NCT04575675

Brief Summary

The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive heart failure patients receiving chronic sacubitril/valsartan treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

August 26, 2020

Last Update Submit

July 27, 2021

Conditions

HypotensionHeart Failure

Keywords

Heart failureDapagliflozinSacubitril/valsartan

Outcome Measures

Primary Outcomes (1)

  • 6-minute walking distance

    Measuring walking distance within 6 minutes

    12 weeks

Secondary Outcomes (2)

  • EQ-5D-5L

    12 weeks

  • EQ-Visual analogue scale (EQ-VAS)

    12 weeks

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT

Drug: DapagliflozinDrug: Sacubitril-ValsartanDrug: Beta blockerDrug: Mineralocorticoid Receptor AntagonistDevice: Cardiac resynchronization therapy and/or implantable cardioverter defibrillator

Standard of care

PLACEBO COMPARATOR

Standard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT

Drug: Sacubitril-ValsartanDrug: Beta blockerDrug: Mineralocorticoid Receptor AntagonistDevice: Cardiac resynchronization therapy and/or implantable cardioverter defibrillator

Interventions

DapagliflozinDRUG

Dapagliflozin 10mg once daily

Also known as: Forxiga
Dapagliflozin
Sacubitril-ValsartanDRUG

Sacubitril-Valsartan, maximal tolerated dosage

Also known as: Entresto
DapagliflozinStandard of care
Beta blockerDRUG

Cardio-selective beta-blocker, including carvedilol, bisoprolol, metoprolol or nebivolol

Also known as: Concor, Betaloc zok, Nebilet, Carvedilol
DapagliflozinStandard of care
Mineralocorticoid Receptor AntagonistDRUG

Mineralocorticoid receptor antagonist, including spironolactone or eplerenone

Also known as: Aldactin, Inspra
DapagliflozinStandard of care
Cardiac resynchronization therapy and/or implantable cardioverter defibrillatorDEVICE

CRT-P, CRT-D or ICD if clinically indicated

DapagliflozinStandard of care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • chronic symptomatic HF with New York Heart Association (NYHA) class II-IV and left ventricular ejection fraction (LVEF) less than 40%
  • treatment with stable and maximal tolerable dose of Sac/Val, beta-blocker with or without mineralocorticoid receptor antagonist
  • minute walking-distance (6MWD)≥ 100meters and ≤425 meters at enrollment
  • systolic blood pressure ≤100 mmHg at enrollment

You may not qualify if:

  • hemodialysis
  • severe co-morbidities with life expectancy less than 1 year
  • type 1 diabetes mellitus
  • ever treated with any type of sodium glucose cotransporter 2 inhibitor (SGLT2i)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

HypotensionHeart Failure

Interventions

dapagliflozinsacubitril and valsartan sodium hydrate drug combinationAdrenergic beta-AntagonistsBisoprololNebivololCarvedilolMineralocorticoid Receptor AntagonistsEplerenone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesEthanolaminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCarbazolesIndolesHeterocyclic Compounds, 3-RingHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsDiuretics, Potassium SparingDiureticsNatriuretic AgentsLactonesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hung-Yu Chang, MD

    Cheng-Hsin General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

August 26, 2020

First Posted

October 5, 2020

Study Start

May 29, 2020

Primary Completion

November 25, 2020

Study Completion

December 30, 2020

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)