NCT04687111: PARABLE

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

Status unknown Phase 2 Last updated 11 May 2021

What this trial tests

Phase 2 trial testing Sacubitril-Valsartan in Atrial Remodeling in 250 participants. Status unknown.

Timeline

16 December 2015

Primary endpoint
11 June 2021

11 June 2021

Quick facts

Lead sponsor	Mark Ledwidge
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	250
Start date	16 December 2015
Primary completion	11 June 2021
Estimated completion	11 June 2021
Sites	2 locations across Ireland

Drugs / interventions tested

• Sacubitril-Valsartan — full drug profile →
• Valsartan (VALSARTAN) — full drug profile →

Conditions studied

• Atrial Remodeling — all drugs for Atrial Remodeling →
• Myocardial Dysfunction — all drugs for Myocardial Dysfunction →
• Left Ventricular Remodeling — all drugs for Left Ventricular Remodeling →
• Left Ventricular Diastolic Dysfunction — all drugs for Left Ventricular Diastolic Dysfunction →

Sponsor

Mark Ledwidge

Who can join

40 and older, any sex, with Atrial Remodeling or Myocardial Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Sacubitril/Valsartan vs Valsartan on Left Atrial Volume in Patients With Pre-Heart Failure With Preserved Ejection Fraction: The PARABLE Randomized Clinical Trial.
   Ledwidge M, Dodd JD, Ryan F, Sweeney C, et al · · 2023 · cited 40× · PMID 36884247 · DOI 10.1001/jamacardio.2023.0065
2. The NO-cGMP-PKG Axis in HFpEF: From Pathological Mechanisms to Potential Therapies.
   Cai Z, Wu C, Xu Y, Cai J, et al · · 2023 · cited 33× · PMID 36818566 · DOI 10.14336/ad.2022.0523
3. STOP-HF Trial: Higher Endogenous BNP and Cardiovascular Protection in Subjects at Risk for Heart Failure.
   Cannone V, Ledwidge M, Watson C, McKie PM, et al · · 2021 · cited 15× · PMID 34222720 · DOI 10.1016/j.jacbts.2021.05.001
4. Modern Approaches for the Treatment of Heart Failure: Recent Advances and Future Perspectives.
   Popa IP, Haba MȘC, Mărănducă MA, Tănase DM, et al · · 2022 · cited 11× · PMID 36145711 · DOI 10.3390/pharmaceutics14091964
5. Sacubitril/Valsartan attenuates progression of diabetic cardiomyopathy through immunomodulation properties: an opportunity to prevent progressive disease.
   Karuna N, Kerrigan L, Edgar K, Ledwidge M, et al · · 2025 · cited 4× · PMID 40369551 · DOI 10.1186/s12933-025-02741-5
6. ECR 2025 Book of Abstracts.
   · 2025 · PMID 40676413 · DOI 10.1186/s13244-025-02003-8