A Trial of Fimasartan for Early Diastolic Heart Failure

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Approximately half of hypertensive patients have diastolic dysfunction and diastolic dysfunction is associated with development of congestive heart failure and increased mortality. Although diastolic heart failure associated with hypertension is a clinically significant problem, few clinical trials have been conducted and there is no proven pharmacological therapy to improve outcomes. To the best of the investigators knowledge, there has been no randomized trial to demonstrate that an antihypertensive drug improves diastolic function in hypertensive patients with diastolic dysfunction. The investigators hypothesize that fimasartan added to standard therapy will be superior to placebo in improving diastolic dysfunction in mildly symptomatic patients with hypertension and diastolic dysfunction, and try to examine this hypothesis in a double-blind, randomized comparison study using echocardiography.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Boryung Pharmaceutical Co., Ltd
• Treatments: Antihypertensive Agents

Criteria

Inclusion Criteria:

• Untreated hypertension: systolic BP ≥ 140 or diastolic BP ≥ 90 mmHg or Treated hypertension

• Current heart failure symptoms with NYHA class II

• Evidence of diastolic dysfunction showing any 2 of the following:

E/E' > 10, LV posterior wall thickness > 11 mm, BNP level > 40 pg/mL

Exclusion Criteria:

• Planned cardiac surgery or planned major non-cardiac surgery within the study period

• Stroke or coronary revascularization in the past 6 months

• LV ejection fraction < 50%

• Hypertrophic or restrictive cardiomyopathy, moderate or severe valve disease, constrictive pericarditis

• Atrial fibrillation with a heart rate > 120/min

• Sitting systolic BP < 100 mmHg

• Sitting systolic BP > 160 mmHg or diastolic BP > 95 mmHg despite antihypertensive therapy

• Significant renal disease manifested by serum creatinine > 2.5 mg/dL

• Clinically significant pulmonary disease, coronary artery disease

• A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer

• Female of child-bearing potential who do not use adequate contraception and women who are pregnant or breast-feeding