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Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

NCT03988634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2025-03-06

Study results available
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Summary

The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days post-decompensation.

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Interventions

DRUG

sacubitril/valsartan

Sacubitril/valsartan (LCZ696) was available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily

DRUG

valsartan

Valsartan was available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily

DRUG

sacubitril/valsartan matching placebo

Sacubitril/valsartan (LCZ696) matching placebo was available as tablet form to be taken orally, twice daily

DRUG

valsartan matching placebo

Valsartan matching placebo was available as tablet form to be taken orally, twice daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-29
Primary Completion
2022-12-14
Completion
2022-12-14
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT03988634 on ClinicalTrials.gov