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Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies

NCT03412201 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2021-02-12

No results posted yet for this study

Summary

STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard oral heart failure medications during hospitalization for acute heart failure. Patients admitted for acute heart failure will be randomized within 2 days before discharge to either usual care or intensification of treatment with a beta-blocker, a renin-angiotensin system blocker, and a mineralocorticoid receptor blocker ("high intensity care" arm). In the "high intensity care" arm, patients' clinical signs and symptoms of heart failure will be assessed, and routine laboratory measures and biomarkers will be measured, at frequent post-discharge visits. When these measures indicate that it is safe to do so, the doses of the oral heart failure medications will be increased to optimal levels. Patients will be followed through 180 days from randomization. Patients assigned to the usual care group will be followed by their general physician and/or cardiologist according to local medical standards. Patients who were screened but did not meet eligibility criteria will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.

Conditions

Interventions

OTHER

Usual Care

Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards

OTHER

High Intensity Care

Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 2 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.

Sponsors & Collaborators

  • Hôpitaux Universitaires Saint-Louis-Lariboisière

    collaborator UNKNOWN

  • Momentum Research, Inc.

    collaborator INDUSTRY

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • INSERM UMR-942, Paris, France

    collaborator OTHER

  • Heart Initiative

    lead OTHER

Principal Investigators

  • Alexandre Mebazaa, MD PhD FESC · Inserm UMRS 942; Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-11
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • Argentina
  • Austria
  • Colombia
  • France
  • Hungary
  • Israel
  • Mozambique
  • Nigeria
  • Russia
  • Slovakia
  • South Africa
  • Tunisia

Study Locations

More Related Trials

Entities

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 NCT03412201 on ClinicalTrials.gov