Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Beta-blockers improve clinical outcomes in heart failure and reduced ejection fraction (HFrEF); but not in those with preserved EF. Global longitudinal strain (GLS) is a prognostic factor independent of left ventricular ejection fraction (LVEF). In a retrospective with 1969 patients with HF and LVEF of ≥40%, beta-blocker was associated with improved survival in those with low GLS (GLS \<14%), but not in those with GLS ≥14%. In this prospective, randomized clinical study, the investigators will assess the effect of slow-release carvedilol in patients with HFpEF and hypertension. The primary endpoint is the time-averaged proportional changes in NT-proBNP level and GLS change from baseline to month 6.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• age ≥20 yrs

• symptomatic HFpEF with LVEF≥50%

• NT-proBNP ≥220 pg/ml (sinus rhythm) or ≥660 pg/ml(AF) (BNP ≥80 pg/ml (sinus rhythm) or ≥240 pg/ml(AF) )

• SBP≥140mmHg and/or DBP ≥90mmHg, or if taking anti-hypertensive medication, SBP ≥110mmHg.

• LAVI≥29(sinus rhythm)/34ml/m2 (AF) or LVMI≥115(male)/95(female) g/m2

• meet one the following

‣ Average E/e'≥ 9

⁃ Septal e' \< 7 cm/s

⁃ Lateral e' \<10 cm/s

⁃ TR velocity \> 2.8 m/s

⁃ PASP \> 35 mmHg

⁃ GLS \< 16%

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Wonju Severance Christian Hospital
RECRUITING
Wonju
Contact Information
Primary
Jin Joo Park, MD, PhD
jinjooparkmd@gmail.com
+82317877074
Time Frame
Start Date: 2021-11-17
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 100
Treatments
Experimental: Carvedilol-group
Patients receiving carvedilol
Placebo_comparator: Placebo-group
Patients receiving placebo
Sponsors
Collaborators: Samsung Medical Center, Wonju Severance Christian Hospital
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov