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NCT04458285: ESARHD-HF
Efficacy and Safety of Sacubitril/Valsartan in Maintenance Hemodialysis Patients With Heart Failure
NA trial testing Sacubitril / Valsartan Oral Tablet [Entresto] in Hemodialysis Complication in 118 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Guangdong Provincial People's Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 118 |
| Start date | 1 January 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sacubitril / Valsartan Oral Tablet [Entresto] — full drug profile →
- Valsartan 80mg Tablet — full drug profile →
Conditions studied
- Hemodialysis Complication — all drugs for Hemodialysis Complication →
- Heart Failure — all drugs for Heart Failure →
Sponsor
Guangdong Provincial People's Hospital
Who can join
Adults 18 to 80, any sex, with Hemodialysis Complication or Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Sacubitril/valsartan reduces the risk of cardiovascular mortality among patients with heart failure with reduced ejection fraction, and has been recently indicated as a new treatment option with a strong level of recommendation (class I, level of evidence B) in the main international guidelines. Cardiovascular disease (CVD) is the most common cause of death in end stage renal disease (ESRD) patients undergoing hemodialysis (HD). Hence, treatments to improve mortality and specifically cardiovascular outcomes in this population are greatly needed. So far, no data available about the efficacy and safety of sacubitril/valsartan in ESRD patients undergoing hemodialysis, although this medication was noted to be effective and comparably well tolerable in those with estimated glomerular filtration rate(eGFR) 20 to 60 mL/min/1.73 m2 in the United Kingdom Heart and Renal Protection-III trial. The purpose of this open label, randomized controlled study with prospective data collection is to assess the efficacy and safety of sacubitril/valsartan in maintenance hemodialysis patients with heart failure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04458285
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Related trials
Other trials of Sacubitril / Valsartan Oral Tablet [Entresto]
Trials testing the same drug.
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- NCT04853758 — Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: ANSWER-HF. · Phase 3 · recruiting
- NCT04753112 — Treatment of PH With Angiotensin II Receptor Blocker and Neprilysin Inhibitor in HFpEF Patients With CardioMEMS Device · Phase 3 · completed
- NCT03893435 — The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction · NA · completed
Other recruiting trials for Hemodialysis Complication
Currently open trials in the same condition.
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- NCT07512895 — The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treat · NA · recruiting
- NCT07047547 — A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure · NA · recruiting
- NCT06452563 — Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients · Phase 4 · active not recruiting
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Other Guangdong Provincial People's Hospital trials
Trials by the same sponsor.
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- NCT07472478 — Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12 · Phase 2 · not yet recruiting
- NCT07483398 — RELIEF-PD: Crisugabalin for Nociplastic Pain in Parkinson's Disease · Phase 4 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04458285 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangdong Provincial People's Hospital
- Last refreshed: 6 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04458285.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing