NCT01691118

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Sep 2012

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

September 20, 2012

Last Update Submit

December 29, 2015

Conditions

Hypertension

Keywords

HypertensionAngiotensin Receptor BlockerDiastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in E/E' ratio

    Change in the ratio of E velocity (Early mitral inflow velocity) to E' velocity (Early mitral annular velocity) from baseline to 10 months follow-up.

    10 months

Secondary Outcomes (6)

  • Change in BNP levels

    10 months

  • Change in left ventricular mass

    10 months

  • Change in left atrial volume

    10 months

  • Change in global left ventricular strain

    10 months

  • Change in functional class

    10 months

  • +1 more secondary outcomes

Study Arms (2)

Fimasartan

ACTIVE COMPARATOR

Fimasartan 60mg qd added on conventional antihypertensive treatment for 10 months.

Drug: FimasartanDrug: Antihypertensive treatment

Placebo

PLACEBO COMPARATOR

Conventional antihypetensive treatment

Drug: Antihypertensive treatment

Interventions

FimasartanDRUG
Fimasartan
Antihypertensive treatmentDRUG
FimasartanPlacebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Duk-Hyun Kang, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 24, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

KR(1)