Immediate Release Versus Slow Release Carvedilol in Heart Failure

Heart Failure With Reduced Ejection Fraction Clinical Trial

— SLOW-HF  

Official title:

Assessment of Clinical Effect and Treatment Quality of Rapid Release Carvedilol Versus SLOW Release Carvedilol-SR in HEART FAILURE Patient (SLOW-HF): A Prospective Randomized, Open-label, Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209180
• Other study ID #: CVDSR
• Status: Recruiting
• Phase: Phase 4
• First received: July 3, 2017
• Last updated: July 3, 2017
• Start date: October 27, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of clinical effect and treatment quality of immediate release carvedilol (IR) versus slow release carvedilol (SR) in patients with HFrEF

Description:

The SLOW-HF trial is a phase 4, randomized, open label, multicenter study to evaluate the therapeutic efficacy of carvedilol-SR compared to carvedilol-IR in patients with heart failure with reduced ejection fraction. Patients with stable HFrEF will be randomly assigned (1:1) to carvedilol SR group (160 patients) and carvedilol IR group (160 patients).

After randomization, patients will be followed for 6 months. The primary endpoint is the change in NT-proBNP level from baseline to the study end. The secondary endpoints include the frequency of NT-proBNP increment >10% from baseline, composite of all-cause mortality and readmission, mortality rate, readmission rate, changes in blood pressure, quality of life, and drug compliance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

1. At least or more than 20-years-old male and female

2. Confirmed left ventricular ejection fraction =40% by echocardiography within pre-analytical 6 months

3. NT-proBNP level = 125 pg/ml or BNP level = 35 pg/ml within pre-analytical 3 months

4. Clinically stable patient without evidence of congestion or extracellular fluid retention; those could be candidate of ß-blockers

5. Patients providing written informed consent

Exclusion Criteria:

1. Systolic blood pressure at sitting position < 90mmHg or resting heart rate < 50 /min at screening

2. Patient has a contraindication to ß-blockers

3. Patient who are expected to take another ß-blocker after randomization

4. Cardiovascular diseases

• Ischemic heart disease (unstable angina, myocardial infarction) within 1 month

• Hypertrophic cardiomyopathy

• Cor pulmonale

• Hemodynamically significant stenosis of aorta, aortic valve, or mitral valve

• any acute myocardial infarction with complication

5. Severe cerebrovascular accident (for example, ischemic stroke or cerebral hemorrhage) pre-analytical within 6 months

6. Glottis edema, allergic rhinitis, respiratory diseases with bronchospasm such as asthma and chronic obstructive lung disease

7. Peripheral vascular disease (for example, Raynaud syndrome, intermittent claudication)

8. Patients who need vasopressor due to prominent volume retention/overload

9. Moderate to Severe retinopathy (for example, retinal hemorrhage, visual disturbance, retinal microaneurysm within 6 months)

10. Impaired renal function (Serum creatinine = 2.5 mg/dL) or hepatic function (AST or ALT = 3 x ULM)

11. Patients in clinical status that can significantly influence on absorption, distribution, metabolism, and secretion of drugs for clinical trial

• history of major gastrointestinal surgery, such as gastrectomy or gastric bypass surgery

• inflammatory bowel disease within 12 months

• current gastric ulcer, pancreatic function abnormality including pancreatitis, gastrointestinal/rectal bleeding which demand treatment

• current urologic stenosis or obstruction which demand treatment

12. Confirmed or suspected drug/alcohol abuse within 6 months

13. Pregnant or lactating women, suspected pregnant women or lactating women

14. Chronic inflammatory diseases which demand anti-inflammatory treatment

15. Hypersensitivity to carvedilol

16. Malignant disease including lymphoma and leukemia within 5 years

17. Patients who were prescribed other medication for any clinical trials pre-analytical within 28 days

18. Patients who are predicted to have prolonged hospital days due to other medical problems other than chronic heart failure (for example, femur neck fracture)

19. Patients who are considered as inappropriate to participate in the clinical trial by testers

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• CarVeDilol-SR (Slow Release)
patients will receive slow-release carvedilol (SR) once daily
• Carvedilol IR (Immediate Release)
patients will receive immediate release carvedilol (IR) twice daily

Locations

Country	Name	City	State
Korea, Republic of	Sejong Hospital	Gyeonggi-do	Bucheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul	Songpa
Korea, Republic of	Gangdong Sacred Heart Hospital	Seoul	Gangdong
Korea, Republic of	Korea Univ. Anam Hospital	Seoul	Seongbuk
Korea, Republic of	Korea Univ. Guro Hospital	Seoul	Guro
Korea, Republic of	Samsung Medical Center	Seoul	Il-won
Korea, Republic of	Seoul Medical Center	Seoul	Jungnang
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou Univ. Medical Center	Suwon-si	Yeong-tong
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Chong Kun Dang Pharmaceutical Corp.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP	Change of NT-proBNP from baseline to 6 months after randomization	6 months
Secondary	All-cause Death	Difference in all-cause deaths between the groups during clinical follow-up	6 months
Secondary	Hospitalization	Difference in hospitalization for heart failure between the groups during clinical follow-up	6 months
Secondary	Blood Pressure	Difference in blood pressure change between the groups during clinical follow-up	6 months
Secondary	Dyspnea	Differences in dyspnea measured with visual analogue scale between the groups during clinical follow-up	6 months
Secondary	Drug compliance	Differences in drug compliance measured with 'pill-count' between the groups during clinical follow-up	6 months