OPTICARD: Optimizing Treatments for Heart Failure During Hospitalization

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05910437
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 12
• Patients Per Site: 100
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

Heart failure reaches 1.5 million people in France and is responsible for 200,000 hospitalizations per year.

Over the past ten years, new therapies have emerged (treatment of martial deficiency, Entresto, iSGLT2).

Hospitalization in a context of acute heart failure is a moment of choice in the history of the disease to introduce recommended treatments under closer supervision (clinical, biological) than in ambulatory, and allows a decrease in hospitalizations, morbidity and mortality.

The purpose of this study is to describe the introduction of heart failure drugs (including iSGLT2) in real-life settings in patients hospitalized for decompensated heart failure.

Condition or Disease	Intervention/Treatment	Phase
Decompensated Heart Failure	Other: Hospitalized patient for decompensated heart failure

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Optimizing Treatments for Heart Failure During Hospitalization
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Outcome Measures

Primary Outcome Measures

1. Prescription score [During hospitalisation for decompensated heart failure (up to 10 days)]

   Prescription score, ranging from 0 to 10, each type of heart failure treatment (IEC/ARA2, Sacubitril, betablockers, SGLT2i, MRA) being evaluated on a scale of 2.

Secondary Outcome Measures

1. serum concentration of creatinine [During hospitalisation for decompensated heart failure (up to10 days)]

   Creatinine measured at admission and discharge

2. serum concentration of potassium [During hospitalisation for decompensated heart failure (up to 10 days)]

   Potassium measured at admission and discharge

3. Concentration of hemoglobin [During hospitalisation for decompensated heart failure (up to 10 days)]

   hemoglobin measured at admission and discharge

4. All cause Death [6 months]

5. Rate of hospitalization for heart failure [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient ≥ 18 years

• Hospitalized (≥24h) for decompensated heart failure in cardiology.

Exclusion Criteria:

• Patient opposition participation in research and use of data.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chr Metz Thionville	Ars-Laquenexy		France	57530
2	CHRU de NANCY	Vandœuvre-lès-Nancy		France	54500

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Study Chair: Nicolas GIRERD, MD-PhD, CHRU de NANCY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr. Nicolas GIRERD, coordinating investigator, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05910437
• Other Study ID Numbers: 2022PI115
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pr. Nicolas GIRERD, coordinating investigator, Central Hospital, Nancy, France: Decompensated heart failure
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jun 18, 2023