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Dapagliflozin on Hypotensive Heart Failure Patients After Sacubitril/Valsartan Therapy

NCT04575675 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-08-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dapagliflozin

Dapagliflozin 10mg once daily

DRUG

Sacubitril-Valsartan

Sacubitril-Valsartan, maximal tolerated dosage

DRUG

Beta blocker

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

DRUG

Mineralocorticoid Receptor Antagonist

Mineralocorticoid receptor antagonist, including spironolactone or eplerenone

DEVICE

Cardiac resynchronization therapy and/or implantable cardioverter defibrillator

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

Sponsors & Collaborators

  • Cheng-Hsin General Hospital

    lead OTHER

Principal Investigators

  • Hung-Yu Chang, MD · Cheng-Hsin General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2020-11-25
Completion
2020-12-30

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575675 on ClinicalTrials.gov