An observational study in Heart Failure, Systolic, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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Among 83 studies in Heart Failure, Systolic with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Heart Failure, Systolic · United States.
Among the 83 studies in Heart Failure, Systolic with a site in United States, this one is the 5th largest by enrollment of the 14 observational ones that give a count, is one of 10 that started in 2018, is one of 14 observational ones, and was the 32nd registered.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
Browse Heart Failure, Systolic studies →17 of the 83 studies in Heart Failure, Systolic with a site in United States are open now. Recruiting first, the newest first:
Abiomed Inc. · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Kaiser Permanente · Sites in United States
Ages 18+
Impulse Dynamics · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 2 · Phase 4 8
First in 2005; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 402 is above the median of 250 across 54 observational studies indexed under Heart Failure, Systolic.
Median enrollment 40 across the 69 interventional studies, 148 across the 14 observational. Of the 48 that completed or were terminated, 17 (35%) have results posted.
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24 of 83 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis has 6 studies filed under Heart Failure, Systolic — fewer than ten, so there is no comparison to draw.
7 of the studies in Heart Failure, Systolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925608BioCardia, Inc.Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells | 2026-12 |
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT06671015Yale UniversityA Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure | 2027-01 |
| NCT07252310Weill Medical College of Cornell UniversityPilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App) | 2027-02 |
| NCT05230732University of OklahomaNeuromodulation of Inflammation and Endothelial Function | 2027-02-27 |
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Among the 83 studies in Heart Failure, Systolic with a site in United States, from their registry updates:
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Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.
This is a prospective cohort study of 400 chronic HF patients that will also examine and describe retrospective electronic health record data. We will use the PCORnet (Patient Centered Outcomes Research Network, see "data sources" below) infrastructure to (1) identify a cohort of chronic systolic HF patients initiated on sacubitril/valsartan (N=200) as well as a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=200) but with background ACE/ARB therapy and (2) evaluate baseline and follow-up PROs via an electronic patient reported outcomes (ePRO) form in the eCOS database for 12 weeks.
400 adult patients with chronic systolic HF in PCORnet. We will focus on chronic systolic HF patients initiated on sacubitril/valsartan and a comparator group not initiated on sacubitril/valsartan sacubitril (but with background ACE/ARB therapy and recent titration of these medications).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Other protocol inclusion/exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic systolic heart failure patients newly prescribed in mg. twice daily.
Drug: Sacubitril/Valsartan
Chronic systolic heart failure patients receiving ACEi/ARB and no s/v
Drug pages: Sacubitril · Valsartan
commercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103
Change from baseline to 12 weeks in the KCCQ
Kansas City Cardiomyopathy Questionnaire (KCCQ) - self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life in patients with heart failure.
Time frame: Baseline to weeks 2, 4, 8 and 12
Responder analysis for a 5-point improvement in KCCQ to week 12
Binary response for a 5-point improvement in KCCQ to week 12
Time frame: Baseline to week 12
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Ran from Feb 2018 to primary completion in Jun 2019, 16 months.
Of 27 observational studies under Heart Failure, Systolic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 53. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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