procedures - Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Empagliflozin 10 MG
10 mg daily, oral, 30 days
Placebo Oral Tablet
Matching Placebo, 10 mg daily, oral, 30 days

Locations

Country Name City State
Netherlands Jeroen Bosch Ziekenhuis Den Bosch Brabant
Netherlands TREANT Zorggroep Emmen Drenthe
Netherlands University Medical Center Groningen Groningen
Netherlands Antonius Ziekenhuis Sneek Friesland
Netherlands ISALA Klinieken Zwolle Overijssel

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14. — View Citation

Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Serious Adverse Events SAE including all cause mortality. Per request Clintrials.gov different from Protocol definition 60 days
Primary Dyspnea Change in Dyspnea on VAS analogue scale (AUC)
VAS Score is a measure/scale where patients on a scale from 0 to 100 can assign their current dyspnea score. 0 means there can be no worse dyspnea, 100 means it cannot get any better (perfect).
The change in Dyspnea VAS means higher score is better outcomes.
Individual changes in VAS score are be visualized (virtually) as a curve where the X-axis shows study day baseline to day 4, and y-axis shows VAS score. Using this approach, area under the curves for each study day (trapezoids) can be calculated, and added together, resulting in an overall VAS AUC score (mmxh) and change in VAS can be caculated
From baseline to Day 4
Primary Diuretic Response Weight change from baseline per 40 mg of Furosemide equivalent Total weight change from baseline to Day 4
Primary Length of Stay Hospital stay of Index admission within 60 days
Primary Plasma NTproBNP Change in NTproBNP From baseline to Day 4
Secondary Death and/or Heart Failure Re-admission Death and/or heart failure re-admission at day 30 Day 30
Secondary Inhospital Worsening Heart Failure, All Cause Mortality or Heart Failure Readmission at Day 60 Inhospital Worsening Heart Failure or All Cause mortality or Heart Failure Readmission at day 60 60 days
Secondary All Cause Mortality All Cause Mortality at 60 days 60 day
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