Dapagliflozin on Hypotensive Heart Failure Patients After Sacubitril/Valsartan Therapy

Sponsor
Cheng-Hsin General Hospital
Study ID
NCT04575675
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10mg once daily
  • Sacubitril-Valsartan — DRUG
    Sacubitril-Valsartan, maximal tolerated dosage
  • Beta blocker — DRUG
    Cardio-selective beta-blocker, including carvedilol, bisoprolol, metoprolol or nebivolol
  • Mineralocorticoid Receptor Antagonist — DRUG
    Mineralocorticoid receptor antagonist, including spironolactone or eplerenone
  • Cardiac resynchronization therapy and/or implantable cardioverter defibrillator — DEVICE
    CRT-P, CRT-D or ICD if clinically indicated

Study Details

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.

Key Dates

Start date
May 29, 2020
Status verified
Jul 2021
Primary completion
Nov 25, 2020
Completion
Dec 30, 2020

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin with standard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT
  • Placebo Comparator: Standard of care
    Standard-of-care therapies for heart failure, including sacubitril/valsartan, beta-blocker, MRA, ICD and CRT

Primary Outcome Measure

6-minute walking distance [ Time Frame: 12 weeks ]

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