Clinical Study of Active Intervention in High-risk HFpEF Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiangtan Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Discharged HFpEF patients with risk score > or equal 200.37.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted intervention based on risk factors

    Other intervention

    Correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower NT-proBNP, CRP, NYHA Classification, to add diuretics for patients with higher RADs, multidiscipline intervention for patients complicating COPD, and actively reperfusion for ischemic HFpEF patients.

Treatment groups

924 Participants
are divided into 2 treatment groups
Group A: usual care groupNo intervention 0 interventions
Group B: targeted intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

all-cause mortality

follow-up by clinical visit, telephone call or community visit

Time frame
The patients will be followed up for 3 years after they were enrolled.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangtan Central Hospital

Lead sponsor

The First People's Hospital of Xiangtan City

Collaborator

The Xiangtan People's Hospital

Collaborator

The Xiangxiang People's Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: