Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

NCT05613140 | Completed

• 1 other identifier: CLCZ696BUS33
• Study Type: observational
• Target: 9,230
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).

Conditions

Chronic Heart Failure

Keywords

Heart failure,; Medicare Advantage,; Commercial,; HFrEF,; Chronic heart failure

Outcome Measures

Primary Outcomes (1)

• Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

  Number of Heart Failure (HF)-specific hospitalizations was defined as the number of acute inpatient hospitalizations with a primary discharge diagnosis of HF. An acute inpatient hospitalization was defined as a medical claim for an inpatient hospitalization.

  Baseline, 12 months post initiation of sacubitril/valsartan

Secondary Outcomes (13)

• Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

  Baseline, 12 months post initiation of sacubitril/valsartan

• Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

  Baseline, 12 months post initiation of sacubitril/valsartan

• Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan

  Baseline, 12 months post initiation of sacubitril/valsartan

• Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan

  Baseline, 12 months post initiation of sacubitril/valsartan

• Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan

  Baseline, 12 months post initiation of sacubitril/valsartan

Study Arms (2)

Cohort 1 - Adult HFrEF patients

adult HFrEF patients who newly initiated sacubitril/valsartan

Drug: sacubitril/valsartan

Cohort 2 - Adult CHF patients

adult CHF patients who newly initiated sacubitril/valsartan

Drug: sacubitril/valsartan

Interventions

sacubitril/valsartan DRUG

Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).

Cohort 1 - Adult HFrEF patients; Cohort 2 - Adult CHF patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with heart failure with reduced ejection fraction (HFrEF) and adult patients with chronic heart failure (CHF)

You may qualify if:

• Cohort 1 - Adult HFrEF patients
• Newly initiated sacubitril/valsartan during the cohort identification period;
• Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
• That are ≥ 18 years old at index date;
• That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
• That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed.
• Cohort 2 - Adult CHF patients
• Newly initiated sacubitril/valsartan during the cohort identification period;
• Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x, I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
• That are ≥ 18 years old at index date;
• That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
• That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed.

You may not qualify if:

• \- Patients who died during the post-index period will be excluded.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CLCZ696BUS33 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 14, 2022
• Study Start: August 2, 2021
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)