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Personalised Prospective Comparison of ARni With ArB in Patients With Natriuretic Peptide eLEvation

NCT04687111 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-05-11

No results posted yet for this study

Summary

Sacubitril-valsartan, an Angiotensin Receptor Blocker-Neprilysin Inhibitor (ARNI), currently marketed for the management of heart failure, has been shown to reduce cardiovascular morbidity and mortality in stage C heart failure with reduced ejection fraction. In stage C HFpEF, sacubitril-valsartan has also been shown to reduce left atrial volume index measured using echocardiography over a 9 month timeframe. The PARABLE study investigates the hypothesis that sacubitril-valsartan can provide benefits in terms of left atrial structure and function as well as left ventricular structure and function in asymptomatic (stage A/B HFpEF) patients. This is a prospective, randomised, double-blind, double-dummy, phase II study design. The patient population will have hypertension and/or diabetes together with preserved ejection fraction, elevated natriuretic peptide (NP) and abnormal left atrial volume index (LAVI, \> 28 mL/m2).

Conditions

  • Atrial Remodeling
  • Myocardial Dysfunction
  • Left Ventricular Remodeling
  • Left Ventricular Diastolic Dysfunction
  • Hypertension
  • Cardiovascular Morbidity
  • Fibrosis Myocardial
  • Inflammatory Myopathy
  • Atrial Arrhythmia

Interventions

DRUG

Sacubitril-Valsartan

Sacubitril-Valsartan is an Angiotensin Receptor blocker and Neprilysin Inhibitor

DRUG

Valsartan

Valsartan is an Angiotensin Receptor Blocker

Sponsors & Collaborators

  • The Heartbeat Trust

    collaborator OTHER

  • Mark Ledwidge

    lead OTHER

Principal Investigators

  • Fiona Ryan, Co-Investigator, PhD · Heartbeat Trust, 3 Crofton Terrace, Dun Laoghaire, Co Dublin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-16
Primary Completion
2021-06-11
Completion
2021-06-11

Countries

  • Ireland

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 NCT04687111 on ClinicalTrials.gov