Therapeutic Drug Monitoring of Cardiac Medications

NCT03667781 | Terminated

• 1 other identifier: STU 032018-023
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will interview patients and providers of patients who have hypertension and are seen in cardiology clinic about ways to discuss therapeutic drug monitoring with patients. The investigators will use these interviews to crease discussion tools to discuss therapeutic drug monitoring. The investigators will then draw one venous blood sample in a different group of patients who are seen in interventional clinic for 1 month followup after PCI. The investigators will assay this blood for therapeutic drug monitoring and will provide the results to their providers for discussion at their regularly scheduled followup cardiology visit. The investigators will have the patients and providers fill out a survey afterwards to determine how they viewed therapeutic drug monitoring.

Conditions

Hypertension; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Assessed by survey

  Followup visit at 1 month from the initial visit

Secondary Outcomes (1)

• Provider Satisfaction

  Followup visit at 1 month from the initial visit

Study Arms (3)

Patients Interviewed

Patients in cardiology clinic with uncontrolled hypertension despite being on 2 medications

Providers Interviewed

Providers in cardiology clinic

Patients Blood Draw

Patients seen in interventional clinic for post PCI followup will have a venous blood draw which will be sent for therapeutic drug monitoring

Diagnostic Test: Therapeutic drug monitoring

Interventions

Therapeutic drug monitoring DIAGNOSTIC_TEST

Blood assay to evaluate for the presence of medications that the patient is prescribed. This is not being used for therapeutic purposes. It has already been validated in prior papers.

Patients Blood Draw

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients and providers seen in cardiology clinic for interview component. Patients seen in interventional clinic for their post PCI followup for the blood draw component.

You may qualify if:

• Subjects age ≥ 18 to 80 years with uncontrolled hypertension (average clinic blood pressure of at least 130/80 mmHg despite treatment with 2 or more antihypertensive drugs).

You may not qualify if:

• Presence of hypertensive emergency BP \> 180/110 mmHg plus one of the following features: acute coronary syndrome, acute stroke, hypertensive encephalopathy, aortic dissection, or acute kidney injury,
• History of active substance abuse such as alcohol, cocaine, or narcotics
• Uncontrolled psychiatric disorder such as schizophrenia or major depression
• Pregnancy
• Homeless
• Stage V CKD or end stage renal disease (glomerular filtration rate \< 15 ml/min/1.73 m2),
• Self-report of nonadherence or unwillingness to follow medication regimen prescribed by the primary care physicians for any reasons,
• Presence of white coat hypertension (defined as normal 24-h ambulatory systolic BP or home BP of \< 130 and diastolic BP of \< 80 mmHg and clinic systolic BP of at least 140 mmHg or diastolic BP of at least 90 mmHg according to the AHA guidelines)
• Inability to read or write English, because participants may not be able to follow all study procedures or complete study questionnaires and surveys correctly which may lead to inaccurate data collection.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Hypertension; Coronary Artery Disease

Interventions

Drug Monitoring

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wanpen Vongpatanasin

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 12, 2018
• Study Start: August 1, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 14, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)