Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05089149

Evaluation of Congestion in Outpatients with Chronic Heart Failure CHF-COV Study

Led by Pr. Nicolas GIRERD · Updated on 2023-06-05

200

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating markers of congestion in patients with chronic heart failure (HF), a leading cause of hospitalization and death in older adults. This study aims to identify clinical, biological, and ultrasound markers measured during scheduled consultations or day hospitalizations that are linked to the risk of death or hospitalization due to acute heart failure within 24 months. Understanding these markers could help improve monitoring and management of chronic HF. Participants will undergo a clinical exam focused on congestion, including the use of specific scoring systems, and several types of Doppler ultrasounds of the heart, lungs, peritoneum, jugular and renal veins, along with optional liver elastography. Blood samples will be taken for biological assessments and biobanking. Follow-up will be conducted by telephone at 3, 12, and 24 months after the initial visit. Patients will also complete a quality of life questionnaire at discharge and during follow-ups. During the study, participants will be closely monitored through clinical exams, ultrasounds, laboratory tests, and questionnaires assessing quality of life. The primary outcomes measured are the rates of all-cause death and hospitalization for acute heart failure over 24 months. Secondary outcomes include cardiovascular hospitalizations, death rates, heart function class, various blood markers, renal function, plasma volume, liver status, and patient quality of life. The study ensures ongoing safety monitoring through regular follow-ups and assessments over two years.

CONDITIONS

Brief Title

Chronic Heart Failure - COngestion eValuation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with chronic heart failure admitted for scheduled day hospitalization or consultation
  • Age 18 years or older
  • Patients who have received complete information and signed informed consent
  • Affiliated to or beneficiary of a social security scheme
Not Eligible

You will not qualify if you...

  • Comorbidity with life expectancy of 3 months or less
  • Patients on peritoneal dialysis or hemodialysis, or with glomerular filtration rate below 15 ml/min/m2
  • History of lobectomy or pneumonectomy lung surgery
  • Severe pulmonary or pleural disease preventing reliable lung ultrasound imaging, such as severe emphysema, chronic pleurisy, or pulmonary fibrosis
  • Pregnant women, parturient, or nursing mothers
  • Adults under legal protection measures
  • Adults unable to give consent
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under psychiatric care according to specific public health codes

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for scheduled day hospitalization or consultation

Diagnostic Evaluation

Duration - Day hospitalization or consultation

Participants undergo clinical examinations focused on congestion, including Doppler ultrasounds and blood sample collection for biological assessment and biobanking.

1 visit (in-person) for day hospitalization or consultation

Long-term Monitoring

Duration - Up to 24 months

Participants are followed up with telephone calls and quality of life questionnaires to assess health status over time.

Telephone follow-ups at 3, 12, and 24 months; quality of life questionnaires at discharge and 3, 6, 12, and 24 months

Trial Site Locations

Total: 2 locations

1

CHRU de Nancy

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

2

CHRU de Nancy

Vandœuvre-lès-Nancy, France, 54500

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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