Anti-Hypertensive Agent (ACEi) and Heart Function Improvement in Association With Rho Kinase Activity Changes in Human

NCT01069042 | Unknown Phase 4

• 1 other identifier: HR-98-096
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Rho, one of the small GTPase proteins, and its downstream target molecule, Rho-kinase (ROCK), play important roles in mediating various cellular functions, including contractility, actin cytoskeleton organization, cell adhesion and motility, proliferation, cytokinesis and gene expressions, all of which are involved in the pathogenesis of cardiomyocyte contractility and other vascular disease. The investigators thus hypothesize that ROCK pathway plays an important role in the function and severity of heart failure (HF) and can be one of the possible pathway that currently applied cardiovascular medicine affecting their prognosis among HF treatment. Previous study has shown that in patients with HF, intra-arterial infusion of fasudil causes preferential increase in forearm blood flow as compared with control subjects, suggesting an involvement of Rho/Rho-kinase pathway in the increased peripheral vascular HF failure remain to be examined. Besides, whether the rho kinase activity was enhanced or their response to current medication in HF patients remained unsolved. Aim: ROCK activity and left ventricular function between HF or non-HF population survey and their response to ACEi Tx.

Conditions

Heart Failure

Keywords

Rho kinase activity; Heart failure; ACE inhibitor; LVEF change; Rho kinase activity change

Outcome Measures

Primary Outcomes (1)

• The primary outcomes are the mean changes in the Rho-kinase activity in leukocytes before and after periods of treatment.

  3 and 6 months

Secondary Outcomes (1)

• The correlation between the mean changes in Rho-kinase activity in leukocytes and cardiac function measured by echocardiography.

  3 and 6 months

Study Arms (2)

preserved LVEF under ACEi treatment

ACTIVE COMPARATOR

preserved LVEF under ACEi treatment

Drug: Enalapril

Poor LVEF group

EXPERIMENTAL

Poor LVEF under ACEi treatment

Drug: Enalapril

Interventions

Enalapril DRUG

All subjects will initially receive 10mg of enalapril and be gradually titrated up to 20mg with blood pressure tolerance for 6 months.

Also known as: Renitec

Poor LVEF group; preserved LVEF under ACEi treatment

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• those subjects aged from 16 to 80 years
• diagnosed as systolic hypertension

You may not qualify if:

• renal insufficiency (serum creatinine ≥ 2.5 mg/dl)
• hyperkalemia (serum potassium ≥ 5mmol/L)
• with systemic inflammatory disease, including history of autoimmune disease, malignance; bilateral renal artery stenosis
• prior intolerance of an angiotensin receptor blockade (ARB) or ACE
• ACEi or ARB use within recent 1 month
• record of symptomatic hypotension

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 70401, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Enalapril

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jyh-Hong Chen, MD, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping-Yen Liu, MD, PhD

CONTACT

886-6-2353535; larry@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 25, 2010

Record last verified: 2010-02

Locations

TW (1)