Study Summary
This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 22 Secondary · Reporting Duration: 18 weeks (includes 2 weeks period off-treatment period)
16 weeks
Adherence to the study drug administration schedule
Change in IVC collapsibility index from baseline to 16 weeks
Change in eGFR from baseline to 16 weeks, assessed by 24-hour averaged urien urea and creatinine clearance
Change in left atrial volume index from baseline to 16 weeks
Change in pre-HD hsTnT from baseline to 16 weeks
Change in pre-dialysis NTpro-BNP from baseline to 16 weeks
Changes in SMaRRT-HD and Dialysis Symptom Index questionnaire scores from baseline to 16 weeks
Proportion of participants able to complete the full 16 weeks of treatment
Proportion of participants able to reach maximum dose titration
Pharmaceutical Preparations
18 weeks
All-cause mortality
Death from cardiovascular causes
Heart failure hospitalization/ hospitalization with volume overload
Heart failure
Rates of recruitment, withdrawal, and loss-to-follow-up
Week 18
Adverse Events
Adverse Events frequency
Angioedema
Angioedema frequency
Hyperkalemia (pre-dialysis serum potassium >5.5 mmol/L)
Hyperkalemia
Inter-dialytic hypotension (symptomatic SBP <90 mmHg or hypotension requiring adjustment in blood pressure medications or treatment in an emergency or hospitalized setting)
Inter-dialytic hypotension (symptomatic SBP <90 mmHg or hypotension requiring adjustment in blood pressure medications or treatment in an emergency or hospitalized setting) frequency
Intra-dialytic hypotension (defined as nadir SBP <90 mmHg if pre-HD SBP≤160 mmHg, or nadir SBP <100 mmHg if pre-HD SBP >160 mmHg)
Hypotension
Serious Adverse Events
Serious Adverse Events frequency
Baseline
Reasons for ineligibility
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
sacubitril/valsartan
1 of 2
placebo
1 of 2
Experimental Treatment
Non-Treatment Group
100 Total Participants · 2 Treatment Groups
Primary Treatment: sacubitril/valsartan · Has Placebo Group · Phase 2
sacubitril/valsartan
Drug
Experimental Group · 1 Intervention: Sacubitril-valsartan · Intervention Types: DrugplaceboPlaceboComparator Group · 2 Interventions: Placebo, Sacubitril-valsartan · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 weeks (includes 2 weeks period off-treatment period)
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,122 Previous Clinical Trials
4,062,656 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,472 Previous Clinical Trials
9,735,165 Total Patients Enrolled
Finnian Mc Causland, MBBCh, MMScPrincipal InvestigatorBrigham and Women's Hospital
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have not taken an ACEi for 36 hours prior to randomization.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 9th, 2021
Last Reviewed: November 13th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- McMurray, John J.V., Milton Packer, Akshay S. Desai, Jianjian Gong, Martin P. Lefkowitz, Adel R. Rizkala, Jean L. Rouleau, et al.. 2014. “Angiotensin–neprilysin Inhibition Versus Enalapril in Heart Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1409077.
- Mc Causland FR, Lefkowitz MP, Claggett B, Anavekar NS, Senni M, Gori M, Jhund PS, McGrath MM, Packer M, Shi V, Van Veldhuisen DJ, Zannad F, Comin-Colet J, Pfeffer MA, McMurray JJV, Solomon SD. Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Sep 29;142(13):1236-1245. doi: 10.1161/CIRCULATIONAHA.120.047643. Epub 2020 Aug 17.
- Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Düngen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
- Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
- Finnian McCausland 2022. "Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05498181.
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