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NCT06532019Not yet recruiting

Clinical Study of Active Intervention in High-risk HFpEF Patients

Randomized Multicenter Clinical Trial in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) at Intermediate and High Risk of All-cause Death

Source: ClinicalTrials.gov · Last updated 1 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Based on inclusion and exclusion criteria, this experiment plans to include 924 Heart Failure with Preserved Ejection Fraction(HFpEF) patients with increased risk of all-cause death. The enrolled patients will divided into usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care patients will receive routine heart failure treatment. Patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower N-terminal pro brain natriuretic peptide (NT-proBNP), C-reactive protein(CRP), New York Heart Association(NYHA )Classification, to add diuretics for patients with higher right ventricular diameters(RADs),multidiscipline intervention for patients complicating chronic obstructive pulmonary disease(COPD), and actively reperfusion for ischemic HFpEF patients. The incidence of all-cause death will be compared after 3 years follow-up.The primary endpoint is the occurrence of all-cause mortality events during the follow-up period.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
924 (estimated)
First submitted
27 Jul 2024
Start date
1 Aug 2024
Primary completion date
1 Aug 2027
Lead sponsor
Xiangtan Central Hospital
NCT number
NCT06532019

What you commit to

  • Study type: Interventional
  • Planned participants: 924
  • From 1 Aug 2024 to the primary completion date, 1 Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with a life expectancy of less than 1-year due to malignancy.

Who the study is looking for

  • Discharged HFpEF patients with risk score \> or equal 200.37.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.